Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several FDA initiatives seeking to shorten the drug review process.
Richard Pazdur, an FDA veteran appointed director of the Center for Drug Evaluation and Research earlier this month, has questioned the legality of the agency’s push to expedite drug approvals and argued that it could put patients at risk, sources tell The Washington Post.
Citing three sources who were granted anonymity, the Post on Friday reported that Pazdur and FDA Commissioner Marty Makary have been butting heads over several of the latter’s plans to speed up approvals and labeling adjustments, including shortening review periods and lowering the number of studies required.
Pazdur has also taken issue with the new Commissioner’s National Priority Voucher program, which aims to shorten the review period from the usual 10-12 months to 1–2 months. This privilege is granted to companies that align with certain national priorities of the Trump administration, such as lowering drug prices and boosting domestic manufacturing.
Aside from the expedited approvals, Pazdur has also criticized Makary’s planned exclusion of scientists from discussions regarding politically charged health issues, the Post reported.
Tensions between Pazdur and his boss have been high since these disagreements, two sources told Endpoints News. The outlet reported on Monday that Makary and his deputy haven’t spoken to each other since the Post story broke.
In a statement given to Endpoints by a spokesperson for the Department of Health and Human Services, Makary called Pazdur a “true regulatory innovator” who helps “guide our broader agenda to modernize the agency and streamline the approval process.” The spokesperson also provided a statement from Pazdur, who said that he remains “committed to the mission of CDER and my current position.”
Pazdur was named CDER director on Nov. 11 following what appeared to be a lengthy courtship process, which reportedly involved Makary spending hours at Pazdur’s house, assuring him he would have independence in his new post. The oncologist, who has been with the FDA since 1999 and was most recently chief of its Oncology Center of Excellence, had originally declined the CDER directorship.
Pazdur succeeds George Tidmarsh, who resigned from his post earlier this month amid an internal probe regarding his personal conduct. Tidmarsh had been on the job for just over three months. In July, Vinay Prasad, top biologics regulator at the FDA, also left the agency under mysterious circumstances but was reinstated 10 days later.
This leadership shuffle has led some White House officials to question Makary’s effectiveness as a leader, with some even suggesting curtailing his role at the FDA and finding another officer to be in charge of the agency, according to The Wall Street Journal.
