The top US drug regulator signaled on Tuesday that he could resign within weeks of taking the job, adding coup in high circles US Food and Drug Administration (FDA).
If Richard Pazdur resigns, finding a replacement will be difficult amid mounting political pressure and internal conflict at the agency, the people said.
“Who else was left? He was the only person who was identified,” said Janet Woodcock, former acting FDA commissioner. “There have been a lot of departures, and now, with all this turmoil, it will be difficult to find a replacement.”
Filing paperwork is the first step toward retirement, but Pazdur may still decide to stay with the agency.
Pazdur, a longtime FDA employee and respected oncology expert, was expected to bring some stability to the agency after a year of turmoil and tension. He is the fourth director of the Center for Drug Evaluation and Research (CDER) this year. as reported initially rejected this position, but then accepted it at the urging of FDA Commissioner Marty Macari.
Previous head of the Center George Tidmarshreportedly left after a lawsuit alleged he retaliated against a former business partner over regulatory decisions. Tidmarsh claimed he was ousted because he questioned a new system for fast regulatory decisions, the Commissioner's National Priority Voucher.
Tidmarsh also clashed with Vinay Prasad, who is both the director of the Center for Biologics Evaluation and Research (CBER) and the FDA's chief medical and scientific officer. Prasad himself was briefly forced out and then returned to the FDA in the summer.
“There’s a lot of conflict going on,” Woodcock said. “When you're asked to deal with this and do all these new things at a time when a lot of people have left, resigned, been forced to leave, it's a very difficult problem.”
Pazdur was expected to lead the commissioner's new rapid approval program (think Shark Tank for drug regulatory decisions), but few planned to launch the program.
“The plan was that Dr. Prasad and company would assemble a panel and simply say yes or no, like the Romans at the Colosseum, giving a thumbs up or thumbs down,” Woodcock said. “And it’s not an orderly process.”
Typically, regulatory decisions are made by career bureaucrats rather than senior executives to avoid the appearance of politicization. The one-day meetings also raised concerns about regulators' ability to review applications and thoroughly document their decisions.
Pazdur has applied for retirement, confirmed Emily Hilliard, a spokeswoman for the U.S. Department of Health and Human Services (HHS).
“We respect Dr. Pazdur’s decision to retire and recognize his 26 years of distinguished service to the FDA,” Hilliard said.
Pazdur did not respond to questions from the Guardian about his plans.
It is possible that Pazdur will not decide to retire. Resigning from the U.S. government is a long and bureaucratic process, and it's best to do it before the start of the new year, Woodcock said, so he can possibly file to keep his options open.
“Maybe he will retire, but I don't think it's a good time yet,” Woodcock said. “He's obviously given it some thought, and the situation means he's probably more than giving it some thought. He's probably really tempted.”
Uncertainty about who will lead the regulatory body has long-term consequences for public trust and the future of drug development.
Members of the public “want to be confident that predictable decisions are being made, and the pharmaceutical and other industries need predictability because they are investing or taking on enormous risks,” Woodcock said.
