Top FDA drug regulator raises alarms about expediting approvals

The newly installed top U.S. drug regulator has raised concerns about the legality and pace of initiatives to expedite drug decisions, arguing they could threaten Americans’ safety, according to three people familiar with the matter who spoke on the condition of anonymity to detail private deliberations.

Richard Pazdur, an oncologist and longtime Food and Drug Administration official who was announced for his new role on Nov. 11, has questioned several plans developed by FDA Commissioner Marty Makary, warning that they could pose a risk to public health, the people said. His concerns, which have not previously been reported, represent the latest flash point at an agency rocked by turmoil this year amid layoffs and the exits of some senior staff. Industry groups this week also appealed to President Donald Trump, saying that FDA’s regulatory decisions had become erratic and unpredictable, casting a shadow over the agency’s drug approvals and creating uncertainty for patients.

Pazdur and Makary 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, two of the people said. Makary has argued his plan to reduce the burden of proof to a single study would allow the agency to more quickly respond to new evidence. Pazdur has countered that multiple studies may be necessary in many cases and would better protect public health.

Pazdur has also raised concerns about Makary’s new drug-review program, which has been part of Trump’s push for lower drug prices and efforts to boost domestic manufacturing. Pazdur told colleagues the program – which allows the agency to significantly shorten review times and expedite approvals for treatments that are aligned with the country’s health priorities – is not sufficiently transparent and could be illegal, the people said. The Trump administration has partly leaned on the program as it seeks to strike deals with drug companies to voluntarily cut their prices in exchange for quick drug approvals and other benefits.

Pazdur has also pushed back on Makary’s plans to exclude career scientists from matters that address political priorities, arguing that their involvement is essential to ensure a safe and transparent drug-review process, two people said. Makary has been seeking rapid changes to agency regulations that affect antidepressant medications, puberty blockers and psychedelics, among other priorities. The commissioner has also questioned whether some career scientists are impeding that agenda and should be reassigned, the people said.

Pazdur, who has worked at the FDA since 1999, has been viewed as a stabilizing force for the agency in his new role leading the Center for Drug Evaluation and Research. His predecessor, George Tidmarsh, resigned on Nov. 2 amid scrutiny and a lawsuit over his critique of a treatment made by a company that alleged he had a vendetta against its board chair.

“Regarding my management style, I am not a micromanager,” Pazdur wrote to staff after his appointment in an email obtained by the Washington Post. “I trust those who report to me to excel in their roles.”

As tensions immediately emerged with the commissioner, Pazdur privately mused about retiring or returning to his old job overseeing the FDA’s oncology center, according to two of the people who have spoken with him. But another person close to Pazdur said he has no plans to resign his post or depart the agency despite the tensions.

Pazdur said in a statement through an HHS spokesman that he remains committed to the drug center’s mission and his current position.

Makary said in a statement through an HHS spokesman that Pazdur is “a true regulatory innovator who is helping guide our broader agenda to modernize the agency and streamline the approval process.”

Some of Pazdur’s concerns echo objections raised by his predecessor Tidmarsh, who told the New York Times that the new drug-review program to expedite approvals would “basically change the entire paradigm of the legal underpinnings of drug approvals” that have existed for decades. Reached by phone briefly this month, Tidmarsh confirmed his comments to the Times.

The White House defended Makary, touting his work on baby formula and other priorities.

“The FDA under Commissioner Makary’s leadership has smashed a broken status quo and overseen one historic MAHA initiative after another, from launching Operation Stork Speed to expanding Hormone Replacement Therapy to dropping artificial ingredients from our food supply,” spokesman Kush Desai said in a statement.

Makary has overseen several personnel shake-ups, including weeks of scrutiny around Vinay Prasad, a top deputy and vaccine regulator who briefly left the agency this summer amid attacks from some conservatives. Makary successfully appealed to the White House to bring back Prasad. The FDA commissioner also sought to promote his ally Sanjula Jain-Nagpal to become his deputy chief of staff but was told by the White House that she could not hold that role. Jain-Nagpal subsequently used the title in conversations, prompting a demand from the White House this week that she be fired.

A White House official said that the demand to fire Jain-Nagpal, which was first reported by Politico, had been retracted after administration officials learned that she had not been informed of their objections and was not deliberately defying their request. The official spoke on the condition of anonymity to discuss a personnel matter. Jain-Nagpal did not immediately respond to a request for comment.

The drug industry relies on a predictable FDA to understand what it needs to do to win approval of new treatments and has recently raised concerns publicly, including in a letter directed to Trump, Makary and Health Secretary Robert F. Kennedy Jr.

“Mr. President, recent FDA actions risk undermining your legacy of medical innovation,” biotechnology companies, rare disease patient advocates and investors wrote, warning that China could displace America’s global leadership in the biotechnology field. Another letter from biomedical investors and executives posted publicly this week said that the agency’s communications had become erratic and were harming their ability to bring new drugs to market.

In a statement, a spokesman for HHS said the agency “strongly disagree[s]” with the premise that FDA decisions are unpredictable.

“Regulatory requirements may evolve as new data emerge, but this reflects a rigorous, science-driven review process, not inconsistency,” Rich Danker, an HHS spokesman, wrote in an email. “Early feedback to sponsors is informative, not binding, and each application is evaluated on the merits of safety and efficacy.”