WASHINGTON (May 30, 2024) — The Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, today submitted comments to the U.S. Department of Health and Human Services and the Federal Trade Commission in response to a request for Information to better understand how the practices of pharmaceutical middlemen—group purchasing organizations and drug wholesalers—may be contributing to generic drug shortages.
“The sustainability of competitive generic and biosimilar markets and the continuing supply of Food and Drug Administration approved/licensed generic and biosimilar medicines for patients, uninterrupted by shortages, is in jeopardy,” said David Gaugh, Interim President and CEO of AAM. “Although generic and biosimilar manufacturers have contributed to dramatically lower rates of health care spending, their ability to continue to provide affordable medicines is threatened by excessive consolidation of intermediary participants – group purchasing organizations (at both the retail and hospital levels), wholesalers, and pharmacy benefit managers.
The letter requests that the FTC issue a section 6(b) Order to investigate the contracting practices of buying groups that contribute to the root causes of drug shortages. AAM also suggests that the agencies issue new Statements of Antitrust Enforcement Policy in Healthcare that lower the (now withdrawn) “market power” safe harbors for buying groups; and revise and/or clarify the Anti-Kickback Statute safe harbor provisions to exclude anticompetitive fees and charges imposed by Buying Groups.
Gaugh continued, “As AAM notes in its full written statement, without remedial action, the high concentration of buying power in the generic and biosimilar markets – combined with anti-competitive contract terms – will continue to cause harm to patients and consumers in the form of terminated or abandoned products and drug shortages. This, combined with poorly designed federal and state policies, has driven generics and biosimilars to unsustainably low prices. The agencies should act to reverse this trend by striking the right balance between affordability to the health care system and incentives to reinvigorate robust generic and biosimilar markets.”
For media inquiries, contact the Communications department at media@accessiblemeds.org.
About AAM
The Association for Accessible Medicines, your generics and biosimilars industry, is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers of finished generic pharmaceuticals and biosimilars, manufacturers of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 17.5 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.
