FDA drug chief signals possible exit as agency turmoil deepens

The top drug regulator in the US signaled on Tuesday he may retire weeks after accepting the position, adding to upheaval in the highest ranks of the US Food and Drug Administration (FDA).If Richard Pazdur retires, finding a replacement would be challenging amid mounting political pressure and internal conflict at the agency, sources say.“Who else is left? He was the one person who was identified,” said Janet Woodcock, former acting commissioner of the FDA. “There’s been a lot of departures, and it would be hard to find a substitute now with all this turmoil.”Filing papers is the first step for retiring, but Pazdur could still choose to stay at the agency.Pazdur, a longtime FDA official and respected oncology expert, was expected to bring some stability to the agency after a year of turmoil and tension. He is the fourth leader of the Center for Drug Evaluation and Research (CDER) this year, and he reportedly turned down the position at first but then accepted it at the urging of the FDA commissioner, Marty Makary.The previous chief of the CDER, George Tidmarsh, reportedly left after a lawsuit alleged he was retaliating against a former business partner in making regulatory decisions. Tidmarsh has maintained that he was pushed out because he questioned a new system for quickly making 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 chief medical and scientific officer at the FDA. Prasad himself was briefly pushed out and then brought back to the FDA over the summer.“There’s lots of conflict going on,” Woodcock said. “Being asked to manage through that and do all these new things in the time when a lot of people have left, resigned, been forced out – it’s a very hard problem.”Pazdur was expected to run the commissioner’s new rapid approval program – think Shark Tank for drug regulation decisions – but there has been little planning to get the program off the ground.“The plan was that Dr Prasad and company would have a panel and just go ahead and say ‘yay’ or ‘nay’, like the Romans at the Coliseum, thumbs up or down,” Woodcock said. “And that’s not an orderly process.”Typically, career officials, not top leaders, make regulatory decisions in order to avoid the appearance of politicization. The one-day meetings also led to concerns about regulators’ ability to examine applications and document their decisions thoroughly.Pazdur has requested retirement, Emily Hilliard, a spokesperson for the US Department of Health and Human Services (HHS), confirmed.“We respect Dr Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” Hilliard said.Pazdur did not respond to the Guardian’s questions about his plans.It’s possible that Pazdur will not choose to retire. Filing for retirement from the US government is a long and bureaucratic process, and it’s better to do it before the start of the new year, Woodcock said – so he may have filed the papers in order to keep his options open.“Maybe he will retire, but I don’t think it’s a slam dunk yet,” Woodcock said. “Obviously he’s been considering it, and the situation means he’s probably more than considering it. He’s probably really tempted.”The uncertainty about who will lead the regulatory agency has long-lasting effects on public trust and the future of drug creation.Members of the public “want to be confident that predictable decisions are being made, and pharmaceutical and other industries need predictability because they’re investing or taking huge risks”, Woodcock said.