A Top FDA Scientist Who Quit Warns of Politicized Drug Approvals

BY LIZ ESSLEY WHYTE

WASHINGTON—Dr. Richard Pazdur, a top federal drug regulator, wasn’t on board.

He and lawyers from the Department of Health and Human Services objected to a press release from Food and Drug Administration Commissioner Marty Makary containing a proposal to require only one clinical trial for drug approvals, down from the usual two.

“All of a sudden, I was given a press release with a quotation by myself written in it, and asked to just agree to it,” Pazdur said in an interview with The Wall Street Journal.

Without addressing Pazdur’s concerns, Makary went public with the proposal.

Pazdur said that under Makary, fast-track drug approvals had been politicized in a way he had never experienced in his 26 years at the agency. Past FDA commissioners carefully avoided interfering in individual drug approvals, instead letting the scientific reviewers have sway. “This wall between the commissioner’s office and the review staff has been breached,” Pazdur said.

That incident and other frustrations led to Pazdur’s abrupt departure in December. He announced he would retire from his role as head of the agency’s drug division less than a month after Makary and Health Secretary Robert F. Kennedy Jr. tapped him to lead it. As the FDA’s drugs chief, Pazdur was responsible for thousands of employees overseeing most of the new medicines the FDA weighs for approval, as well as over-thecounter and generic drugs.

Pazdur is now sounding alarm bells about Makary’s leadership. “We have an unclear future of what the FDA will be,” he said.

HHS spokesman Rich Danker said “the FDA needed urgent reform and Dr. Makary— with his clinical experience in treating cancer patients— leads the agency with a profound sense of urgency in delivering cures to the American people.” Danker added that “every FDA drug approval or rejection decision under Dr. Makary’s leadership has represented the recommendation of each primary review team of career scientists.”

Danker said Pazdur was indecisive about the proposal to move to one clinical trial.

The FDA’s powerful drug division has had five leaders in the past year, contributing to an unprecedented level of turmoil at the agency responsible for ensuring the drugs Americans take are safe and effective. In addition to the drug division turnover, the FDA’s vaccines chief was ousted by Kennedy, and his successor, Dr. Vinay Prasad, was fired and rehired after initially sparking concern at the White House.

On Thursday, the White House and Kennedy shook up the top ranks of HHS, the FDA’s parent agency. Some new top lieutenants will have roles managing the FDA. Danker said Makary’s first year in office had been successful.

Pharmaceutical industry leaders had publicly hailed Pazdur’s appointment as drugs chief, praising his years of expertise and scientific acumen, and were dismayed by his departure. Pazdur was respected and brought “institutional memory that I think is very important for regulation,” said Baird analyst Brian Skorney. When Pazdur left, “it was an extraordinary red flag.”

Pazdur, an oncologist, scrutinized applications for cancer treatments for more than a quarter of a century at the FDA before leading its drug division. He was known for evolving from a conservative stance—hesitant to grant approvals— to finding new ways to push new drugs out faster. That is because the past two decades have brought scientific advancements that made new cancer drugs much better, Pazdur said.

After Makary’s initial pick for the top drug regulator at the FDA, Dr. George Tidmarsh, was accused of using his position to try to sink a rival’s company and solicit a bribe, Makary was under pressure to appoint a steady hand to the role, people familiar with the matter said. At the time, Kennedy was weighing installing a new leader for the FDA, leaving Makary to be more of a figurehead, the Journal previously reported.

Makary visited Pazdur in his Bethesda, Md., home and stood by his kitchen counter as he promised that the cancer doctor would get a say in key decisions at the agency, Pazdur said. Despite being the agency’s top cancer regulator, Pazdur had worked with Makary very little before that meeting, Pazdur said, and had to ask Makary for his phone number.

Pazdur was deeply bothered by Makary’s plan to approve drugs with only one clinical trial, without additional evidence to show drugs work, and was worried that FDA staff hadn’t had a chance to weigh in. “One cannot develop policy in a press release,” he said.

He alleged the agency has been politicized by a new program launched by Makary to give speedy reviews to certain handpicked companies that are meeting “national priorities” such as lower drug prices or domestic manufacturing. Danker said the program “has the potential to dramatically reduce review times.”

Pazdur warned: “If we have another administration come in that may be of a different political persuasion and just change everything back, it’s just going to lead to massive inconsistencies.”