AAM urges reauthorization of FDA user fee programs

WASHINGTON — The Association for Accessible Medicines and its Biosimilars Council are urging timely congressional reauthorization of FDA user-fee programs for generic and biosimilar medicines, saying the agreements are critical to improving regulatory efficiency and expanding patient access to lower-cost treatments.

The groups issued their statement following the GDUFA IV public meeting and ahead of the upcoming BsUFA IV public meeting, as negotiations continue on the next iterations of the Generic Drug User Fee Amendments and Biosimilar User Fee Amendments.

“With the GDUFA IV public meeting now behind us and as stakeholders prepare for the upcoming BsUFA IV public meeting, we have an important opportunity to recognize the progress made through both user fee programs and what these agreements can mean for patients,” said John Murphy III, president and CEO of AAM.

Murphy said that generic and biosimilar medicines are central to maintaining competition in the U.S. health care system and that GDUFA and BsUFA provide the FDA with resources and performance commitments needed to support predictable, science-based regulatory pathways.

The proposed GDUFA IV agreement includes changes intended to make the abbreviated new drug application (ANDA) assessment process more efficient and predictable. The changes are also designed to improve communication between the FDA and applicants, address scientific and regulatory questions earlier in the review process, and support the development of complex generics.

The proposal also seeks to better integrate inspections and manufacturing considerations throughout the application lifecycle to reduce unnecessary review cycles and support more timely generic drug approvals.

“Similarly, BsUFA IV represents an opportunity to continue modernizing the biosimilar development and review process,” Murphy said. “Greater regulatory efficiency, improved sponsor-FDA communication, appropriate use of advances in analytical science, and a predictable review process can reduce unnecessary development burdens while maintaining FDA’s rigorous standards for safety, purity, and potency.”

AAM and the Biosimilars Council said the two programs together reflect an ongoing effort by the FDA and industry to strengthen the regulatory framework for generic and biosimilar medicines.

“A strong FDA, adequately resourced and focused on efficient, science-based regulation, is essential to fostering competition and ensuring patients have timely access to safe, effective, and affordable medicines,” Murphy said.

AAM and the Biosimilars Council said they plan to work with Congress to secure timely reauthorization of both programs.