The Association for Accessible Medicines (AAM), 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] AAM's stated mission is to advocate for public policies that facilitate timely access to lower-cost, FDA-approved generic and biosimilar medicines by consumers and patients. Over the 10-year period 2008 through 2018, the use of generic drugs generated $2 trillion in U.S. healthcare savings.[2]

Prior to February 2017, AAM was the Generic Pharmaceutical Association (GPhA).[3]

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.[4]

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).[5]

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.[6] 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.[7] 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.[8] [9]

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.[10]

GPhA is the U.S. representative to the International Generic and Biosimilar Medicines Association (IGBA),[11] which advocates global interests of the generic pharmaceutical industry in collaborates with the Canadian Generic Pharmaceutical Association,[12] Medicines for Europe, Japan Generic Medicines Association,[13] and other IGBA members.

Leadership

Dan Leonard is the Chief Executive Officer of AAM. He succeeds Chester "Chip" Davis, Jr. who is now the President and Chief Executive Officer of the Healthcare Distribution Alliance. Alok Sonig, CEO, US Generics and Global Head, Generics R&D & Biosimilars of Lupin Pharmaceuticals serves as Chair of the GPhA Board of Directors. [14]

Programs

  • In furtherance of its mission, AAM supports and promotes more timely patient access to generic and biosimilar medicines.

Membership

AAM members include almost 30 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 90 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. ↑ IQVIA. “2019 Generic Drug and Biosimilars Access & Savings in the U.S. Report”
  3. ↑ "Introducing the New Association for Accessible Medicines (AAM)". Association for Accessible Medicines. Retrieved 1 May 2017.
  4. ↑ “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.
  5. ↑ “Consumers Poised for Landmark Win as Congress Passes Medicare Bill with Affordable Pharmaceuticals Measure”, PRNewswire, Washington, 27 June 2003. Retrieved on 29 June 2016.
  6. ↑ “GPhA Answers FDA Workshop Questions on Biogenerics”, FDA News, Washington, 11 January 2005. Retrieved on 10 July 2016.
  7. ↑ "- ASSESSING THE IMPACT OF A SAFE AND EQUITABLE BIOSIMILAR POLICY IN THE UNITED STATES". www.govinfo.gov.
  8. ↑ "Home - Biosimilars Council - Leading Resource on Biosimilars". Biosimilars Council.
  9. ↑ “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.
  10. ↑ “GPhA Requests Prompt Action on User Fee Proposal”, Biosimilar News, 6 April 2012. Retrieved on 29 May 28, 2016.
  11. ↑ "International Generic and Biosimilar Medicines Association - IGBA". www.igbamedicines.org.
  12. ↑ "CGPA – Canadian Generic Pharmaceutical Association".
  13. ↑ "日本ジェネリック製薬協会 ｜HOME". www.jga.gr.jp.
  14. ↑ "AAM Statement on the Resignation of Chip Davis", AAM Press Releases, 10 February, 2020.
  15. ↑ “FDA: Generic Drugs ”, FDA, 2 May 2021. Retrieved on 14 May 2021.
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