PDUFA Date Changes Expected, Many Agreed With RFK Jr. About the FDA, Survey Finds | MHE 2025 Pharmacy Survey, Part 2

A large majority of the respondents to our annual Managed Healthcare Executive (MHE) Pharmacy Survey expect FDA drug approval decisions to be delayed because of staffing cuts at the agency.

Two-thirds (66%) of the respondents to the MHE survey said they expect Prescription Drug User Fee Act (PDUFA) dates to be delayed because of Department of Government Efficiency (DOGE) staffing cuts at the FDA, while 26% indicated they didn’t expect delays and the remaining 8% weren’t sure.

PDUFA dates are target dates for the FDA to make an approval decision about a new drug. They are closely watched by drugmakers and those who follow the industry.

We conducted our annual Managed Healthcare Executive Pharmacy Survey from March 10 through April 9, 2025. With some help from our colleagues at The American Journal of Managed Care, we had results from 123 respondents. The respondents were spread fairly evenly across the segments of the U.S. healthcare sector, with approximately a quarter indicating that they worked for a provider, a quarter indicating that they worked for a payer, and a slightly smaller proportion (22%) indicating they worked in higher education.

HHS Secretary Robert F. Kennedy Jr. has said the DOGE staffing cuts would not affect FDA drug reviewers, but news reports have said some reviewers are leaving their jobs because of turmoil at the agency stemming, in part, from the cutbacks. More recent reports say some of the staffing cuts may be reversed, and Kennedy said during his congressional testimony last week that “we understood that there would be some mistakes made, and that we would go back and reverse them when they were made.” Kennedy added, though, that “it was more important to take decisive action quickly that could eliminate the metastasizing of this agency growing and going as our health declined.”

There is a populist streak to Kennedy’s views on healthcare and the federal government’s role as funder and regulator. During his congressional testimony last week, he spoke about the corruption and corporate capture of the National Institutes of Health, and he has painted the FDA with the same brush. Respondents to our survey share some of Kennedy’s populist views about FDA. Close to two-thirds (64%) said they agree that the FDA’s independence had been negatively affected by “corporate capture” and conflicts of interest, 30% disagreed and 6% weren’t sure.