It was early November. The Food and Drug Administration had just endured the high-profile, dramatic exit of its top drug regulator. Personnel complaints had racked up. And other grievances within the agency that had already been rocked by layoffs and policy shifts continued to unfold.
Health Secretary Robert F. Kennedy Jr. summoned Food and Drug Administration Commissioner Marty Makary for a meeting, according to four individuals familiar with the matter. Kennedy told Makary to get his house in order, said one of the people, who like others spoke on the condition of anonymity to describe internal conversations or private discussions.
Kennedy, Makary and their aides discussed how to stabilize the agency, including shuffling Makary’s deputies or delegating some of his leadership responsibilities, three of the people said. The conversations were seen as constructive, they added, and some staffers hoped heading into the Thanksgiving holiday that the upheaval was behind the agency.
In the last week, the leadership turnover and public concern about the direction of the agency charged with overseeing the safety of vaccines, medications and most of the U.S. food supply has only grown. Another top leader has left and Vinay Prasad, the agency’s top vaccine regulator, detailed new vaccine approval changes that concerned public health experts.
The ongoing exits, negative headlines and other shake-ups at FDA have increasingly alarmed some drug-industry executives, public health experts and medical professionals who warn that it has left the agency increasingly fragile and threatens its mission. The drug industry relies on a predictable FDA to understand what it needs to do to win approval of new treatments, and executives fear instability at the agency could stymie advancements.
“We are at a tipping point,” John F. Crowley, the chief executive of the Biotechnology Innovation Organization, an industry trade group, said in a statement. “It is time to right this ship.”
Administration officials have held meetings at the White House this week to discuss the turmoil at FDA and how to address it, according to three people.
Richard Pazdur — the fifth person to lead the agency’s drug center this year — on Tuesday decided to retire after three weeks in the job over concerns about some of Makary’s plans to expedite drug approvals.
Prasad wrote an internal email the day after Thanksgiving that laid out dramatic changes to vaccine approvals, prompting a dozen former FDA commissioners to denounce his plans in the pages of the New England Journal of Medicine. The email — which the department has defended — was not cleared with Kennedy or the health department, and Prasad did not discuss it with the secretary, before it was sent last Friday afternoon, according to three people familiar with the matter.
The tumult at FDA follows upheaval the Centers for Disease Control and Prevention has faced for months, including the ousting of director Susan Monarez after less than a month in the job.
At the FDA, Kennedy has publicly lauded Makary and would like to see him succeed, according to two people familiar with the matter. But Kennedy has also privately raised doubts about whether Makary has the management skills to lead the agency, according to two individuals familiar with those conversations. The Wall Street Journal first reported discussions last month of potentially scaling back Makary’s role, citing complaints about his management style.
In a Cabinet meeting this week, Kennedy thanked President Donald Trump for empowering him and his deputies, naming Makary first in the list. In a social media post Thursday, Kennedy then thanked Makary for his leadership on the FDA’s efforts to crack down on the synthetic opioid derived from kratom leaf.
“Secretary Kennedy has full confidence in Dr. Makary to lead the FDA,” Andrew Nixon, a spokesman for the Department of Health and Human Services, said in a statement.
Makary has some high-level support in the White House, with chief of staff Susie Wiles and other officials praising his ideas to expedite drug reviews and other proposals that have begun to reshape the FDA, according to two people familiar with the matter.
“The White House maintains complete confidence in Marty Makary and the entire team at HHS and FDA,” spokesman Kush Desai said in a statement. “The near-weekly flow of groundbreaking FDA announcements – from removing artificial ingredients in our food supply to cracking down on animal testing to slashing burdensome red tape – is proof that Commissioner Makary and his team are delivering for the American people.”
But some Trump officials concede that Makary’s limited experience as an administrator has hampered his ability to run a sprawling government agency this year, with the longtime Johns Hopkins physician and professor now overseeing thousands of staff and an array of initiatives. Some top officials inside the FDA have also been alarmed by some of Makary’s signature efforts.
In early November, George Tidmarsh, the nation’s then-top drug regulator, resigned amid a probe into his critique of a treatment made by a company that alleged he had a vendetta against its board chair. Tidmarsh claimed the review was opened after he raised concerns about the legal basis of a new program to expedite some drug approvals. On Thursday, he declined to comment, telling The Washington Post he was not at liberty to speak.
Pazdur, who joined the FDA in 1999, was tapped to replace Tidmarsh and run the beleaguered Center for Drug Evaluation and Research, which regulates most prescription drugs and over-the-counter medicines. He had been viewed as a stabilizing force for the agency. His decision to retire three weeks later follows tensions with Makary, as Pazdur worried about the legality and pace of FDA initiatives to expedite drug approvals.
Pazdur also had serious concerns about Prasad’s leaked email, according to three people familiar with the matter. Prasad wrote, without detailing the evidence, that his team had concluded coronavirus vaccines had contributed to the deaths of at least 10 children.
Sen. Bill Cassidy (R-Louisiana), the chairman of the Senate’s health committee, and public health experts have called on the agency to release more details about how it performed its review or the process it used to verify the potential deaths.
Cassidy told The Post this week that while he had been more focused on the chaos at the CDC in recent months — including convening a hearing with Monarez to discuss her sudden ouster — his existing concerns about FDA have grown following Prasad’s email laying out changes to the vaccine-approval process. He declined to comment further, saying he hoped to learn more from his planned conversation with Prasad.
HHS said this week that officials will release data “soon” and called Prasad’s work a philosophical framework that moves the country to a “higher standard.”
“The American people deserve evidence-based science,” Nixon wrote.
Kennedy met with Pazdur on Wednesday, two people said. The meeting was cordial. Pazdur expressed concerns about the future of the agency, and Kennedy was aware of what had occurred in recent weeks. Kennedy didn’t try to change Pazdur’s mind about retiring. Axios first reported the meeting, which Nixon, the HHS spokesman, said was for Kennedy to thank Pazdur for his service.
“The agency has great respect for Dr. Pazdur and his decision to retire,” Makary wrote in an email to FDA staff Thursday obtained by The Post, praising Pazdur as an innovator who advanced care for “countless patients.”
He named Tracy Beth Hoeg — a prominent critic of broad childhood coronavirus vaccination before becoming one of his top deputies — as acting CDER director, saying she would assume the role in the coming weeks. Over the summer, she was involved in the investigation into reports of potential deaths from the vaccine.
Rick Weissenstein, an analyst at TD Cowen, said the churn represents “extraordinary turnover” for the drug center that has had only had a handful of directors in the last few decades.
“I think we need a tiny bit of stability,” Paul Hudson, the chief executive of Sanofi and board chair-elect of the drug lobby, Pharmaceutical Research and Manufacturers of America, said at an investor conference. “We have all of this drama with vaccines. We have all of this drama now with CDER. Do we really know what the new FDA looks like and how they operate?” A recording was provided by S&P Global Market Intelligence.
The changes could make it harder for the drug industry to predict what the criteria will be to bring new treatments to the market, some former FDA officials said.
“To put that together, you have to count on stability,” said Howard Sklamberg, a partner at the law firm Arnold & Porter who worked at the agency for seven years. “Because you have to able to, in your planning, think not just what the agency’s standards are for that particular drug now, but what they will be five years from now or 10 years from now.”
Several FDA staffers said morale plummeted after Pazdur’s decision to retire and more people may look for the exits as Hoeg, a sports medicine physician and epidemiologist, takes the reins as the acting head of the drug center.
The day after Pazdur said he was retiring, Theresa Michele was removed from her position as head of the office of over-the-counter drugs and moved to the medical device center, according to two people familiar with the matter who spoke on the condition of anonymity to discuss personnel matters. The move, which was first reported by Stat, shocked some staff, and Pazdur had previously fought against the switch, one of the people said. Nixon said Michele, who did not return a request for comment, was joining the leadership of the medical device center.
Daniel Gilbert contributed to this report.
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