Calls for support, continuity, and consistency at the agency

WASHINGTON (December 8, 2025) — The Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, today commented on the U.S. Food and Drug Administration and the retirement of Dr. Richard Pazdur, who joined the FDA in 1999, as director of the Oncology Center of Excellence:

Dr. Richard Pazdur has dedicated his career to advancing public health, strengthening scientific rigor, and ensuring that patients across the country benefit from safe and effective therapies. His decades of service helped solidify the FDA’s reputation as the world’s leading regulatory authority, and his contributions to oncology and regulatory innovation will leave a lasting legacy.

As the agency navigates this transition, AAM remains confident in the FDA’s deep bench of scientific and regulatory expertise. The strength of the FDA has always come from its people; dedicated public servants that uphold the highest standards of safety, quality, and integrity. We are grateful for their continued commitment and for the stability they provide to patients and to America’s healthcare system.

It is important to support the FDA in maintaining continuity and consistency in its operations. Ensuring steady leadership helps the FDA continue carrying out its mission effectively and provides the predictability that patients, healthcare providers, and the broader pharmaceutical ecosystem rely on every day.

The generic and biosimilar medicines industry relies on a strong, well-resourced, and science-driven FDA to expand patient access, support a competitive marketplace, and ensure the medicines Americans depend on every day are safe, effective, and affordable. We look forward to continuing our collaboration with the FDA. AAM stands ready to support the agency during this period of transition. We are confident that the FDA will continue to embody the regulatory excellence that has long made it the global standard.

AAM 2025 Advocacy Priorities

2025 U.S. Generic & Biosimilar Medicines Savings Report

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 12 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 biosimilarscouncil.org.