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Association for Accessible Medicines

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The Generic Pharmaceutical Association (GPhA), Washington, D.C., is a trade association representing the manufacturers and distributors of generic prescription drugs, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the U.S. generic drug industry. As the primary lobby for makers of generic drugs,[1] GPhA’s stated mission is to advocate for public policies that facilitate timely access to lower-cost, FDA-approved generic medicines by consumers and patients. Over the 10-year period 2003 thru 2012, the use of generic drugs generated $1.2 trillion in U.S. healthcare savings.[2]

History

GPhA was formed in May 2000 by the merger of the Generic Pharmaceutical Industry Association (GPIA) and the National Pharmaceutical Alliance (NPA). In January 2001, the other generic industry trade association in operation at the time, the National Association of Pharmaceutical Manufacturers (NAPM), merged with the newly formed GPhA, which completed the consolidation of three U.S.-focused generic trade associations into one national advocacy organization.[3]

In 2003, GPhA supported passage of the Medicare Prescription Drug, Improvement, and Modernization Act (also called the Medicare Modernization Act or MMA), which resulted in the largest overhaul of Medicare in the public health program's history and created prescription drug coverage for Medicare beneficiaries (Medicare Part D).[4]

In 2004, GPhA began promoting the potential benefits of developing a market for biosimilar versions of biologic therapies and provided answers to questions that the FDA posed in a September 2004 workshop on the scientific challenges of creating biosimilars.[5] On May 2, 2007, GPhA's then-Chairman Bruce Downey testified before the House Energy and Commerce Committee Subcommittee on Health, urging Congress to pass legislation giving FDA the authority to approve biosimilars.[6] Congress created an approval pathway for biosimilars (including interchangeables that are substitutable with their reference product) with passage of the Biologics Price Competition and Innovation Act, part of the Patient Protection and Affordable Care Act signed by President Obama on March 23, 2010. In 2015, GPhA launched the Biosimilars Council, which works to ensure a positive regulatory, reimbursement, political and policy environment for biosimilar products, and provide information to the public about the safety and effectiveness of biosimilars.[7] [8]

In 2011 and 2012, GPhA and the U.S. Food and Drug Administration negotiated the Generic Drug User Fee Act (GDUFA), which requires manufacturers of generic prescription drugs to pay application fees when submitting Abbreviated New Drug Applications (ANDAs) seeking approval for generic products.[9]

GPhA is the U.S. representative to the International Generic and Biosimilar Medicines Association (IGBA),[10] which advocates global interests of the generic pharmaceutical industry in collaborates with the Canadian Generic Pharmaceutical Association,[11] Medicines for Europe, Japan Generic Medicines Association,[12] and other IGBA members.

Leadership

Chester “Chip” Davis, Jr. is the President and Chief Executive Officer of GPhA. Appointed to the position by the GPhA Board of Directors in summer 2015,[13] Prior to joining GPhA, Davis served as Executive Vice President for Advocacy and Member Relations at the Pharmaceutical Research and Manufacturers of America (PhRMA). Prior to joining PhRMA, he was Vice President of Corporate External Relations for AstraZeneca. He holds an undergraduate degree in Accounting from the University of Delaware, and a Juris Doctor from the University of Baltimore School of Law. Heather Bresch serves as Chair of the GPhA Board of Directors. Bresch is Chief Executive Officer of Mylan N.V.

Programs

  • In furtherance of its mission, GPhA supports and promotes the following core objectives: sustainability, growth and competitiveness of the U.S. generic and biosimilars medicines industry; initiatives that promote the substitution of medicines deemed interchangeable; advancement of one quality standard for medicines for generic and brand drugs distributed in the U.S.; and legislation, such as the Senate's 2016 CREATES Act, that removes barriers and advance more timely patient access to generic and biosimilar medicines.[14]

Membership

GPhA members include more than 30 pharmaceutical manufacturers and an additional 60 other companies that manufacturer and distributor bulk pharmaceutical chemicals, supply contract research services, or provide other goods and services to the generic drug industry. Generic manufacturers supply more than 80 percent of the prescription medicine sold in the U.S.[15]

References

  1. ^ Pear, Robert. “Top Pharmaceutical Lobbyist Threads A Thicket of Outrage“, The New York Times, 26 February 2016. Retrieved on 15 July 2016.
  2. ^ Rosenthal, Elisabeth. “Officials Question the Rising Costs of Generic Drugs”, The New York Times, 7 October 2014. Retrieved on 11 July 2016.
  3. ^ “GPhA and NAPM merge as 'one voice'”, Medical Marketing & Media, Vol. 36 Issue 3, p. 34, New York, March 2001. Retrieved on 7 July 2016.
  4. ^ “Consumers Poised for Landmark Win as Congress Passes Medicare Bill with Affordable Pharmaceuticals Measure”, PRNewswire, Washington, 27 June 2003. Retrieved on 29 June 2016.
  5. ^ “GPhA Answers FDA Workshop Questions on Biogenerics”, FDA News, Washington, 11 January 2005. Retrieved on 10 July 2016.
  6. ^ https://www.gpo.gov/fdsys/pkg/CHRG-110hhrg40500/html/CHRG-110hhrg40500.htm
  7. ^ http://biosimilarscouncil.org
  8. ^ “GPhA Launches Biosimilars Council, New Industry Group Will Educate and Advocate for Patient Access to Safe, Affordable Lifesaving Medicines”, PRNewswire, Washington, 16 April 2015. Retrieved on 29 June 2016.
  9. ^ “GPhA Requests Prompt Action on User Fee Proposal”, Biosimilar News, 6 April 2012. Retrieved on 29 May 28, 2016.
  10. ^ http://www.igbamedicines.org/
  11. ^ http://www.canadiangenerics.ca/
  12. ^ http://www.jga.gr.jp/english/
  13. ^ Thulin, Lesley. “Chip Davis named GPhA president, CEO”, Drug Store News, New York, 22 July 2015. Retrieved on 10 June 2016.
  14. ^ Bartz, Diane. “Senators introduce bill aimed at getting generic drugs to market”, Reuters, New York, 14 June 2016. Retrieved on 10 July 2016.
  15. ^ Levick, Richard. “Generic Drug Makers Will Soon Face the Regulatory Music”, ‘’Forbes’’, 15 July 2013. Retrieved on 7 July 2016.
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