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Bresch persuaded several of Mylan's competitors to support what became the Generic Drug User Fee Act, which she proposed to lawmakers in 2010. Under the law the pharmaceutical industry would pay fees of $300 million in order to fund FDA inspections of foreign drug manufacturing facilities at the same rate as US-based facilities.<ref name="seven"/><ref name="two"/><Ref name="three"/><ref>{{cite news|newspaper=Ernst & Young|title=Esquire's Americans of the year:Patriots|url=http://www.esquire.com/features/americans-2011/patriots-of-the-year-2011-1211-4#slide-4|newspaper=Esquire|accessdate=September 26, 2014|first=Tim|last=Heffernan}}</ref> Bresch made regular visits to Washington, D.C.<Ref name="barrons">{{cite news|title=Medicine Woman|newspaper=Barron's|first=Leslie|last=Norton|date=March 2, 2013|url=http://online.barrons.com/news/articles/SB50001424052748704356104578326350757421498|accessdate=September 26, 2014}}</ref> and lobbied aggressively for the law,<Ref name="three">{{cite news|title=Deal in Place for Inspecting Foreign Drugs|first=Gardiner|last=Harris|date=August 13, 2011|url=http://www.nytimes.com/2011/08/13/science/13drug.html?pagewanted=all|accessdate=September 26, 2014|newspaper=The New York Times}}</reF> arguing that a lack of regulation put U.S. manufacturers at a disadvantage over unregulated manufacturers abroad.<ref name="two"/> The Generic Drug User Fee Act of 2012 was passed on July 9, 2012 and required FDA inspections of pharmaceutical manufacturing locations abroad if they are importing into the U.S.<ref name="barrons"/> Bresch persuaded several of Mylan's competitors to support what became the Generic Drug User Fee Act, which she proposed to lawmakers in 2010. Under the law the pharmaceutical industry would pay fees of $300 million in order to fund FDA inspections of foreign drug manufacturing facilities at the same rate as US-based facilities.<ref name="seven"/><ref name="two"/><Ref name="three"/><ref>{{cite news|newspaper=Ernst & Young|title=Esquire's Americans of the year:Patriots|url=http://www.esquire.com/features/americans-2011/patriots-of-the-year-2011-1211-4#slide-4|newspaper=Esquire|accessdate=September 26, 2014|first=Tim|last=Heffernan}}</ref> Bresch made regular visits to Washington, D.C.<Ref name="barrons">{{cite news|title=Medicine Woman|newspaper=Barron's|first=Leslie|last=Norton|date=March 2, 2013|url=http://online.barrons.com/news/articles/SB50001424052748704356104578326350757421498|accessdate=September 26, 2014}}</ref> and lobbied aggressively for the law,<Ref name="three">{{cite news|title=Deal in Place for Inspecting Foreign Drugs|first=Gardiner|last=Harris|date=August 13, 2011|url=http://www.nytimes.com/2011/08/13/science/13drug.html?pagewanted=all|accessdate=September 26, 2014|newspaper=The New York Times}}</reF> arguing that a lack of regulation put U.S. manufacturers at a disadvantage over unregulated manufacturers abroad.<ref name="two"/> The Generic Drug User Fee Act of 2012 was passed on July 9, 2012 and required FDA inspections of pharmaceutical manufacturing locations abroad if they are importing into the U.S.<ref name="barrons"/>


Bresch has also advocated for broader availability of EpiPens in public places to treat anaphylaxis (severe allergic reactions),<ref name="barrons"/> and has been active in raising awareness of HIV/AIDS treatment in developing nations.<Ref name="six">{{cite news|author=Ernst & Young|title=Entrepreneur of the Year 2014|date=June 22, 2014|publisher=Trib Total Media}}</ref><Ref>{{cite news|title=Mylan to continue fast pace of growth under Bresch|date=May 31, 2012|url=http://www.statejournal.com/story/18666205/mylan-to-continue-fast-pace-of-growth-under-bresch|newspaper=The State Journal|accessdate=September 27, 2014}}</ref> She helped facilitate the School Access to Emergency Epinephrine Act, which made epinephrine more accessible in schools.<ref name="uhioq">{{cite news|newspaper=Fortune Magazine|url=http://fortune.com/2013/11/21/mylan-ceo-heather-bresch-on-why-she-admires-bill-gates/|title=Mylan CEO Heather Bresch on why she admires Bill Gates|accessdate=October 4, 2014|date=November 21, 2013|first=Colleen|last=Leahey}}</reF> Forty one U.S. states now have policies or laws recommending that schools keep epinephrine auto-injectors in stock.<ref>{{cite news|title=EpiPens in Schools Save Lives, Study Says|publisher=WebMD|first=Robert|last=Preidt|accessdate=December 5, 2014|date=November 7, 2014|url=http://www.webmd.com/allergies/news/20141107/schools-with-epipens-save-lives-study-says }}</ref><ref>{{cite news|url=http://www.sacbee.com/news/local/health-and-medicine/healthy-choices/article3873646.html|title=New law requires California schools to stock epinephrine injectors for allergic children|newspaper=The Sacramento Bee|accessdate=December 5, 2014|date=November 12, 2014|first=Sammy|last=Caiola}}</ref> Bresch has also advocated for broader availability of EpiPens in public places to treat anaphylaxis (severe allergic reactions),<ref name="barrons"/> and has been active in raising awareness of HIV/AIDS treatment in developing nations.<Ref name="six">{{cite news|author=Ernst & Young|title=Entrepreneur of the Year 2014|date=June 22, 2014|publisher=Trib Total Media}}</ref><Ref>{{cite news|title=Mylan to continue fast pace of growth under Bresch|date=May 31, 2012|url=http://www.statejournal.com/story/18666205/mylan-to-continue-fast-pace-of-growth-under-bresch|newspaper=The State Journal|accessdate=September 27, 2014}}</ref> She helped facilitate the School Access to Emergency Epinephrine Act, which made epinephrine more accessible in schools.<ref name="uhioq">{{cite news|newspaper=Fortune Magazine|url=http://fortune.com/2013/11/21/mylan-ceo-heather-bresch-on-why-she-admires-bill-gates/|title=Mylan CEO Heather Bresch on why she admires Bill Gates|accessdate=October 4, 2014|date=November 21, 2013|first=Colleen|last=Leahey}}</reF>


==References== ==References==

Revision as of 07:40, 17 February 2015

Government relations and advocacy

From 2002 to 2005, Bresch served as Mylan's director of government relations. She contributed to the development of the 2003 Medicare Prescription Drug, Improvement, and Modernization Act (MMA), which provided medical coverage for prescription drugs to seniors through medicare.

When Mylan expanded internationally, Bresch noticed that Mylan's US-based pharmaceutical manufacturing plant had full-time staff from the Food and Drug Administration (FDA) devoted to it, whereas facilities abroad had not been inspected by the FDA for more than a decade. This was because the 1938 Federal Food, Drug and Cosmetic Act was written before the advent of mass manufacturing of U.S. prescription drugs in other countries and didn't give the FDA authority or resources to inspect foreign pharmaceutical manufacturing facilities.

Bresch persuaded several of Mylan's competitors to support what became the Generic Drug User Fee Act, which she proposed to lawmakers in 2010. Under the law the pharmaceutical industry would pay fees of $300 million in order to fund FDA inspections of foreign drug manufacturing facilities at the same rate as US-based facilities. Bresch made regular visits to Washington, D.C. and lobbied aggressively for the law, arguing that a lack of regulation put U.S. manufacturers at a disadvantage over unregulated manufacturers abroad. The Generic Drug User Fee Act of 2012 was passed on July 9, 2012 and required FDA inspections of pharmaceutical manufacturing locations abroad if they are importing into the U.S.

Bresch has also advocated for broader availability of EpiPens in public places to treat anaphylaxis (severe allergic reactions), and has been active in raising awareness of HIV/AIDS treatment in developing nations. She helped facilitate the School Access to Emergency Epinephrine Act, which made epinephrine more accessible in schools.

References

  1. ^ Burnside, Mary. "Leading Ladies". Corridor Magazine. pp. 16–20.
  2. Bosco, Andrea (April 22, 2014). "Mylan CEO Continues To Expand International Medicine Efforts". WHIRL Magazine. Retrieved September 26, 2014.
  3. Bowman, Nikki (June 11, 2012). "No Generic Success Story". West Virginia Living. Retrieved September 26, 2014.
  4. "Bush signs landmark Medicare bill into law". CNN. December 8, 2003. Retrieved September 26, 2014.
  5. ^ Harris, Gardiner (August 13, 2011). "Deal in Place for Inspecting Foreign Drugs". The New York Times. Retrieved September 26, 2014.
  6. ^ Clemons, Steve (June 12, 2012). "What it really takes to change Washington". The Atlantic. Retrieved September 16, 2014.
  7. Heffernan, Tim. "Esquire's Americans of the year:Patriots". Esquire. Retrieved September 26, 2014.
  8. ^ Norton, Leslie (March 2, 2013). "Medicine Woman". Barron's. Retrieved September 26, 2014.
  9. Ernst & Young (June 22, 2014). "Entrepreneur of the Year 2014". Trib Total Media.
  10. "Mylan to continue fast pace of growth under Bresch". The State Journal. May 31, 2012. Retrieved September 27, 2014.
  11. Leahey, Colleen (November 21, 2013). "Mylan CEO Heather Bresch on why she admires Bill Gates". Fortune Magazine. Retrieved October 4, 2014.
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