Top FDA official Pazdur raises alarm about expediting approvals, Washington Post reports

Audio By Carbonatix

Enlarge

(Reuters) -The U.S. Food and Drug Administration’s new head of the drug evaluation department, Richard Pazdur, has raised concerns about the legality and pace of new initiatives to expedite decisions, the Washington Post reported on Friday, citing three people familiar with the matter.

The agency’s veteran oncology chief Pazdur took over the new role earlier this month, replacing George Tidmarsh, who resigned amid serious concerns about his personal conduct.

Pazdur has questioned several plans developed by FDA Commissioner Marty Makary, warning that they could pose a risk to public health, the report added.

The two have disagreed over the commissioner’s plan to reduce the number of research studies needed to justify more drug-related decisions, such as changes to drug labels, the report said, citing two people.

Pazdur has argued that Makary’s new drug-review program, which is part of President Donald Trump’s initiative to reduce drug prices and boost U.S. drug manufacturing, lacks sufficient transparency and could be illegal, the report said.

The program shortens the review time and expedites approvals for treatments that are aligned with the country’s health priorities.

He has also pushed back against Makary’s plan to exclude career scientists from discussions on politically driven priorities, arguing that their involvement is crucial to maintain a safe and transparent review process, the report added.

The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for comment.

(Reporting by Sriparna Roy and Padmanabhan Ananthan in Bengaluru; Editing by Leroy Leo)