| Revision as of 05:31, 31 March 2007 editRegulations (talk | contribs)471 edits →Reading Material for []← Previous edit | Latest revision as of 14:36, 27 September 2024 edit undoLowercase sigmabot III (talk | contribs)Bots, Template editors2,299,798 editsm Archiving 1 discussion(s) to Talk:Food and Drug Administration/Archive 2) (bot | ||
| (302 intermediate revisions by more than 100 users not shown) | |||
| Line 1: | Line 1: | ||
| {{ |
{{Skip to talk}} | ||
| {{ |
{{Talk header}} | ||
| {{Not a forum}} | |||
| {{WikiProject banner shell|class=C|vital=yes|1= | |||
| {{archive box| | |||
| {{WikiProject Food and drink|importance=high}} | |||
| #] | |||
| {{WikiProject Pharmacology|importance=high}} | |||
| #] | |||
| {{WikiProject Medicine |importance=Low |toxicology=yes |toxicology-imp=high |society=yes |society-imp=top}} | |||
| {{WikiProject Alternative medicine}} | |||
| {{WikiProject Organizations|importance=Low}} | |||
| {{WikiProject Maryland|importance=mid}} | |||
| {{WikiProject Drug Policy |importance=High}} | |||
| {{WikiProject Science Policy |importance=High}} | |||
| {{WikiProject United States|importance=Low|USGov=yes|USGov-importance=Low}} | |||
| {{WikiProject Politics|importance=low|American=yes|American-importance=low}} | |||
| }} | |||
| {{Archive box| | |||
| #] | |||
| #] | |||
| }} | |||
| {{User:MiszaBot/config | |||
| |archiveheader = {{aan}} | |||
| |maxarchivesize = 100K | |||
| |counter = 2 | |||
| |minthreadsleft = 10 | |||
| |minthreadstoarchive = 1 | |||
| |algo = old(90d) | |||
| |archive = Talk:Food and Drug Administration/Archive %(counter)d | |||
| }} | }} | ||
| == Move article to US Food and Drug Administration == | |||
| I think a better title should be considered for the article, "Food and Drug Administration" sounds odd and US-centric. Notice that it was suggested before (see above) that the article should be moved to "United States Food and Drug Administration". I would vote for the more simple "US Food and Drug Administration". ] (]) 00:00, 4 October 2012 (UTC) | |||
| ==Criticism: Delays in drug approval section== | |||
| :"Food and Drug Administration" is the actual name of the organization. There is no other organization with this name in any other country. Per ] Misplaced Pages uses the actual name of things for the article title unless there is a reason to differentiate multiple items with the same name. ]] 12:56, 28 June 2014 (UTC) | |||
| Somebody is putting this POV back in: "In more recent times, the FDA's attention to more timely approval has been evident. For example, the recently approved HIV drug Fuzeon had a rapid turn-around time between the onset of clinical testing and final approval. The New Drug Application ("NDA"), the manufacturer's license to ship the drug across state lines for clincal testing (see above), was approved on September 16, 2002. The drug was made available for compassionate use in October of 2002, and final approval was granted on March 13, 2003" They're neglecting to mention that the IND was filed in 1996. 1996-2003 is still a 7 year approval. How is that "more timely approval" when IND to approval in 1998 was 7 years as well? Maybe they mean more timely approval relative to the high of 10 years in 1970's? ] 15:21, 22 March 2007 (UTC) | |||
| ::A good point is that "FDA" to a very large extent has become synonymous with the US Food and Drug Administration. Even so, it turns out that there are other FDAs around, for instance the and the . Also, concerning the actual name used by the US FDA, the headline of the website says: . If you live in the US, UK, Canada, Australia, etc., I am sure that the term "Food and Drug Administration" is understood simply as a shortening of "U.S. Food and Drug Administration" but I would think that other English speakers/readers find it odd that "Food and Drug Administration" links directly to the U.S. Food and Drug Administration article instead of, for instance, a disambiguation page. --] (]) 15:30, 26 July 2014 (UTC) | |||
| :As I said before, I agree that Fuzeon is a poor example of rapid drug approval. I have added referenced information about accelerated approval of early HIV drugs & the comparison of their approval in the US vs. other countries. I left a shortened version of the Fuzeon blurb in because I think it illustrates why some drugs take longer to approve than others. -- ] 18:32, 22 March 2007 (UTC) | |||
| :Regulations, you should actually read the FDA article you are so adamant about editing. If you read it, you would understand that there is a difference between an IND and an NDA. The IND is the manufacturer's initial submission to the FDA that they are interested in starting clinical trials for the drug. Then the manufacturer does the clinical trials. The FDA and manufacturer have discussions during this time, sure, since the manufacturer wants to conduct a clinical trial that has a good chance of getting the drug approved, so the FDA advises the manufacturer on what the FDA considers to be an acceptable clinical trial. The key point here, Regulations, is that from the IND submission to the NDA submission, the onus is completely on the manufacturer to collect clinical data on the drug. The FDA isn't really involved at this point. The speed of the progress after the IND has more to do with manufacturer funding of clinical trials and how rapidly they can accrue patients. It also has to do with the quality of the data. If the clinical trials are poorly designed, the FDA can tell the manufacturer to go back and get more data, or get better data. ] allegedly found out about this very kind of advice in advance of its official announcement, and her ImClone stock was sold early, leading to an accusation of insider trading. So you see, the length of the "approval process" is indirectly dependent on the FDA, but also on a lot of other factors. I think a more accurate indicator of the speed of the FDA is to look at the time between the NDA and the final licensing for marketing, since this is a marker of how long the application data was stalled by the FDA bureaucracy. In many cases, the FDA comes out looking good. For a more recent example than Fuzeon, on the new cancer drug, Tykerb, the NDA was submitted on September 18, 2006, and marketing approval was granted on March 13, 2007, about six months. I think that's a reasonable amount of time for due diligence in a deadly disease, though some disagree.--] 05:59, 23 March 2007 (UTC) | |||
| ::I know that there is a difference betwen IND and NDA. Don't you see that the reason that the time between the IND and the NDA has increased is because the standards for approval have become more strict? Don't you realize that the increased regulations by the Kefauver Harris Amendment causes the need for extra time and extra precautions before submitting the NDA? The time to look at is most definitely from IND to final approval. It didn't take 6 years from IND to NDA before Kefauver. ] 15:33, 23 March 2007 (UTC) | |||
| :::So if your problem is that drug company clinical trials take a long time, all I can tell you is, beats the alternative. If you can think of a way to assess the safety and efficacy of a drug and not have it take six years, by all means, please let the world know. Really. We need new ideas on how to determine whether a drug is safe and effective in the fastest possible time. My cancer patients would be very happy to not have it take six years for a drug company to finish its clinical trials. They are also happy that I can recommend drugs that have a reasonable chance of success, and won't kill them, based on the FDA approval process. You seem to have a problem with the concept that clinical trials have a value to society. That idea of yours is just wrong, for many reasons. Your good health and that of your family is very likely the consequence of the tough regulations enacted by the Kefauver Amendments--I, for one, would not want to go back to the dangerous times before that regulation came around. In any case, the place to argue that the clinical trial is not a good way to determine the value of a drug is probably a blog somewhere, but not the Misplaced Pages entry on the FDA. You are entitled to your opinion, just not to express it in this particular venue. See below.--] 07:16, 24 March 2007 (UTC) | |||
| ::::First of all, stop being hypocritical. Don't tell me not to express my opinion here, when you're expressing your opinion as well. I do not oppose clinical trials, even 200 year clinical trials if necessary. I advocate and fully support clinical trials. What I oppose is the government forcibly setting the standards. The amount of testing a person required before he takes a medicine should be a decision between doctor and patient. You call yourself a doctor, but you don't even respect the natural rights of the patient to live his life as he sees fit. If an individual wants to wait for 20 years before he takes a drug, that should be his right. If he wants to take a drug without any testing at all, that should be his right as well. ] 17:21, 24 March 2007 (UTC) | |||
| ::Who should set standards for drug approval then, Reg? You? You sound like an intelligent person, but you have no idea how many medically ignorant people there are out there. You may not like government regulation of the speed limit either, but it keeps the freeway fatalities at a manageable number. Anarchy doesn't work with speed limits, and it isn't a meaningful standard for drug regulation either. We had drug deregulation in the 1930s, and what we got was a lot of snakeoil and elixirs. What we have now are lifesaving drugs. Again, your opinion about drug deregulation is a valid one, just not reflective of the state of the FDA now, so it doesn't belong in the article.--] 05:09, 25 March 2007 (UTC) | |||
| :I think the main purpose of Misplaced Pages is to erase ignorance, not to provide a platform for people to air a particular point of view.--] 05:59, 23 March 2007 (UTC) | |||
| ::A criticism section is definitely the place to air a particular point of view, that point of view being the point of view of the sources. ] 15:34, 23 March 2007 (UTC) | |||
| :::The criticism section is a place to ''concisely'' summarize ''noteworthy'' criticism of a subject. Right now it's bloated and mostly a ] to expound on a bunch of anti-FDA rhetoric. For instance, the whole "Criticism of over-regulation" section could be summed up as, "Some economists, such as Gary Becker and Milton Friedman, as well as libertarian organizations have criticized FDA regulation, claiming that it increases the cost of drugs and delays availability of potentially life-saving treatments." Add a few footnotes, and it's done. We really need to figure out how to make the criticism section more encyclopedic, concise, and readable. ''']''' <sup>]</sup> 22:13, 23 March 2007 (UTC) | |||
| ::::I disagree. It needs to be enyclopedic, lengthy and detailed. If it gets too large, just give it its own article. No worries. ] 00:38, 25 March 2007 (UTC) | |||
| ==How long should the criticism section be?== | |||
| Obviously we have an ongoing disagreement about the proper length and content of the criticism section. I'd like to avoid this becoming an all-out revert war. Here's my opinion: The primary purpose of this article is to give factual information about the FDA i.e. its history, its regulatory authority, the mechanisms by which it exerts that authority etc. A SECONDARY objective is to make people aware of the existance of specific, well-substantiated criticisms of the FDA, and to direct them to reputable sources by which they can further explore those issues if they care to do so. Because doing this presents serious potential for POV abuse and detraction from the primary purpose of the article, the criticisms and their rejoinders should be presented as concisely as possible. If it is felt that certain very important criticisms, which are well-substantiated by current evidence, cannot be conveyed concisely on this page, perhaps a separate page should be created to discuss those criticisms in a more in-depth manner. | |||
| To summarize: criticisms should be WELL-SUBSTANTIATED by CURRENT REFERENCES and should above all be CONCISE and BALANCED by equally well-substantiated and current REJOINDERS. | |||
| --] 03:47, 24 March 2007 (UTC) | |||
| I think some of the shorter sections I put together read a little better (as of this minute...see how long it lasts...) I like the AZT example, BTW.--] 07:17, 24 March 2007 (UTC) | |||
| Also, Rustavo, I like the idea of a specific FDA criticism page--let the "crackpots" have a special arena to air their gripes. | |||
| :Should be whatever length it takes to represent all the criticisms out there, such as the the view of 73% of neurologists and neurosurgeons that unapproved drugs should be made available with a warning label that they are unapproved. These are included in the "crackpots" that "Dr.michael.benjamin" speaks of. ] 19:58, 24 March 2007 (UTC) | |||
| ::You ''do'' realize that the survey you mentioned was conducted by the ], an explicitly partisan anti-regulation think tank with a clear axe to grind, and is in no way impartial, objective, or representative of the opinions of the majority of physicians, right? ''']''' <sup>]</sup> 00:29, 25 March 2007 (UTC) | |||
| :::You do realize that the Competitive Enterprise Institute didn't conduct the survey, right? The Polling Company did. The survey was a scientific survey that does indeed reflect the opnions on the majority of neurosurgeons and neurologists. ] 00:36, 25 March 2007 (UTC) | |||
| ::::Sorry, but the objectivity of that survey is, at the very best, extremely suspect. A brief glance at "the polling company's" other clients indicates their political leanings. And the bottom line is that it was performed under the aegis of the CEI. ''']''' <sup>]</sup> 00:40, 25 March 2007 (UTC) | |||
| :::::Oh well. Everybody is going to have a criticism for a survey they don't like. The Polling Company's reputations rests on the accurateness of their surveys, so I don't see any reason to think they did anything fraudulent. I thought it was pretty well known that doctors typically don't like the FDA, anyway. ] 00:49, 25 March 2007 (UTC) | |||
| ::::::I'm a doctor, and I really like the FDA. I think the Kefauver Amendment has saved thousands of lives by keeping dangerous drugs off the market. I can't speak for "most doctors," just myself :)--] 05:04, 25 March 2007 (UTC) | |||
| :::::::There are some questions on these surveys which flatly violate the principles of valid polling. For example, question 4 reads "In your opinion, to what extent does the public understand the human cost of the FDA approval process, that is, that some people may suffer or die waiting for the FDA to act?" That is a classic fallacious question in that it states a highly controversial premise as fact - it might as well read "To what extent does the public understand the way in which the FDA commissioner beats his wife?" The surveys use standard devices of political push-polling. It is revealing that the CEI never published these findings in a peer-reviewed journal, especially considering that surveys of doctors are frequently published in medical journals, and these surveys themselves reveal the premium placed by doctors on published research. I think the reason they were not published is obvious - the methodology is so biased and the questions so leading that the responses really can't be interperated. They were intended as a PR tool, not a scientific survey. | |||
| :::::::-] 05:10, 25 March 2007 (UTC) | |||
| ::::::::Whether the poll "violates the principles of valid polling" is your opinion. One can pick apart any poll. But your opinion on that really doesn't matter as far s this article is concerned. You would have to find a source disputing the poll and note that in the article. And yes the poll was not publised ina "peer-reviewed journal." Poll aren't usually published in peer-reviewed journals. There is no requirement that they be published in one in order to appear in a Misplaced Pages article. ] 17:22, 25 March 2007 (UTC) | |||
| ::::::::By the way, in regard to the question in the poll you're referring to, it's a given that some people may suffer or die waiting for the FDA act. There is nothing controversial about that. That's a self-evident truth. If there is medicine that someone needs to feel better or survive longer, and it's not approved, then that person may suffer or die. ] 17:26, 25 March 2007 (UTC) | |||
| :::::::::Yes, and it is uncontroversial that thousands of people "suffer and die" from drug side effects every year (even from good drugs that deserve to be on the market). By your logic, it would thus be perfectly fair to ask "To what extent is the public aware of the fact that people suffer and die from the FDA approving drugs too quickly." The real question is whether the FDA process overall is either too lax (so a net excess of people die from side effects) or too strict (so a net excess of people die witing for drugs) or in fact is about as good as a system run by humans could be. This is extremely controversial and you can find may medical professionals and other experts who will take any of those three positions. Also, opinion polling is not 'Nam - there are rules, and some particularly bad polls, like the CEI one you quoted - can be picked apart more easily than others.-] 03:49, 26 March 2007 (UTC) | |||
| :::::::::::Your personal criticism of the poll do not justify its removal from this article. But, if you want, leave out that question. I don't care. That one's not that important. More important are the questions like "The FDA is too slow in approving new drugs and medical devices." 67% and "What would your position be on a proposal to change FDA law so that unapproved drugs or devices could be made available to physicians as long as they carried a warning about their unapproved status?" 73%. Do you see a problem with those questions? ] 06:16, 26 March 2007 (UTC) | |||
| Look, if you want to keep the poll, that's fine, but ''it needs to be made explicit'' that the poll was commissioned by the CEI. The CEI is (in)famous for (mis)using the trappings of science in the service of its paymasters. They used to be a tobacco-industry attack dog, going after the FDA and EPA on second-hand smoke (see , under "Non-tobacco attacks on FDA", or just search the declassified tobacco documents for "Competitive Enterprise Institute"). Then they moved on to misquoting the scientific literature on global warming (see ) for ExxonMobil. So you'll excuse my skepticism about the objectivity of this poll. The major question, in my mind, is how the sample group was selected. This is probaby ''the'' major question for any opinion poll, but it's glossed over here - the poll says the respondents were "selected and screened" from a random sample. Selected and screened how? On what basis? This is a ''HUGE'' red flag. ''']''' <sup>]</sup> 15:30, 26 March 2007 (UTC) | |||
| :Wow, I didn't notice that - good point! The survey is even more ridiculous than I thought. -] 05:23, 27 March 2007 (UTC) | |||
| ==References in criticism section== | |||
| Because of the obvious threat of POV in the criticisms section, the references there need to be solid and reputable. Whenever possible, references should be to PEER-REVIEWED, PUBLISHED WORK when referencing an original argument in the area of economics or medicine. At the very least, such references should be made to a PRIMARY WORK which describes its METHODOLOGY. I have removed one reference to the "dug cost" section which pointed to a "popular press" type account put out by a libertarian organization which cited an oral presentation in which a "research scientist" argued that "80% of modern drug prices" are due to certain FDA regulations. I find this to be an extraordinary claim requiring extraordinary evidence & detailed methodology on how that number was calculated. Instead, we have a secondhand account of an oral presentation by a person with no economics training who (as far as I can tell and I did an extensive search) never published her medical "economics" work in a peer-reviewed setting. She appears to have done some lab-based research on liver disease up until the early 1990's, and became a politially active Libertarian when her pet theory that adding hormones to alcoholic beverages would prevent liver disease was deemed to be unfeasible. Dude, your references need to be better than this. | |||
| Also, if one is going to quote "nobel prize winning economists" a formal economics paper (I assume they published a few) would be a better reference than a magazine editorial with no methodology or references. | |||
| -] 05:48, 24 March 2007 (UTC) | |||
| :If you're talking about Becker, that's not something that can be measured by an economics study. What he's saying is that prior to 1962, only safety was required to be proved to the FDA. After the 1962 regulations, they started requiring proof of efficicacy as well. His recommends that those regulations be eliminated in order to lower prices. His opinion is that it's not worth the extra cost just to make sure the drugs do what they say the do. If drugs are falsely advertised, drug companies can already be sued. There is no one that would dispute that eliminating those regulations would lower drug prices. That's obvious. ] 18:27, 24 March 2007 (UTC) | |||
| ::Reg, there is a reason this doesn't make sense to those of us who are actually in medicine. All drugs have side effects. Some are worse than others and many widely used drugs have very common mild side effects or rare severe or even fatal side effects. The FDA approves drugs based on whether the benefit to a patient for at least one indication outweighs the potential harm caused by the drug. You can't consider safety and efficacy in isolation - if we only considered safety, no chemotherapy drug would ever be approved because they are incredibly unsafe. They are approved because their efficacy at fighting a deadly disease outweighs the huge risks they pose to patients. Only a person who knows NOTHING about medicine could claim that the FDA should simply set a "minimum safety standard for all drugs". Saying we could use pre-1962 regulations for the modern drug era is like saying we should eliminate air traffic controllers because back in the 1800's they didn't exist and hot air balloons hardly ever ran into one another. Most of your arguments are either wildly out of date or use highly dubious sources. | |||
| ::Also I will continue to delete comments like "so-and-so thinks the FDA should be eliminated." It is pure POV and irrelevant. An acceptable comment might be "so-and-so demonstrated through the following referenced analysis (from sometime this century) that elimination of the FDA's drug approval powers would be likely to lower drug prices by 80%." The reader could then READ that analysis for themselves and decide whether that figure is supported or just pulled out of someone's hiney. | |||
| ::--] 04:20, 25 March 2007 (UTC) | |||
| I'm deleting "Public Citizen suggests that the actual cost is under $200 million, about 29% of which is spent on FDA-required clinical trials." Who is Public Citizen? There is no name of the person making these claims on that webs site. That can't be a credible source by any standard. ] 18:12, 24 March 2007 (UTC) | |||
| :Come on now. ] is a well-known consumer advocacy group founded by Ralph Nader. If you're not sure who they are, before deleting the sourced information Google them or read the Misplaced Pages article. What they have to say is at least as notable, if not far more so, than 99% of the critics quoted. I'm going to ] that you deleted that information in good faith, not realizing this; Public Citizen is a ] for this sort of thing, so I'll restore it now. ''']''' <sup>]</sup> 00:27, 25 March 2007 (UTC) | |||
| ::I think Reg is responding to my insistance that we reference only sources which fully describe their methodology. The previous ref was to a page on the Public Citizen website which responded to Dimasi's 2003 research. It does explain its methodology, but not in a detailed or formal manner. The reason is that PC had issued a full-length report on this issue (yes, with authors listed, Reg) in 2001, and they merely reapplied that same methodology to criticise Dimasi's new paper. I've added a ref linking to the full 2001 report. | |||
| ::-] 07:08, 25 March 2007 (UTC) | |||
| :I agree, MastCell. I redacted the crit section again. I agree that the stuff from the think tanks and magazines are garbage. That stuff is just not criticism that matters. The OTC regulation is a non-issue. If people have specific problems with the FDA, they need to write their congressman.--] 05:16, 25 March 2007 (UTC) | |||
| :Maybe the cost of drug development deserves its own article--why would someone look in the FDA article to read a discussion of the different estimates of drug costs. As we are finding with our research, there are at least three numbers--that probably can be the basis of a new article...--] 05:16, 25 March 2007 (UTC) | |||
| ==Safety and Efficacy== | |||
| First, I did not "delete Becker's main argument" because you had already made it in the previous paragraph - you simply repeated it at the end of the entry so that you would have the last word. | |||
| As I have written before, and you have not responded to, the idea of eliminating the "efficacy" testing without eliminating the "safety" testing revels ignorance of the purpose of the three phases of clinical testing. ALL THREE phases (and often post-market survalliance) are required to ensure drug safety. The small phase one trials do not establish that a drug is "safe" because they only have the power to detect very common and/or unusual side effects. All they establish is that the drug is safe enough to proceed to the next phase of testing - ditto for safety testing in phase II. I've rephrased your entry a bit to address this reality. | |||
| Second, there is no such thing as evaluating "safety" in isolation in the current system. Drugs are evaluated based on their safety relative to the benefit they bring to patients (i.e. their efficacy). We tolerate much worse side effects in chemotherapy drugs (which may be effective in saving someone's life) than we do in anti-impotence drugs, for example. Unless you can provide a reference which explains what Becker is actually suggesting in a way that makes sense to the medical professional contributors to this page, we will likely continue to trim your material. | |||
| --] 23:22, 26 March 2007 (UTC) | |||
| :We will likely trim your material in return, until you get a grasp on what Becker is saying. ] 00:28, 27 March 2007 (UTC) | |||
| ::What part of the above comments demonstrate a "failure to grasp?" I am still waiting for an explanation and a reference containing some semblance of methodology.-] 01:07, 27 March 2007 (UTC) | |||
| :::What don't you understand? He simply recommends eliminating the regulations that require proof of efficacy to the FDA. This makes drugs cheaper to bring to market, resulting in more drugs being brought to market. The more drugs, the more competition. The more competition, the lower the prices. Prior to 1962, efficacy needed not be proved. He advocates rolling back all the regulations introduced by the Kefauver-Harris Amendment. ] 01:13, 27 March 2007 (UTC) | |||
| ::::How many times do I have to repeat this? A "safe" drug as evaluated by the FDA is one for which the "risks do not outweigh the benefits." Efficacy testing is inseparable from safety testing. There are not separate "efficacy trials" that could be eliminated - pivotal phase III trials are the most important part of safety testing. So either you are suggesting much lower (and arbitrary) safety standards, or the "repeal of the Kefauver-Harris Amendment" would have no effect. Choose one, and PROVIDE A BETTER REFERENCE. -] 01:43, 27 March 2007 (UTC) | |||
| :::::Prior to 1962, there was no proof of efficacy requirement. Becker advocates eliminating all of the regulations introduced by Kefauver-Harris, along with any safety regulations that were included in that. What's so hard to understand? Do you deny that there was no requirement for proof of efficacy prior to 1962. What are you trying to say? ] 01:48, 27 March 2007 (UTC) | |||
| ::::::Your (and Becker's) obsession with 1962 is the problem. "Safety" and "efficacy" are not defined by the medical community (the standard used by the act) in the same way they were in 1962. To modern medical professionals, the concept of a "safe drug" has no meaning in isolation from efficacy. The concept of safety is inseparably tied to efficacy, because "safety" is a balance of the risks and benefits of a drug. See . I am sorry if I have not made this clear in my previous five posts on this topic(although you might want to read back if you just skipped them). -] 02:20, 27 March 2007 (UTC) | |||
| :::::::Regardless of how you define safety, prior to 1962 efficacy was not taken into account in the equation. ] 02:33, 27 March 2007 (UTC) | |||
| ::::::::Thank you for the irrelevant historical fact. You know, the History section in this article could use some work. -] 02:37, 27 March 2007 (UTC) | |||
| :::::::::It's very relevant. It's the point. By requiring that efficacy be taken into account when determining whether the FDA thinks something is safe, it increased the costs of bringing drugs to market. ] 02:39, 27 March 2007 (UTC) | |||
| ::::::::::If the word "efficacy" was struck from every FDA authorizing statute tomorrow, they would still require proof of efficacy in order to evaluate safety, because that is part of the accepted definiation of safety by modern medical experts. -] 02:48, 27 March 2007 (UTC) | |||
| :::::::::::Not prior to 1962. ] 18:54, 27 March 2007 (UTC) | |||
| :For what it's worth, safety and efficacy are completely different things. Safety and efficacy have strictly defined meanings, and one great thing the Kefauver-Harris Amendment did was to legislate the definition of efficacy, with input from the nascent science of pharmacology. --] 01:21, 29 March 2007 (UTC) | |||
| ==DiMasi== | |||
| What kind of idiocy is this, from DiMasi? "At the time that drug prices are determined, the associated R&D spending for a drug is a sunk cost. Basic economic logic tells us that R&D costs do not determine prices." Doesn't he realize that that the cost won't be "sunk" in the first place unless it is projected that the investment can be recouped ...unless it is projected that there a market for a high priced drug? If it's cheaper to bring that same drug to market then a lower price can be charged, and, quite possibly, therefore higher profits. It's as if he thinks higher prices = higher profits. That is not the case unless demand is inelastic, which it is not. It is often more profitable to charge a lower prices than a higher price. And, of course, he ignores competitive pressures. If you can bring a drug to market for a lower cost, then you are able to better compete against other drugs, which can institute a price war. It's hard to belief that DiMasi is an economist. ] 02:26, 27 March 2007 (UTC) | |||
| :"If it's cheaper to bring that same drug to market then a lower price can be charged, and, quite possibly, therefore higher profits." No, this is flat wrong. The price which maximises profits (sales X price - production costs) is independant of the cost of development. You point about competition would make sense if pharmaceuticals operated anything like a perfect market, but it doesn't - the reasons for this are complex & controversial - you can exchange angry letters with DiMasi if you want details. By the way, I'm still waiting for a real published reference from any of the economists you are fond of quoting. -] 02:44, 27 March 2007 (UTC) | |||
| ::Yes the price which maximizes profit is independent of the cost of development, but the cost of development won't be taken unless it is projected that the cost can be recouped ..unless it is projected that there is a market for a high priced drug. If there is not such a projection, then the costs won't be expended. Let's say for example, that the profit maximizing price is $1/pill. If they cannot charge that low of price but charge a higher price and still be profitable, then they will expend the investment and charge higher than $1/pill. If the same drug can be produced for a lower cost, because of the elimination of coercive regulation, such that they can actually charge $1/pill and be profitable then that's what they'll do because that is the profit maximizing price. There is a direct relation between prices charged and costs of investment. ] 02:54, 27 March 2007 (UTC) | |||
| :::This doesn't make any sense. How could the drug be unprofitable at the profit maximizing price, but be profitable at a higher price? The definition of a "profit maximizing price" is that any price - higher or lower - is less profitable. Seems pretty clear to me. Either they can make an net positive profit at the profit maximizing price or they can't - as you say, if they know in advance that the latter will be the case, then they will not develop the drug, but the price of the drug if they do develop it will be no different (the "profit maximimizing price" could still result in a negative profit - it would just be the smallest possible loss.)-] 03:13, 27 March 2007 (UTC) | |||
| ::::You can make a profit selling at a higher price, even though selling at a lower price will reap more profit. Understand? Beginning at some point, the higher price you charge the more customers you start losing. There is some price X which maximizes profit, above which starts eroding profit and below which starts eroding profit. Let's say X +10 is the price where you will have zero customers. You will make any investment that will allow you to sell your drugs at any price from X all the way up to X+9. If the costs to you are so great that you can only charge greater than X, but less than X+10, then you will invest and sell at a price greater than X. If the costs to you are low enough that you can charge X, then you will invest and charge X. ] 03:24, 27 March 2007 (UTC) | |||
| :::::You are digging yourself deeper into a hole of noncomprehension. Let's spell out a simplified example. A drug company calculates that the profit maximizing price of the drug is $20 per dose, and at that price, they will sell 10 million doses over the lifetime of the drug for net proceeds of $200 million - since it costs $5 per dose to make the drug, their profit (not counting development costs) at the profit maximizing price is $150 million. If they raise the price to 21 dollars, they will only sell 9 million doses (people are priced out) so their profit would be only $144. If they lower the price to $19 dollars, they will only sell a few more doses, and will also end up with a lower profit. That's why $20 is the "profit maximizing price." And that is what they will charge, however much we as consumers might want them to set a lower price. So far so good? | |||
| :::::First let's say the development costs for the drug are $100 million. They'll change the PMP and make an overall net profit of $50 million. Now let's say an evil regulatory agency makes them do more tests and development costs $200 million. In this case, at the PMP, they will lose $50 million. If they know this and have not yet "sunk" the development costs, they will simply not make the drug. If they HAVE already "sunk" $100 million in development costs, they WILL develop the drug because their future development costs ($100 million) are less than their future profits ($150 million) - so they will be out a total of $50 million instead of $100 million if they chose to abandon the drug. If they have already sunk $200 million, again they will still sell the drug at the profit maximizing price for a net loss overall of the same $50 million. In NO CASE would it help them to change the price of the drug because our earlier calculation is unaffected by the development costs - raising the price to $21 would give them an even greater loss ($56 million) than at the PMP. | |||
| :::::Repeat after me: "Development costs do not affect the profit maximizing price, and companies will ALWAYS charge the profit maximizing price if they decide to make the product at all." -] 03:59, 27 March 2007 (UTC) | |||
| :::::On reading your re-write of your latest post, you seem to be under the mistaken impression that companies charge the lowest price that makes them profitable. This is not what companies do. They charge the price which yields MAXIMUM profits. No company ever charged a lower price just because they "could". -] 04:07, 27 March 2007 (UTC) | |||
| ::::::And, the price that yields maximum profit is lower than other prices it can charge and still profit but profit less. That's what you're missing. The lower the investment, the more profitable they can be, because they can charge that lower price. The investment is not "sunk" until it is made. A company has to make a profit. It won't make that investment unless it can profit. And, it will make that investment even if it can't reap maximum profit (which would come from charging a lower price than a higher price). ] 17:47, 27 March 2007 (UTC) | |||
| While these are interesting issues, Misplaced Pages talk pages are ]. Let's bring it back to concrete examples of what we'd like the article to say. ''']''' <sup>]</sup> 17:11, 27 March 2007 (UTC) | |||
| ==Example of an authoritative reference == | |||
| Here Ref, why don't you try replacing some of your shaky references with info from this GAO report: . Note how it is a formal report and not a popular press opinion column. Also note how it explains its methodology and cites its sources. Go to town. -] 07:49, 27 March 2007 (UTC) | |||
| :And we ''could'' always consider citing the peer-reviewed medical literature (e.g. PMID 11268222), which suggests most people would prefer ''increasing'' FDA regulation of things like dietary supplements, rather than decreasing regulation of prescription drugs. Or an ] survey also for increasing the FDA's regulatory mandate (note the methodology of the poll sampling is spelled out). Or a nationwide Harris poll (no disrespect to The Polling Company) finding that most people that the FDA was looking out for them, even when it's not (see "Drugs vs. Supplements"). In the interest of ] and avoiding undue weight and all. ''']''' <sup>]</sup> 16:46, 27 March 2007 (UTC) | |||
| == Let's move criticism section to separate article == | |||
| It is getting way too big on this article and dwarfs just the basic information that this article should provide about the agency. Any thoughts? ] 19:13, 27 March 2007 (UTC) | |||
| :Sure. Let's just make one small section about criticisms and then point out that the main article is "Criticisms of the FDA". I'm getting tired of people deleting information under the pretense that we're running out space. ] 19:14, 27 March 2007 (UTC) | |||
| ::The problem is not "space". The problem is the ] (see ]) which is being given to criticism (particularly certain criticisms) of the FDA. Realistically, the FDA is not criticized heavily enough to warrant its own ] (unless one includes every Ph.D thesis and libertarian newsletter out there), and such a move would greenlight and exacerbate the problems we're having with ]. Criticisms could ''easily'' be summarized without dwarfing the article if we applied ] and ]. See my suggested summary of the "Criticism of overregulation" section above. ''']''' <sup>]</sup> 19:32, 27 March 2007 (UTC) | |||
| :::Looks like we will just have to agree to disagree here. I think there is a vast amount of fair criticism of FDA from both those that want more regulations and those that want less. I'm not saying I agree with it all, but I can understand their criticisms of the agency. How does everyone else feel about creating a fork? ] 19:52, 27 March 2007 (UTC) | |||
| ::::I've disagreed with that suggestion in the past. I agree with you that there are very important controversies about the FDA, and I think they are too important to be sidetracked on a separate page, which I suspect will be plagued by poor quality references and ]. I think nearly all of the sections in the current criticism section represent real and important issues which should be addressed, but I think that some of them are focused on very extreme or poorly referenced viewpoints, rather than on the mainstream debate which is ongoing among policymakers and in the academic literature. I'm going to hold off on editing the main page criticism section for a while, and I suggest we make one more concerted effort on the talk page to decide what does and does not belong in the criticism section - perhaps each contributor could write a summary of the topic headings and refereces which they believe should be used. Hopefully we can find a way to construct it so that the major controversies affecting the future of the FDA are all represented. I also think this page would be greatly enhanced by a proper history section. -] 21:14, 27 March 2007 (UTC) | |||
| :::"Realistically, the FDA is not criticized heavily enough to warrant its own.." You can't be serious. The FDA is constantly under attack from all directions. ] 02:05, 28 March 2007 (UTC) | |||
| ::::Could you at least hold off on adding MORE silliness until we've had a chance to agree on a plan on the talk page? I mean, "The Freeman"? Seriously? I guess next we'll need quotes from the Comintern to 'balance' it.-] 02:20, 28 March 2007 (UTC) | |||
| :::::I recall you insisting on keeping input from "The Public Citizen" website by an unamed writer even. The Freeman is a peer reviewed publication, and the author, Daniel B. Klein, is a professor of economics. ] 02:25, 28 March 2007 (UTC) | |||
| ::::::You recall wrong. I didn't add the Public citizen webpage you're referring to, and I agreed with you that it was not an adequate reference on its own. That's why I found the full Public Citizen report to which it referred, with methodology, references and authors, and I linked to it. If I had not found that report, I would have removed the public citizen piece entirely. The Freeman is an idological publication, not a peer-reviewed academic journal. -] 19:56, 28 March 2007 (UTC) | |||
| ::::::From the publishers of The Freeman: "Our flagship publication, The Freeman: Ideas on Liberty, is one of the oldest and most respected journals of liberty in America. For almost 50 years it has uncompromisingly defended the ideals of the free society. Through its articles, commentaries and book reviews, several generations of Americans have also learned the consequences and contradictions that inevitably result from collectivism, interventionism, and the welfare state." Sounds like an idological/advocacy publication to me. -] 20:37, 28 March 2007 (UTC) | |||
| False equivalence. "Many believe..." are ] that, rather than being removed, are . As far as the volume of criticism, the ] receives far more mainstream, notable criticism than the FDA, yet somehow the article manages to do without a separate "criticism of DHS" sub-article (Katrina aside). Basically, the good sources need to be separated from the non-noteworthy, and then the length issues will fall into place. Milton Friedman and Gary Becker are notable. The ''Ayn Rand Weekly Newsletter'' isn't. ''']''' <sup>]</sup> 03:34, 28 March 2007 (UTC) | |||
| :Laissez-faire economics is mainstream in academia. The de-regulation mindset is the status quo. ] 03:36, 28 March 2007 (UTC) | |||
| :This is interesting. Economist Daniel B. Klein says: "Although one can occasionally find remarks by economists vaguely favoring government restrictions on health products, those are not the economists who have written on the FDA or provided serious argumentation.3 I have tried to survey all economists’ writings on the FDA and have not been able to find a single instance of an economist defending the contemporary FDA or advocating tighter restrictions. Contrary to the joke about laying all the economists end to end, those who study the issue do reach a conclusion: Relax restrictions on drugs and devices." ] 03:47, 28 March 2007 (UTC) | |||
| ::I'm sorry, but the idea that the FDA should be abolished, or its powers dramatically curtailed, is ''not'' mainstream anywhere. If it were, you'd be able to provide better references. But instead, we get the ] (source of the above quote claiming all economists agree) and the ]. Again, the lack of ''good quality'' sources is a clear indication that these views are not mainstream. ''']''' <sup>]</sup> 03:53, 28 March 2007 (UTC) | |||
| :::What do you mean they're not good quality sources? Just because someone has a POV it doesn't mean they're not a quality source. You have to have a POV in order to be critical of the FDA. ] 04:10, 28 March 2007 (UTC) If you'll notice, also, I've been supplying studies as well. Believe me, there is a lot more to come. ] 04:11, 28 March 2007 (UTC) | |||
| Let's try to keep this particular area focused on one question: Do we want to create a fork for the criticism section or not. For all other disagreements please create a new section. I would argue we should have a fork for the following reasons: (1) the criticism section tends to be one of the longest parts of the article and dwarfs the other relevant information about the agency which would typically be found for an encyclopedic description of the agency and (2) it is the part of the article that is by far the most contentious and the most like to be tagged with clean-up notices, NPOV notices, and other such notices that make readers discount the value of the whole article. If we could break this part off from the main article, we would be able to focus this page on being as high quality as possible for a general description of the FDA while still being able to fully debate the other issues that constantly assail the FDA on a separate page. Other thoughts? ] 12:24, 28 March 2007 (UTC) | |||
| :Yes let's create a new article. There is way too much information out there that has to do with FDA criticism to fit in a small space. ] 16:29, 28 March 2007 (UTC) | |||
| ===Voting area=== | |||
| This vote is not intended to be definative, but just illuminate what everyone's opinions are in a concise fashion. ] 17:24, 28 March 2007 (UTC) | |||
| * '''Support'''- I support creating a fork from the main FDA page to create a separate page exclusively to discuss FDA criticism. ] 20:39, 28 March 2007 (UTC) | |||
| * '''Oppose''' as above. Criticism can fit here if we apply ]. ''']''' <sup>]</sup> 17:56, 28 March 2007 (UTC) | |||
| * '''Support''' But I don't think we need majority rule to create the new article. We can just do it. It doesn't harm this article in any way. And I think that those oppose it are simply pro-government people who just don't want all the criticism out there to be revealed. So they make the excuse that there's not enough space and delete information. ] 18:10, 28 March 2007 (UTC) | |||
| ::Uh, it would be best if you at least made an effort to reach ] before creating the content fork. ] of other editors and ] doesn't advance that goal. ''']''' <sup>]</sup> 20:21, 28 March 2007 (UTC) | |||
| * '''Support''' - OK, I give up in the interest of reaching some stability. However, I think we should retain a section in the main page, titled "FDA reform", to discuss recent and ongoing events in FDA policymaking, such as court cases (e.g. the Abigail Burroughs case), active & pending legislation, ongoing and recent FDA policy reviews, congressional or presidential commissions & reports, official changes in FDA policy, etc. This would include some of the items currently in the criticism section, but they would be presented as "current events" rather than ideological arguments. This should follow a full and strictly objective "FDA history" section. Also, some items in the criticism section, such as scholarly estimates of the current cost of drug development could be placed (without editorial comment) in appropriate sections of the main article.-] 20:28, 28 March 2007 (UTC) | |||
| : I like this suggestion. ] 20:40, 28 March 2007 (UTC) | |||
| ==Deletion of studies by MastCell== | |||
| So, it was complained by MastCell and Rustavo that I'm not supplying studies from peer-review journals. However, when I add them to the article MastCell deletes them. He says he's doing this because I'm not allowed to interpret them and that I'm doing "original research." Sorry but there is no rule on Misplaced Pages that say sources have to be secondary sources. ] 03:45, 29 March 2007 (UTC) | |||
| :Actually, there is. It's ]. It's all worth reading, but I'll quote the following: ''"Misplaced Pages articles should rely on reliable, published secondary sources wherever possible. This means that we only publish the opinions of reliable authors, and not the opinions of Wikipedians who have read and interpreted primary source material for themselves."'' I don't make this stuff up. ''']''' <sup>]</sup> 03:47, 29 March 2007 (UTC) | |||
| ::You may not make it up, but you choose to refer to a "guideline" rather than official policy. ], which is official policy, says "All articles on Misplaced Pages should be based on information collected from published primary and secondary sources. This is not "original research"; it is "source-based research", and it is fundamental to writing an encyclopedia. Although most articles should rely predominantly on secondary sources, there are rare occasions when they may rely entirely on primary sources (for example, current events or legal cases). An article or section of an article that relies on a primary source should (1) only make descriptive claims, the accuracy of which is easily verifiable by any reasonable, educated person without specialist knowledge, and (2) make no analytic, synthetic, interpretive, explanatory, or evaluative claims. Contributors drawing on entirely primary sources should be careful to comply with both conditions." This is definitely an article which may rely on many primary sources, that is, studies. ] 03:51, 29 March 2007 (UTC) | |||
| :::This is just another version of the ongoing debate about what constitutes a quality source. Primary sources are great, but they need to be appropriate ones - if we're making a point in medicine and economics, we should be looking for widely cited articles in the mainstream scholarly medical or economics literature. Your sources continue to be either informal, unreferenced "op-ed" columns or articles from obscure ideological journals which are not widely cited by mainstream academics or policymakers. And you often feel the need to write out the entire arguement of said articles, often with your own ideological elaboration, rather than composing a concise statement and referring the reader to your source for more details. You have tried to use informal quotes from two "Nobel Prize-winning Economists" - but when these kinds of guys want to make a serious argument in an area of their expertise, they do it in a well-referenced article in a mainstream economics journal, which allows their peers (and us!) to formally evaluate and build on their work. What I find most frustrating is that I am sure there are referenced, academic papers which contain some of the same points you are proposing, albeit in more formal and nuanced form. I wish you would take the time to find them rather than continually drawing from libertarian think-tank position papers and the like. -] 06:17, 29 March 2007 (UTC) | |||
| :::::That's not what we're talking about. We're talking about actual studies that I'm inserting and MastCell is deleting such as Wang H, Nair MG, Strasburg GM, et al. Antioxidant and antiinflammatory activities of anthocyanins and their aglycon, cyanidin, from tart cherries. J Nat Prod. 1999 Feb;62(2):294-6., Seeram NP, Momin RA, Nair MG, Bourquin LD. Cyclooxygenase inhibitory and antioxidant cyanidin glycosides in cherries and berries. Phytomedicine. 2001 Sep;8(5):362-9, and Seeram NP, Zhang Y, Nair MG. Inhibition of proliferation of human cancer cells and cyclooxygenase enzymes by anthocyanidins and catechins. Nutr Cancer. 2003;46(1):101 which show that the health claims for cherries in the examples in the article are true. These are studies in peer-reviewed journals. You guys say you want studies, but then when I put them in the article MastCell deletes them with the reason that they're primary sources. ] 14:55, 29 March 2007 (UTC) | |||
| No. Those studies show that some chemicals in cherries are effective in laboratory models of inflammation or cancer. They don't show that cherries "ease the pain of arthritis without side effects" or "flush cancer cells out of the body". What you're doing is like saying, "Some bread molds contain penicillins.(reference) Therefore, science shows that eating moldy bread can cure bacterial infections - only the FDA is too obtuse to let bread manufacturers claim that." Do you see the interpretive leap you're making from the primary sources? Those primary sources say nothing about the FDA or regulation, yet you're employing them to make the case that the FDA overregulates in a way that ignores science - a textbook violation of ] and ]. By the way, "guideline" doesn't mean follow when convenient. It means it should be followed ''unless'' you can make a convincing argument that this is one of the very few cases where we should disregard it. ''']''' <sup>]</sup> 15:05, 29 March 2007 (UTC) | |||
| :So now you acknowledge that primary sources can be used. If the article points out examples of claims that cherry sellers are making then it makes sense to provide evidence of whether the claims are true or not, to show their not just making this up. I'm going to go through these one at a time, to avoid confusion: One of the claims the article gives an example of is "If you're plagued with chronic pain of arthritis, headaches, or even gout, pros say a daily bowl of cherries COULD ease your ache without side effects." Ok, here's a study: Tall JM, Seeram NP, Zhao C, et al. Tart cherry anthocyanins suppress inflammation-induced pain behavior in rats. Behav Brain Res. 2004 Aug 12;153(1):181-8. The pain from arthritis, headaches, and gout comes from inflammation. Here is another study about the anti-inflamatory effect of cherries: Wang H, Nair MG, Strasburg GM, et al. Antioxidant and antinflammatory activities of anthocyanins and their aglycon, cyanidin, from tart cherries. J Nat Prod. 1999 Feb;62(2):294-6. Here is another study: Kelley, D.S., et al. 2006. Consumption of Bing sweet cherries lowers circulating concentrations of inflammation markers in healthy men and women. Journal of Nutrition 136(April):981-986. "Are you going to delete these studies if I insert them to show that there is evidence of the claim? If so, why? (If there is evidence that it may work, then what's the harm of notifying customers of this so people in pain can give it a try? If it doesn't help relieve the pain and inflammation for everybody, then at least they ate something healthy. This is the kind of destructive censorship that the FDA engages in. And, Allah willing, this prior retraint on speech will eventually be found unconstitutional and we can add the ruling to the history section.). ] 15:23, 29 March 2007 (UTC) | |||
| ::Primary sources are fine, but your citations do not provide evidence for the things you and the cherry manufacturers attribute to them. None of the studies you cite were designed to demonstrate efficacy of cherries at treating human disease. The authors of these studies do not make these sorts of claims. Did you actually read the full studies, or did you just see them referenced at a libertarian site, so you linked to the abstracts? -] 20:21, 29 March 2007 (UTC) | |||
| :::Exactly. Primary sources are acceptable ''so long as you stick to what is in the source'' and don't draw your own interpretations or conclusions. Which is what you did. This is actually all spelled out in ] and ] and might be worth looking at again. ''']''' <sup>]</sup> 20:28, 29 March 2007 (UTC) | |||
| :::Did you even bother to read the abstracts? I quote from the first study I listed: "The use of complementary and alternative medicine (CAM) has increased in the United States and more patients are seeking CAM therapies for control of pain...These data suggest that tart cherry anthocyanins may have a beneficial role in the treatment of inflammatory pain." Or how about the third one: "Healthy men and women (n = 18) supplemented their diets with Bing sweet cherries (280 g/d) for 28 d. Cherry consumption...study suggest a selective modulatory effect of sweet cherries on CRP, NO, and RANTES. Such anti-inflammatory effects may be beneficial for the management and prevention of inflammatory diseases." That is consistent with the claim that "a daily bowl of cherries COULD ease your ache without side effects." ] 20:32, 29 March 2007 (UTC) | |||
| ::::I read the abstracts and full conclusions of the studies, and skimmed the rest. Here's the pithy summary of the findings from the first: "The present studies demonstrate that anthocyanins extracted from tart cherries reduced inflammation-induced thermal and mechanical hyperalgesia in rats." So a concentrated chemical extracted from cherries appeared to reduce rat pain in an experimental model of inflammation. No data using whole cherries or cherry juice. No data from humans. No data concerning headaches, arthritis, or gout. They authors engage in speculation (clearly identified as such) at the end of the article about what future research might show. The other study you quote was done with cherries, in humans, but did not look at pain, gout, headaches, or arthritis. A few decreases were seen in the levels of immune system hormones, which "might" mean that cherries fight inflammation, it "might" mean that the patients' immune systems were supressed, it "might" have been an artifact of several limitations of the study which the authors discuss at length, and it "might" mean nothing significant at all for their health. Both studies conclude by saying that further research is warranted and neither reccomends the use of cherries for the treatment of human disease on the basis of their results. It is generally preferable to quote from the text of a study rather than from the abstract, which is condensed and simplified - this has the added benefit of demonstrating that you actually read the study.-] 21:19, 29 March 2007 (UTC) | |||
| ::::::"Might, yes." And, the claim from the cherry provider is "could." That generally means the same thing. ] 23:06, 29 March 2007 (UTC) | |||
| Those sources say nothing about the regulation of cherries or the FDA. You need a source making the connection between those studies and the FDA's regulation of cherries. You're reading those studies and saying, "based on these data, the FDA is out of line." That's ] and your opinion. Just provide a published, ] source indicating that they think the FDA is overregulating or out of step with the science of cherries, and it can go back in. ''']''' <sup>]</sup> 20:49, 29 March 2007 (UTC) | |||
| :I never stated in the article that the FDA was out of line. I merely noted that there was evidence that cherries may be beneficial in those ways. I don't need a source that says the FDA is overregulating the cherries, since that claim is not being made. ] 23:06, 29 March 2007 (UTC) | |||
| ::Come on. You wrote that the FDA stance "flies in the face" of the scientific evidence; the implication is clear. If your primary sources make no mention of the FDA or its regulatory capacity, and don't criticize the FDA, and you don't have any secondary sources making such a link, then they're inappropriate for this article. They might be more apropos at ]. ''']''' <sup>]</sup> 23:14, 29 March 2007 (UTC) | |||
| :::Don't misquote me. I did not say "flies in the face." I said "This is in the face of.." All the sources quoted in this criticism section of this article don't need to be criticisms of the FDA. Some can simply be informational. ] 23:31, 29 March 2007 (UTC) | |||
| ::::You're correct about the exact phrasing, although it does not alter my point in any way. All of the information in the "Criticism of the FDA" section should be criticism of the FDA. "Informational" resources about cherries should go in the ] article. ''']''' <sup>]</sup> 23:44, 29 March 2007 (UTC) | |||
| :::::Absolutely not. If the information is related to the criticism of the FDA then it should be in this article. ] 02:48, 30 March 2007 (UTC) | |||
| Sigh. The problem is that ''you'' decided that the cherry articles are related to the FDA, because it fits in with ''your'' personal viewpoint and a point you'd like to make. The authors don't mention the FDA. That's ] and a textbook violation of Misplaced Pages's policies. If you don't get why it's a problem, maybe we should get some outside opinions. ''']''' <sup>]</sup> 04:27, 30 March 2007 (UTC) | |||
| ==History section== | |||
| OK, part one of the new history section is up - I'll add content up to the present over the next week or so. My sources at this point are mostly from documents on the FDA website, although I'll also be looking for corroborating sources as time goes on - I look forward to seeing others' contributions. Let's try to keep this section as objective and NPOV as possible. Also, I'll leave blind hyperlinks in for now - we can either add the new pages or delink them as appropriate as things come together.-] 06:27, 29 March 2007 (UTC) | |||
| == Off-label use == | |||
| I don't quite understand this paragraph: | |||
| <blockquote>For example, the drug propranolol was approved for limited use in 1968 but not allowed to be used for angina or hypertion, until it was approved for angina in 1973 and approved for hypertension in 1976. A study by Arthur D. Little estimated that approximately 10,000 American died every year that the FDA prohibited doctors from treating their patients with it.</blockquote> | |||
| If the FDA approved propranolol, then it could be used off-label for angina or hypertension at the discretion of any practicing physician. The FDA can't "prohibit" doctors from using an approved drug off-label - they can only prevent drug makers from advertising and promoting an off-label use (which may be why the source here, PhRMA, was so upset). Propranolol was actually in active trials for angina from the moment it gained "limited" approval (see PMID 787954, PMID 816188). As soon as the results of those trials became available, it gained expanded approval - although again, any doctor could have used it for angina earlier if he/she felt it was appropriate, and they were not "prohibited" by the FDA from doing so. Sure, if we had psychic powers in 1968 and could have predicted that the angina trials would show benefit, propranolol could have been approved on the spot. ''']''' <sup>]</sup> 15:31, 30 March 2007 (UTC) | |||
| :Point taken. The wording was not accurate. I'll change simply "prohibit" to "prohibit advertising and promoting." That prevented people from knowing about and therefore requesting the drug that could save their lives. If the drug was already said to be safe by the FDA then what is the point of preventing people from having information that may save their lives? Shouldn't the individual himself be allowed to make the decision whether the potential rewards of the drug saving his life is worth the risk of it being non-effective though safe? You're right that the FDA does not have psychic powers. It doesn't have the power to know what level of risk that any given individual is willing to take. It overrides individual decisions-making and people die unnecessarily as a result. This is a whole new criticism that can be added to this article. ] 15:50, 30 March 2007 (UTC) | |||
| ::But people weren't prevented from knowing about it, the company was just prohibited from advertising its drugs as being effective for this indication. Doctors could freely discuss this information among themselves and others can freely disseminate this information, which is protected under free speech of the first amendment (which I believe is specifically talked about in the Washington Legal Foundation cases). ] 16:07, 30 March 2007 (UTC) | |||
| :::Manufacturers were prevented from telling doctors about it. They were prevented even from sending peer-reviewed studies to the doctors. These leaves not only patients but doctors in the dark as well. Yes the Washington Legal Foundation case loosened a lot of restrictions. This was on appeal by the FDA fighting the loosening of the restrictions on speech. The FDA fights at every turn to retain and/or increase it's powers. ] 16:23, 30 March 2007 (UTC) | |||
| Doctors are responsible for, and generally capable of, keeping up with the peer-reviewed literature on their own - without the help of kindly, totally altrustic and unbiased drug companies sending them literature. Yes, manufacturers are prohibited from claiming efficacy which has not been proven - this is a "restriction" of free speech which has wide acceptance in the form of false-advertising and consumer-fraud legislation. ''']''' <sup>]</sup> 17:09, 30 March 2007 (UTC) | |||
| :Doctors cannot keep up with all the information that's out there. Studies need to be sent to them so they can make an informed decision. There are loads of drugs that doctors don't know about that can help their patients. False advertising is already illegal and always will be. This is not a matter of false advertising. I suppose you want to reverse the 2000 court case that allowed greater dissemination of information because the FDA's censorship was found unconstitutional, which the FDA fought. Do you work for the FDA? ] 17:16, 30 March 2007 (UTC) | |||
| ::Pharmaceutical companies are not a good source of unbiased medical information. You're saying that drug companies should have been able to claim benefits from propranolol before those benefits were proven to exist. What is that if not false advertising? If physicians were convinced benefits existed even before the studies were completed, then they had the latitude to prescribe propranolol based on their invididual judgement. I don't see a horribly broken system here. No, I don't work for the FDA (and such questions are a bit ]) - I'm ambivalent about it and think there are many valid criticisms of it, especially in terms of its political susceptibility (e.g. Plan B ]). I just don't like seeing this Misplaced Pages article used ] to uncritically rehash a bunch of fringe criticisms in a way that violates ]. ''']''' <sup>]</sup> 17:32, 30 March 2007 (UTC) | |||
| :::You think doctors are too stupid to consider the source? You're insulting doctors. I don't know of any doctor that believes that the government should prevent information and studies about drugs, that could help their patients, from being sent to them, regardless of who's sending them. You've got this pro Big Brother mentality that is offputting. I am not "saying that drug companies should have been able to claim benefits from propranolol before those benefits were proven to exist." I am saying they should be allowed to send peer-reviewed studies to doctors that find evidence of usefulness for drugs in off-label uses. Also, they should be able to say that things like "there are studies that indicate propranolol may be effective in treating angina" if such studies exist. If they don't exist, then that is a fraudulent claim. False advertising is already against the law and always will be. Do you oppose the U.S. Constitution too? Do you disagree with the court decision that determined that illegal censorship was occuring? ] 17:43, 30 March 2007 (UTC) | |||
| :::And please don't talk to me about ] until you find one economist that's supportive of keeping FDA's level of restrictiveness or tightening it. Such support simply does not exist. ] 17:49, 30 March 2007 (UTC) | |||
| You seem to be focusing on my personal beliefs, which is again taking this discussion into an area which the ] suggest we avoid. I'd suggest ] on what you perceive to be my "pro-Big-Brother" mentality or dislike for the Constitution. Regarding the only actual article issue you raise: you are claiming that a broad consensus exists among economists that FDA regulation is harmful. According to ], if you're claiming a consensus exists, then you need to provide some sourcing that such a consensus exists. An article in a libertarian journal from a libertarian economist saying he personally doesn't know of anyone who disagrees with him does not prove consensus. ''']''' <sup>]</sup> 18:42, 30 March 2007 (UTC) | |||
| :If someone opposes the FDA, then that makes them a libertarian in your book by definition doesn't it? Which came first, the chicken or the egg, libertarianism or opposition to the FDA? Your criticism is circular. Secondly, the source saying that a consensus exists is indeed published in a "libertarian" journal. But, as I'm sure will be much to your dimay to hear, it was also published in Knowledge, Technology, & Policy journal Volume 13, Number 1/May 1, 2000. pp. 92-101. ISSN 0897-1986 . Thirdly, the economist did not say that "he personally doesn't know of anyone who disagrees with him." He said he researched to find studies that supported the FDA, and there is no indication that he only consulted the writings of people he knows personally. ] 18:51, 30 March 2007 (UTC) | |||
| ::The source you're citing there seems to be a collection of writings from selected economists specifically opposed to the FDA, so I don't see how it's representative of a broad consensus in the field. Perhaps you're right about labeling as "libertarian" being fruitless; nonetheless, I don't think the sources you've cited demonstrate a clear consensus in the economics community. ''']''' <sup>]</sup> 19:01, 30 March 2007 (UTC) | |||
| :::If there no economists can be found, by you, me, or Klein, supporting the present restrictiveness or increased restrictiveness, and if the only economists that can found writing about the FDA favor liberalization, then how can you conclude otherwise than that is the consensus of economists that write about the FDA that they favor liberalization? ] 19:10, 30 March 2007 (UTC) | |||
| ==Reading Material for ]== | |||
| OK, you asked for it. Last year a special report on U.S. drug regulation was issued by the Institute of Medicine, one of the four National Academies, which are independant organizations federally chartered to advise the nation on matters of medicine, science and engineering with respect to public policy. The acadamies' members include the leading academic experts in every major field of the social, physical, and biological sciences. Your pal Gary Becker is a member of the National Acadamy of Sciences (one of 21 members who specialize in economics), as are most American Nobel prize winners in the sciences who remain academically active. You can read more about the national acadamies here,, about the IOM here,, and about the NAS here. | |||
| The IOM report was authored by a committee of 16 experts, all of whose primary academic/professional interest is in health care but were trained and/or hold primary faculty positions in fields including clinical medicine, medical research, economics, biostatistics, law, public policy, public health, and the allied health professions. The committee also included former executives from the pharmaceutical, hospital, and health insurance industries. A draft of the report was also sent to a wide variety of organizations from across the political and professional spectrum (including the Competitive Enterprise Institute) so that they could make critical suggestions to the authors prior to publication of the final report. You can read the 29-page executive summary of the committee's findings and reccomendations here. You can purchase and read the full 348 page report here (Full disclosure - I have not read the full report!) | |||
| Overall, the authors call for an increase in the regulatory powers, funding, and independance of the FDA in order to address ongoing deficiencies in the safety of drugs on the American market. I hope you will take the time to read the full executive summary yourself, but here are some quotes from their reccomendations which I found relevent to our recent discussions. Enjoy. | |||
| "First, there is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry (Harris Interactive, 2005; PricewaterhouseCoopers’ Health Research Institute, 2005). Second, the committee learned that most stakeholders—the agency, the industry, consumer organizations, Congress, professional societies, health care entities—appear to agree on the need for certain improvements in the system. Third, the committee found that the drug safety system is impaired by the following factors: serious resource constraints that weaken the quality and quantity of the science that is brought to bear on drug safety; an organizational culture in CDER that is not optimally functional; and unclear and insufficient regulatory authorities particularly with respect to enforcement. Fourth, the committee found that FDA, contrary to its public health mission, and the pharmaceutical industry, contrary to its responsibility to the users of its products (and its shareholders), do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion." | |||
| "The committee recommends that the Secretary of HHS, working with the Secretaries of Veterans Affairs and Defense, develop a public-private partnership with drug sponsors, public and private insurers, for-profit and not-for-profit health care provider organizations, consumer groups, and large pharmaceutical companies to prioritize, plan, and organize funding for confirmatory drug safety and efficacy studies of public health importance. Congress should capitalize the public share of this partnership." | |||
| == History of the FDA == | |||
| "The committee recommends that CDER develop and continually improve a systematic approach to risk-benefit analysis | |||
| for use throughout the FDA in the preapproval and postapproval settings." | |||
| Can anyone offer a reason or explanation as to why the history presented in this article differs from the history found on the FDA's own website? (http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm) ] (]) 01:28, 14 December 2012 (UTC) | |||
| "The assessment of risks and benefits is an activity that does not end at approval, and risk and benefit cannot be considered in isolation of one another." | |||
| :{{u|Jdevola}} Anyone may copy any or all of that history into this article if it improves the Misplaced Pages article. Misplaced Pages will differ because the FDA's own history of itself is not the only perspective of the history of the FDA. | |||
| {{Tlx|PD-USGov-FDA}} | |||
| :]] 12:52, 28 June 2014 (UTC) | |||
| ==Merger Proposal== | |||
| "Expanded research opportunities should be linked explicitly to FDA’s regulatory mission." | |||
| I propose merging ] with ] to create a more NPOV article. if the article becomes to long from the merge, we can split it other ways besides (Criticism vs non criticism )] (]) 23:09, 12 March 2015 (UTC) | |||
| *'''Oppose''' - the criticism article was split for size reasons after a proper discussion and with a clear consensus. ] (]) 19:18, 15 March 2015 (UTC) | |||
| "FDA lacks the clear, unambiguous authority needed to enforce sponsor compliance with regulatory requirements and instead relies on the prospect of productive negotiations with industry. Although the agency historically has made effective use of its “bully pulpit” to compel sponsor compliance, this process leaves potentially critical regulatory action vulnerable to a subjective and highly variable process of exercising individual or agency influence, and to the vicissitudes of changing politics and attitudes toward | |||
| regulation. That is why FDA’s authorities must be clarified and strengthened to empower the agency to take rapid and decisive actions when necessary and appropriate." | |||
| == history- USDA / Dept. of Health and Human Services == | |||
| "The committee recommends that Congress ensure that the Food and Drug Administration has the ability to require such postmarketing risk assessment and risk management programs as are needed to monitor and ensure safe use of drug products. These | |||
| conditions may be imposed both before and after approval of a new drug, new indication, or new dosage, as well as after identification of new contraindications or patterns of adverse events. The limitations imposed should match the specific safety concerns and benefits presented by the drug product. The risk assessment and risk management program may include: | |||
| a. Distribution conditioned on compliance with agency-initiated changes in drug labels. | |||
| b. Distribution conditioned on specific warnings to be incorporated into all promotional materials (including broadcast direct-to-consumer advertising). | |||
| c. Distribution conditioned on a moratorium on DTC advertising. | |||
| d. Distribution restricted to certain facilities, pharmacists, or physicians with special training or experience. | |||
| e. Distribution conditioned on the performance of specified medical procedures. | |||
| f. Distribution conditioned on the performance of specified additional clinical trials or other studies. | |||
| g. Distribution conditioned on the maintenance of an active adverse event surveillance system." | |||
| This important information, from the FDA website, is missing from the article. | |||
| "The committee recommends that Congress provide oversight and enact any needed legislation to ensure compliance by both the | |||
| ''The FDA was transferred from the USDA to the Federal Security Agency in 1940 and to the Department of Health, Education, and Welfare in 1953, which became the Department of Health and Human Services in 1979.'' | |||
| Food and Drug Administration and drug sponsors with the provisions listed above. FDA needs increased enforcement authority and | |||
| --] (]) 20:16, 8 May 2015 (UTC) | |||
| better enforcement tools directed at drug sponsors, which should include fines, injunctions, and withdrawal of drug approval." | |||
| == Major revision to Organization section (rationale) == | |||
| "The committee recommends that Congress amend the Food, Drug and Cosmetic Act to require that product labels carry a special symbol such as the black triangle used in the UK or an equivalent symbol for new drugs, new combinations of active substances, and | |||
| new systems of delivery of existing drugs. The Food and Drug Administration should restrict direct-to-consumer advertising during the period of time the special symbol is in effect." | |||
| I severely cut back the Organization section and update it based on the FDA's website. My main rationale is that there is little need for the deep org information unless you have some information (cited info) to add to a deep org branch -- which I did for one of the directors of a deep org branch. I also wanted to try out the {{tl|Tree list}} functionality, and I think this does provide some added attractiveness to the presentation. --User:Ceyockey (<small>'']''</small>) 03:50, 19 July 2015 (UTC) | |||
| "The committee recommends that FDA evaluate all new data on new molecular entities no later than 5 years after approval. | |||
| Sponsors will submit a report of accumulated data relevant to drug safety and efficacy, including any additional data published | |||
| in a peer-reviewed journal, and will report on the status of any applicable conditions imposed on the distribution of the drug called for at or after the time of approval." | |||
| == Article Evaluation == | |||
| "To support improvements in drug safety and efficacy activities over a product’s lifecycle, the committee recommends that the | |||
| Administration should request and Congress should approve substantially increased resources in both funds and personnel for the Food and Drug Administration." | |||
| There are a few details that would improve this article in a variety of ways. While reading the article I realized that the content of the articles begins with a description of FDA but it does not address the origination of the FDA. A major improvement that I would add to this article is a history section answering questions like; who began FDA and why specifically was it invented? Was the environment being put at risk? or was it just something citizens thought needed to be put in place? This questions are unanswered questions and questions that have not been addressed in the article. Also in the scope and budget section I would recommend that the section expands on who actually regulates the budget and how was the budget originated. | |||
| Like I said, you asked for it :-) -] 23:35, 30 March 2007 (UTC) | |||
| ] (]) 16:43, 18 September 2015 (UTC) | |||
| :Asked for what? What is the above all about? ] 01:13, 31 March 2007 (UTC) | |||
| == What is the Office of Biotechnology? == | |||
| ::You asked for an economist that thinks FDA regulatory powers need to be expanded. I provided a definitive 2006 reference from a panel created by the leading independant scientific organization in the country, of which the top American economists are members. The report's authors include economists. Have you read it yet? -] 01:34, 31 March 2007 (UTC) | |||
| Our article ] states (but does not source) that Miller has worked for FDA in various capacities, and, in particular, that he between 1989 and 1993 was "the founding director of FDA's Office of Biotechnology". Similar claims can be found in background presentations for articles written by Miller. | |||
| :::I have no interest in reading any of the above. If you have economists that say the FDA should be more restrictive then simply add them to the article. I don't know what your point is of all the above. You don't need my permission to add sources to this article. ] 02:06, 31 March 2007 (UTC) | |||
| Can anyone tell me more about this office? It is not enumerated in the present FDA section lists in our pages. Does it exist, or did it exist (and, if so, until when); or are the claims in the Miller article possibly not quite correct? If the FDA Office of Biotechnology still exists, then, where does it belong organisatorically to-day? Does it have a web-page? ] (]) 04:33, 8 May 2016 (UTC) | |||
| ::::I did add it to the article. And I will be removing your obviously innaccurate claim that most economists think FDA regulations should be reduced. -] 02:17, 31 March 2007 (UTC) | |||
| :::::It's not my claim. It's economist Klein's claim, and the claim can stay. Unless you have some way of proving that it's not true. ] 02:25, 31 March 2007 (UTC) | |||
| ::::I'm not sure you will convince others that you are intersted in contributing to an ] article about the FDA if you are not even willing to ''read'' recent, authoritative reports on the subject you have been continuously trying to write about. Kline's claim simply does not hold up to the reality of mainstream expert opinion such as the GAO report and the IOM report I previously cited. Believe it or not, I ''do'' read your references. -] 02:36, 31 March 2007 (UTC) | |||
| :::::What do you mean by "mainstream experts." If someone opposes the FDA, then by your definition that are not mainstreadm. It's circular. ] 02:47, 31 March 2007 (UTC) | |||
| == External links modified == | |||
| ::::::Not really. I posted the GAO reference because it provides support for many of your arguments - but does so in context with the current debate, and in a well-referenced manner. Read it - you might be pleasantly surprised. But please also read the IOM report. Most people seriously engaged in the process of FDA reform do not think in terms of "more" or "less" regulations per se, just "better" and "more effective" ones. They're not out to score ideological points and would not consider themselves "supporters" or "opponants" of the FDA. Neither do I.-] 03:55, 31 March 2007 (UTC) | |||
| Hello fellow Wikipedians, | |||
| Yes, really, if you expect us to slog through article after article from the ], the ], ], and other such reliable sources, you could at least look through the report from the National Academy of Sciences and the Institute of Medicine. ''']''' <sup>]</sup> 02:42, 31 March 2007 (UTC) | |||
| I have just modified one external link on ]. Please take a moment to review . If you have any questions, or need the bot to ignore the links, or the page altogether, please visit ] for additional information. I made the following changes: | |||
| :I don't need to read it. I trust you. I trust that you will represent their arguments accurately. I'm more concerned that the anti-FDA arguments are represented accurately because it appears plain to me that you two are trying to obscure them. ] 02:45, 31 March 2007 (UTC) | |||
| *Added archive https://web.archive.org/web/20130729152814/http://pm.gc.ca/eng/media.asp?id=4511 to http://pm.gc.ca/eng/media.asp?id=4511 | |||
| When you have finished reviewing my changes, you may follow the instructions on the template below to fix any issues with the URLs. | |||
| ::My hope was that if you took some time to familiarize yourself with the mainstream discussion on FDA reform, you might better understand that inserting such an enormous volume of non-mainstream, tangential, and dated criticism is a violation of ]. This really isn't the appropriate place for an original dissertation on philosophical opposition to the very concept of drug regulation. -] 03:48, 31 March 2007 (UTC) | |||
| :::Milton Friedman's ideas are mainstream. So, are Beckers. The ], of which both of them are a part, is mainstream in economics today. The ] is borderline mainstream. ] 04:08, 31 March 2007 (UTC) | |||
| ::::Note that that doesn't mean the mainstream agrees that the FDA should be abolished. It simply means that Friedman's ideas on this are well known in the mainstream. His ideas on the FDA are probably more famous than any other economists ideas, not only among economists but among the general publica as well. His ideas and arguments this are extremely notable, whether anyone agrees with them or not. ] 04:42, 31 March 2007 (UTC) | |||
| {{sourcecheck|checked=false|needhelp=}} | |||
| Note also that I would like to see not only the Over-regulated section full of criticism. But, I would also like to see the Under-regulations section stuffed full of criticims of the FDA as well. The only makes clear the fact that the FDA creates an unresolvable dilemma. ] 05:31, 31 March 2007 (UTC) | |||
| Cheers.—] <span style="color:green;font-family:Rockwell">(])</span> 07:58, 3 October 2017 (UTC) | |||
| ==Rustovo's edits== | |||
| == using sucralose in children's medication == | |||
| What is with changing the name of one of the criticism sections to this: "Criticism: FDA rejects lifesaving medicines."? That's not the criticism. Of course the FDA rejects livesaving medicines. I don't think anyone would dispute that. That's an expected side effect of regulations. The criticism is that the amount of regulation rejects too many good medicines in order to prevent bad medicines out of the market. It the FDA caused more good than harm, it wouldn't be a problem if some people died as a result of the regulations. The criticism is that more harm is done than good. ] 01:13, 31 March 2007 (UTC) | |||
| Using sucralose or any sugar substitute in medical items like Children Benadryl or Pedialyte or any medically used products could present a danger to some not able to tolerate the sugar substitute. Even in very small amounts. In my case, I become very nauseated with a very tiny amount of any product containing any sugar sub. including stevia. ] (]) 18:05, 3 June 2024 (UTC) | |||
| :Your title was way too vague. The FDA has far more regulatory responsibilities than just approving drugs. The title of the section needs to establish that it is talking about drug regulation, and to differentiate it from the other sections that discuss other aspects of FDA drug regulations. -] 01:30, 31 March 2007 (UTC) | |||
| == Add A Fact: "FDA bans ads for unapproved drugs" == | |||
| And what is the point of this: "Economist Robert Higgs argues that FDA regulations and policies do not allow individuals to obtain drugs fitting their own risk/reward judgements."?? That's not his argument. That's a given. Everybody knows that individuals are not allowed to obtain drugs if they're not approved by the FDA. That's not in dipute. His argument is that when the FDA prohibits the purchase and sale of drugs that that not not approved, that the well-being of consumers ,with well-being is properly understood as consumers' prospective and subjective ], is reduced. ] 01:22, 31 March 2007 (UTC) | |||
| I found a fact that might belong in this article. See the quote below | |||
| :I view much of your writing as unnecessarily long - I actually think it hurts your argument. Make your point concisely and link to the full source for those who are interested. Your previous statement was innacurate - the FDA will approve a drug even if it is only safe and effective for a small but identifiable group. See today's statement about the recall of Zelnorm. -] 01:30, 31 March 2007 (UTC) | |||
| <blockquote> | |||
| ::The argument, that is the argumentation, was not even there. What I meant to say is that you deleted the conclusion. The argumentation is too esoteric for this article. The whole conclusion of the analysis is that prohibiting individuals from obtaining drugs because the FDA has not approved those drugs, reduces consumers' welfare. ] 01:34, 31 March 2007 (UTC) | |||
| Food and Drug Administration rules prohibit advertising of drugs that have not been fully approved by the FDA | |||
| </blockquote> | |||
| The fact comes from the following source: | |||
| : https://www.tampabay.com/news/health/2021/10/25/fda-rules-have-blocked-covid-19-vaccine-makers-from-advertising-on-tv/ | |||
| Here is a wikitext snippet to use as a reference: | |||
| Is it too much to ask that you refrain from continually inserting FDA criticisms from over 25 years ago as if they applied to today's FDA? It's hardly relevant what Friedman though of FDA regulation procedures in 1980, so much has changed since then in every aspect of medicine. Leave in a broad thematic quote if you want ('the following flaw is inherent in the idea of drug regulation' etc.), but don't devote entire paragraphs to outdated criticism. -] 01:44, 31 March 2007 (UTC) | |||
| <nowiki> {{Cite web |title=FDA rules have blocked COVID-19 vaccine makers from advertising on TV |url=https://www.tampabay.com/news/health/2021/10/25/fda-rules-have-blocked-covid-19-vaccine-makers-from-advertising-on-tv/ |website=Tampa Bay Times |access-date=2024-09-27 |language=en |quote=Food and Drug Administration rules prohibit advertising of drugs that have not been fully approved by the FDA}} </nowiki> | |||
| :What Friedman said 25 years ago is totally relevant. It's not a study. It's economic REASONING. It applies today and always. His argument is that by the FDA's nature, it can never do more good than harm. It can't be reformed. His writings from back then are still cited today very often, and will continue to be for hundreds of years. There is no reason why they shouldn't be cited here either. ] 01:48, 31 March 2007 (UTC) | |||
| Additional comments from user: For this reason, manufacturers were prohibited from advertising COVID-19 vaccines that had only been approved under Emergency Use Authorization. | |||
| This post was generated using the ] browser extension. | |||
| ::That's not an economic arguement, its a philosophical belief. A economic argument has methodology and data to back it up, and generally applies to a concrete situation. This is not a page on "drug regulation" in general - it is about the specific FDA organization. | |||
| ] ] 04:17, 27 September 2024 (UTC) | |||
| ::I don't think Friedman ever set out to formally show that drug regulation "could never do more good than harm" in an academic paper. Peer reviewers would have laughed him out of the room. If I am mistaken, please provide the reference. What exactly do you have against academic papers from this century? - you haven't provided many to back up your statements. -] 01:55, 31 March 2007 (UTC) | |||
| : '''Note''': I have added this to the article. ] ] 04:22, 27 September 2024 (UTC) | |||
| :::There is no requirement that the criticism in this article have to be from studies, surveys, and statistics. Reasoned arguments from professional economists are allowed, especially when its from the most influential economist of the second half of the 20th century, if not the whole 20th century. You're absolutely wrong that "A economic argument has methodology and data to back it up." Never read Adam Smith's Wealth of Nations? Talk about an influential economist. His methodology was mainly logical argumentation. The greats don't even need to decend to the level of dealing with statistics, etc. ] 02:03, 31 March 2007 (UTC) | |||
Latest revision as of 14:36, 27 September 2024
| Skip to table of contents |
| This is the talk page for discussing improvements to the Food and Drug Administration article. This is not a forum for general discussion of the article's subject. |
|
| Find medical sources: Source guidelines · PubMed · Cochrane · DOAJ · Gale · OpenMD · ScienceDirect · Springer · Trip · Wiley · TWL |
Archives: 1, 2Auto-archiving period: 3 months  |
 | This page is not a forum for general discussion about Food and Drug Administration. Any such comments may be removed or refactored. Please limit discussion to improvement of this article. You may wish to ask factual questions about Food and Drug Administration at the Reference desk. |
 | This  level-5 vital article is rated C-class on Misplaced Pages's content assessment scale.It is of interest to the following WikiProjects: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
.svg)
 Archives |
|
This page has archives. Sections older than 90 days may be automatically archived by Lowercase sigmabot III when more than 10 sections are present. |
Move article to US Food and Drug Administration
I think a better title should be considered for the article, "Food and Drug Administration" sounds odd and US-centric. Notice that it was suggested before (see above) that the article should be moved to "United States Food and Drug Administration". I would vote for the more simple "US Food and Drug Administration". 90.184.5.10 (talk) 00:00, 4 October 2012 (UTC)
- "Food and Drug Administration" is the actual name of the organization. There is no other organization with this name in any other country. Per WP:TITLE Misplaced Pages uses the actual name of things for the article title unless there is a reason to differentiate multiple items with the same name. Blue Rasberry (talk) 12:56, 28 June 2014 (UTC)
- A good point is that "FDA" to a very large extent has become synonymous with the US Food and Drug Administration. Even so, it turns out that there are other FDAs around, for instance the Thai FDA and the Saudi Food & Drug Authority. Also, concerning the actual name used by the US FDA, the headline of the website says: "U.S. Food and Drug Administration". If you live in the US, UK, Canada, Australia, etc., I am sure that the term "Food and Drug Administration" is understood simply as a shortening of "U.S. Food and Drug Administration" but I would think that other English speakers/readers find it odd that "Food and Drug Administration" links directly to the U.S. Food and Drug Administration article instead of, for instance, a disambiguation page. --90.185.131.137 (talk) 15:30, 26 July 2014 (UTC)
History of the FDA
Can anyone offer a reason or explanation as to why the history presented in this article differs from the history found on the FDA's own website? (http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm) Jdevola (talk) 01:28, 14 December 2012 (UTC)
- Jdevola Anyone may copy any or all of that history into this article if it improves the Misplaced Pages article. Misplaced Pages will differ because the FDA's own history of itself is not the only perspective of the history of the FDA.
{{PD-USGov-FDA}}
Merger Proposal
I propose merging Criticism of the Food and Drug Administration with Food and Drug Administration to create a more NPOV article. if the article becomes to long from the merge, we can split it other ways besides (Criticism vs non criticism )Bryce Carmony (talk) 23:09, 12 March 2015 (UTC)
- Oppose - the criticism article was split for size reasons after a proper discussion and with a clear consensus. andy (talk) 19:18, 15 March 2015 (UTC)
history- USDA / Dept. of Health and Human Services
This important information, from the FDA website, is missing from the article. The FDA was transferred from the USDA to the Federal Security Agency in 1940 and to the Department of Health, Education, and Welfare in 1953, which became the Department of Health and Human Services in 1979. --Naytz (talk) 20:16, 8 May 2015 (UTC)
Major revision to Organization section (rationale)
I severely cut back the Organization section and update it based on the FDA's website. My main rationale is that there is little need for the deep org information unless you have some information (cited info) to add to a deep org branch -- which I did for one of the directors of a deep org branch. I also wanted to try out the {{Tree list}} functionality, and I think this does provide some added attractiveness to the presentation. --User:Ceyockey (talk to me) 03:50, 19 July 2015 (UTC)
Article Evaluation
There are a few details that would improve this article in a variety of ways. While reading the article I realized that the content of the articles begins with a description of FDA but it does not address the origination of the FDA. A major improvement that I would add to this article is a history section answering questions like; who began FDA and why specifically was it invented? Was the environment being put at risk? or was it just something citizens thought needed to be put in place? This questions are unanswered questions and questions that have not been addressed in the article. Also in the scope and budget section I would recommend that the section expands on who actually regulates the budget and how was the budget originated.
TrishaTidwell (talk) 16:43, 18 September 2015 (UTC)
What is the Office of Biotechnology?
Our article Henry I. Miller states (but does not source) that Miller has worked for FDA in various capacities, and, in particular, that he between 1989 and 1993 was "the founding director of FDA's Office of Biotechnology". Similar claims can be found in background presentations for articles written by Miller.
Can anyone tell me more about this office? It is not enumerated in the present FDA section lists in our pages. Does it exist, or did it exist (and, if so, until when); or are the claims in the Miller article possibly not quite correct? If the FDA Office of Biotechnology still exists, then, where does it belong organisatorically to-day? Does it have a web-page? JoergenB (talk) 04:33, 8 May 2016 (UTC)
External links modified
Hello fellow Wikipedians,
I have just modified one external link on Food and Drug Administration. Please take a moment to review my edit. If you have any questions, or need the bot to ignore the links, or the page altogether, please visit this simple FaQ for additional information. I made the following changes:
- Added archive https://web.archive.org/web/20130729152814/http://pm.gc.ca/eng/media.asp?id=4511 to http://pm.gc.ca/eng/media.asp?id=4511
When you have finished reviewing my changes, you may follow the instructions on the template below to fix any issues with the URLs.
This message was posted before February 2018. After February 2018, "External links modified" talk page sections are no longer generated or monitored by InternetArchiveBot. No special action is required regarding these talk page notices, other than regular verification using the archive tool instructions below. Editors have permission to delete these "External links modified" talk page sections if they want to de-clutter talk pages, but see the RfC before doing mass systematic removals. This message is updated dynamically through the template {{source check}} (last update: 5 June 2024).
- If you have discovered URLs which were erroneously considered dead by the bot, you can report them with this tool.
- If you found an error with any archives or the URLs themselves, you can fix them with this tool.
Cheers.—InternetArchiveBot (Report bug) 07:58, 3 October 2017 (UTC)
using sucralose in children's medication
Using sucralose or any sugar substitute in medical items like Children Benadryl or Pedialyte or any medically used products could present a danger to some not able to tolerate the sugar substitute. Even in very small amounts. In my case, I become very nauseated with a very tiny amount of any product containing any sugar sub. including stevia. 2603:8081:6103:6E00:9DA0:5E23:DB1F:C9D9 (talk) 18:05, 3 June 2024 (UTC)
Add A Fact: "FDA bans ads for unapproved drugs"
I found a fact that might belong in this article. See the quote below
Food and Drug Administration rules prohibit advertising of drugs that have not been fully approved by the FDA
The fact comes from the following source:
Here is a wikitext snippet to use as a reference:
{{Cite web |title=FDA rules have blocked COVID-19 vaccine makers from advertising on TV |url=https://www.tampabay.com/news/health/2021/10/25/fda-rules-have-blocked-covid-19-vaccine-makers-from-advertising-on-tv/ |website=Tampa Bay Times |access-date=2024-09-27 |language=en |quote=Food and Drug Administration rules prohibit advertising of drugs that have not been fully approved by the FDA}}
Additional comments from user: For this reason, manufacturers were prohibited from advertising COVID-19 vaccines that had only been approved under Emergency Use Authorization.
This post was generated using the Add A Fact browser extension.
BD2412 T 04:17, 27 September 2024 (UTC)
- Note: I have added this to the article. BD2412 T 04:22, 27 September 2024 (UTC)
- C-Class level-5 vital articles
- Misplaced Pages level-5 vital articles in Society and social sciences
- C-Class vital articles in Society and social sciences
- C-Class Food and drink articles
- High-importance Food and drink articles
- WikiProject Food and drink articles
- C-Class pharmacology articles
- High-importance pharmacology articles
- WikiProject Pharmacology articles
- C-Class medicine articles
- Low-importance medicine articles
- C-Class society and medicine articles
- Top-importance society and medicine articles
- Society and medicine task force articles
- C-Class toxicology articles
- High-importance toxicology articles
- Toxicology task force articles
- All WikiProject Medicine pages
- C-Class Alternative medicine articles
- C-Class organization articles
- Low-importance organization articles
- WikiProject Organizations articles
- C-Class Maryland articles
- Mid-importance Maryland articles
- WikiProject Maryland articles
- C-Class Science Policy articles
- High-importance Science Policy articles
- C-Class United States articles
- Low-importance United States articles
- C-Class United States articles of Low-importance
- C-Class United States Government articles
- Low-importance United States Government articles
- WikiProject United States Government articles
- WikiProject United States articles
- C-Class politics articles
- Low-importance politics articles
- C-Class American politics articles
- Low-importance American politics articles
- American politics task force articles
- WikiProject Politics articles