Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.
Key Takeaways
- Richard Pazdur, the FDA’s longtime oncology leader, is planning to leave the agency at the end of December, about one-and-a-half months after he became CDER director.
- Pazdur and FDA Commissioner Martin Makary reportedly clashed despite the Makary’s assurances that there would be no political interference in CDER’s operations.
- The biopharma industry and its investors appear to be growing weary of the leadership turmoil. BIO framed the situation as a weakness that could be exploited by foreign adversaries like China.
Richard Pazdur’s retirement leaves the US Food and Drug Administration searching for its fifth Center for Drug Evaluation and Research director in less than a year, with no obvious internal successors, and creates more uncertainty for drug manufacturers, patients and the agency’s own beleaguered staff.
The departure also creates an embarrassing situation for Commissioner Martin Makary, who personally lobbied Pazdur to take the job, only to see him depart weeks later when Makary’s assurances that he would not encounter political interference while running CDER fell flat.
Makary and Center for Biologics Evaluation and Research Director Vinay Prasad, who also serves as chief medical and scientific officer, could find their jobs threatened as industry frames the leadership turmoil as a national security risk.
The Biotechnology Innovation Organization, an industry trade group, called the FDA leadership upheaval over the past 12 months a weakness that foreign adversaries will exploit, an argument that could gain traction on Capitol Hill and at the White House.
“This constant turmoil is undermining America’s leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China,” BIO said. “As BIO has long upheld, it is imperative that we retain and recruit scientific expertise and strong leadership of the highest caliber at our health agencies and that the standards that are the hallmark of these health institutions are upheld and advanced.”
“We are at a tipping point. It is time to right this ship,” the group said.
In a Dec. 2 note, Raymond James analyst Chris Meekins, who praised Pazdur’s appointment just weeks earlier, said his departure “will likely cause significant concerns for investors who care about innovation in the space.”
“The reality is that FDA has more drama than the Real Housewives shows and at some point, political leaders at HHS or the White House will have had enough,” Meekins said. “We may be approaching that point where Prasad and/or Makary’s future is in question.”
Departing End Of December
Pazdur, the FDA’s longtime oncology leader, is planning to leave the agency at the end of December, about seven weeks after he took over as CDER director, sources familiar with his plans confirmed. News of his retirement plans was first reported by STAT.
Pazdur, a 26-year agency veteran, was oncology division director before he was named the first director of the Oncology Center of Excellence in 2016. His decision to accept the CDER director’s position after initially turning it down was met with relief among agency employees, the biopharma industry and patient groups, who welcomed his years of experience, steady hand, and innovative regulatory approaches.
In contrast, Pazdur’s decision to retire has been met with shock and dismay internally and externally.
Pazdur “exemplifies the type of expert and steady leadership that has made the United States the home to the world’s leading medical breakthroughs,” BIO said. His departure “raises serious concerns about the repeated turnover in key leadership occurring at the FDA.”
“Rick Pazdur’s evidence-based innovative track record speaks for itself,” said Ellen Sigal, chair and founder of Friends of Cancer Research. “This is a huge loss for patients, for science and for all Americans.”
Although Pazdur submitted his retirement papers, they are revocable until the date of departure.
Some external stakeholders questioned whether his move was intended to increase his leverage and pressure on Makary and Prasad. However, Pazdur is expected to follow through with his plans.
“We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” an HHS spokesman said. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients. His leadership, vision, and dedication will continue to shape the FDA for years to come.”
Voucher Program A Source Of Conflict
Pazdur had raised concerns about Makary’s new Commissioner’s National Priority Voucher program, which promises a one- to two-month review for products that align with US national health priorities.
Former CDER Director George Tidmarsh also reportedly raised concerns about the legality of the program.
Tidmarsh resigned Nov. 2 after less than four months in the job and two days after being put on administrative leave amid concerns about his conduct.
Tidmarsh replaced Jacqueline Corrigan-Curay, who was acting CDER director following the January departure of Patrizia Cavazzoni.
Lawmakers on Capitol Hill also have objected to the CNPV program.
In a Nov. 20 letter to Makary, House Energy and Commerce Committee Ranking Member Frank Pallone, D-NJ, and Senate Health, Education, Labor and Pensions Committee Ranking Member Bernie Sanders, I-VT, said they had significant concerns the program “will enable corruption by creating a new, lucrative gift for drugmakers and allies politically favored by President Trump.”
“We also fear the addition of yet another expedited review program, particularly one with absurdly short timelines that are inconsistent with those in the user fee agreements,” the lawmakers wrote.
Sources also said Pazdur objected to Makary’s attempt to install new leaders atop some review offices within CDER.
“If Makary is pushing any changes in CDER personnel from above and essentially over Pazdur’s head, it would not be surprising that Pazdur is having none of it,” a food and drug regulatory attorney said. “Especially as it is believed that he extricated promises for no political interference in running CDER as part of his taking on the CDER director role.”
When Pazdur took the CDER director position, observers predicted tension could emerge with Prasad, who publicly criticized Pazdur’s approval of cancer drugs based on surrogate endpoints before joining the agency.
During an FDA Direct podcast posted on Nov. 12, Prasad said he and Pazdur were working well together.
More Retirements On The Horizon?
The FDA once again must find a leader for its largest product center, which is already reeling from leadership upheavals, layoffs and widespread employee departures.
Just days before Pazdur agreed to take the CDER director’s job, Principal Deputy Commissioner Sara Brenner said in an email to staff that the agency was conducting a “competitive search” for the next director and that employees should email their curriculum vitae if they were interested in the position.
CDER Deputy Director Mike Davis could become interim director following Pazdur’s departure, although after Tidmarsh left it was unclear who, if anyone, was running the center.
Makary could opt to make Prasad the acting head of CDER, in addition to his CBER duties. Tidmarsh was acting head of CBER when Prasad was briefly ousted in July.
The challenge in filling the post after Tidmarsh left, and the repeated outreach to Pazdur, suggests there are few, if any, obvious internal candidates for the job.
Another expected wave of staff retirements in December and January will further complicate the selection of an internal candidate, said Howard Sklamberg, a partner at Arnold and Porter in Washington DC. He said early January is the best time to retire from the FDA in terms of maximizing a financial package.
“The known unknown coming up is who else will leave,” Sklamberg said. “I suspect we will see a lot more retirements in the next month or six weeks … I don’t know who will be in the mix.”
The lack of an obvious internal candidate could increase the odds Makary looks outside the agency, although he already tried that route with Tidmarsh. The move backfired after Tidmarsh criticized the approval of certain drugs on social media.
“The irony of this latest disaster at the FDA is that Dr. Makary and Dr. Prasad both came to the FDA saying that they would strengthen the scientific evidence required at the FDA compared to the standards in previous years, including standards set by Dr. Pazdur, but in recent months both have gone in the opposite direction,” said Diana Zuckerman, president of the National Center for Health Research. “This is just the latest sign that scientific differences of opinion are no longer acceptable at the FDA, especially if they conflict with what the White House wants.”
Malcolm Spicer contributed to this story.