The Association for Accessible Medicines (AAM), Washington, D.C., is a

trade association A trade association, also known as an industry trade group, business association, sector association or industry body, is an organization founded and funded by businesses that operate in a specific Industry (economics), industry. Through collabor ...

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, AAM's stated mission is to advocate for

public policies Public policy is an institutionalized proposal or a decided set of elements like laws, regulations, guidelines, and actions to solve or address relevant and problematic social issues, guided by a conception and often implemented by programs. T ...

that facilitate timely access to lower-cost,

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

-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. Prior to February 2017, AAM was the Generic Pharmaceutical Association (GPhA).

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. In 2003, GPhA supported passage of the

Medicare Prescription Drug, Improvement, and Modernization Act The Medicare Prescription Drug, Improvement, and Modernization Act, also called the Medicare Modernization Act or MMA, is a federal law of the United States, enacted in 2003. It produced the largest overhaul of Medicare in the public health pro ...

(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 Medicare (United States), Medicare Part D, also called the Medicare prescription drug benefit, is an optional United States federal-government program to help Medicare beneficiaries pay for self-administered prescription drugs. Part D was enact ...

). In 2004, GPhA began promoting the potential benefits of developing a market for

biosimilar A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved ...

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. 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. 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 A patient is any recipient of health care services that are performed by healthcare professionals. The patient is most often ill or injured and in need of treatment by a physician, nurse, optometrist, dentist, veterinarian, or other health ...

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. In 2011 and 2012, GPhA and the

U.S. Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

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

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.“FDA: Generic Drugs ”
, ''

'', 2 May 2021. Retrieved on 14 May 2021.

References

Generic Drug Savings in the United States 7th edition.

External links

* {{official website, https://accessiblemeds.org/ Lobbying organizations in the United States 2000 establishments in Washington, D.C. Pharmaceutical industry trade groups Health industry trade groups based in the United States