Reforming the Prescription Drug User Fee Program

Ziaks, Therese J. M.S., M.P.H.
Schwartz, Jason L. Ph.D.
Ross, Joseph S. M.D., M.H.S.
Ramachandran, Reshma M.D., M.P.P., M.H.S.

¹Yale School of Public Health, New Haven, CT
²Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, CT
³Department of Health Policy and Management, Yale School of Public Health, New Haven, CT
⁴Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT

This article was published on August 16, 2025, at NEJM.org.

Disclosure forms provided by the authors are available at NEJM.org.

New England Journal of Medicine 393(8):p 734-736, August 21, 2025. | DOI: 10.1056/NEJMp2507648

Reforming the Prescription Drug User Fee Program

The FDA has begun soliciting feedback to inform the next version of the Prescription Drug User Fee Act. User fees remain critical for supporting regulatory operations, but the program's future is unclear.