WASHINGTON (April 1, 2025) — The Association for Accessible Medicines today commented on staffing cuts at the Food and Drug Administration, including key personnel responsible for programs funded by user fees from generic and biosimilar manufacturers.
“AAM is deeply concerned by reports that key officials within the FDA’s generic drug and biosimilar programs and officials responsible for administering the industry user fee programs were let go from the Agency,” said John Murphy III, President and CEO of AAM. “While we support improving FDA efficiency to deliver more affordable generic and biosimilar medicines to patients faster, many of the reported cuts appear to do the opposite.”
A strong and efficient FDA is essential to ensuring the availability of safe and effective affordable medicines for America’s patients—medicines that have saved the U.S. healthcare system over $3 trillion in the past 10 years. Today’s staff reductions may undermine the Agency’s ability to approve and ensure the safety of lower-cost generic and biosimilar medicines.
The sustainability of the generic industry in the U.S. is already threatened due to increasingly consolidated purchaser markets, unsustainably low reimbursement levels, and continued threats to new launches from patent games by brand drug manufacturers. A decrease in the expertise and capacity within the FDA to review and approve generic and biosimilar medicines will severely and broadly impact patient care.
Murphy continued, “On behalf of our members and the health of America’s patients, we look forward to engaging with the newly confirmed Commissioner Makary to address our concerns and to continue advancing reforms that strengthen the FDA’s efficiency, resiliency, and commitment to quality.”
View AAM 2025 Advocacy Priorities
For media inquiries, contact 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. 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 13.1 percent of total drug spending.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines, works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is the 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, government affairs, legal affairs, and regulatory policy. More information is available at biosimilarscouncil.org.
