FDA Commissioner Marty Makary spent hours over the weekend at Rick Pazdur’s house trying to convince the agency’s longtime cancer chief to step up to the role of top drug regulator, a source familiar with the matter told Endpoints News.
Part of that discussion involved Makary assuring Pazdur that as director of the Center for Drug Evaluation and Research, he would have autonomy and independence from biologics director Vinay Prasad, according to the person, who spoke on condition of anonymity. Prasad has feuded with past FDA leaders, overruled CBER review staff, and specifically targeted Pazdur online before Prasad’s time at the FDA.
The decision by Pazdur to take the job, after denying it initially, makes him the fourth CDER director of 2025 — following George Tidmarsh’s recent resignation, Jacqueline Corrigan-Curay’s brief tenure as acting director, and Patrizia Cavazzoni’s departure in January before joining Pfizer. Pazdur’s first email to staff on Wednesday suggests he knew what he was getting into.
In an email obtained by Endpoints, Pazdur told CDER staff that he’s “not a micromanager.” He also noted, “it is common for drug companies to lobby me regarding their side of an issue. My response is simple: Contact the review team and I will be happy to attend meetings with all parties. This also holds for our internal disagreements; I believe there are always two sides to every issue.”
Pazdur enters the FDA’s upper echelon of leadership at a time when the agency has lost thousands of staff (including key leaders), morale is low, and the agency has adopted a deregulatory agenda. His appointment has made some employees ready to put the more turbulent past aside. But his tenuous relationship with Prasad could continue after the infighting that occurred between Prasad and Tidmarsh.
A CDER division director who requested anonymity out of fear of retribution told Endpoints that Pazdur is the best possible result for the center. Another CDER physician said staffers are tired of all the drama. In addition to Pazdur’s initial decision to not take the CDER job, new OND Director Mary Thanh Hai rejected it too, and FDA Deputy Director Sara Brenner sent an email to some leadership asking if they were interested in the role, according to a CDER source.
An HHS spokesperson said in a statement that selecting Pazdur for the CDER job involved a “series of discussions that ultimately led to Dr. Pazdur’s acceptance.”
“We are confident that his 26 years of experience at the FDA will be instrumental as we work to bring greater accountability and transparency,” the spokesperson said.
Prasad vs. Pazdur
Pazdur’s interest and ability to speed up cancer drug reviews, work in a bottom-up environment, and be transparent at adcomms has made him a model for the rest of the agency.
“I believe that novel ideas should come from our daily review work — meaning they should come from you. This is a bottom-up, rather than a top-down management style, the former being the best type of management,” Pazdur wrote in his email to CDER staff on Wednesday.
Prasad, meanwhile, has overruled CBER reviewers on Moderna’s Covid-19 vaccine, and during his tenure, recently issued complete response letters for experimental drugs in development from Capricor, Ultragenyx and Replimune that caught some of the companies off-guard. Capricor’s advisory committee meeting was reportedly canceled by Prasad just prior to the CRL, and Replimune CEO Sushil Patel said he was “surprised” by the CRL, saying the issues in it were not highlighted during the FDA’s mid- and late-cycle reviews.
Prasad has criticized Pazdur in the past, including his ability to speed up cancer drug approvals.
Before joining FDA, Prasad sent a series of Twitter posts pointing at Pazdur directly. One post from 2022 on the platform, now known as X, says, “Rick Pazdur has too much control over cancer drug policy.”
In another tweet from 2024, Prasad responded to a tweet from the FDA celebrating Pazdur’s 25th work anniversary, writing, “25 years of the bar getting lower. Pharma getting richer. Drugs costing more.”
Prasad did not respond to a request for comment.
Former FDA Commissioner Rob Califf told Endpoints that Pazdur is “a man of great integrity, he understands regulation and clinical evidence and he has nothing to prove, so I’m hopeful.”
Ellen Sigal, chair and founder of the nonprofit Friends of Cancer Research — which has championed Pazdur at its annual conference over the years — told Endpoints that “Pazdur’s decision to take on this role reflects exactly who he is, a lifelong public servant committed to strengthening the FDA and improving patients’ lives.”
Max Bayer contributed reporting.
https://endpoints.news/pazdur-vs-prasad-can-the-cder-cber-dynamic-change-under-new-leadership/