Hahn Stresses He Won’t Overrule Career Scientists’ COVID-19 Vaccine Decisions

FDA Commissioner Stephen Hahn made clear on Thursday that he will not intervene in any decisions made by career staff on COVID-19 vaccine approvals, even though he has the authority to overrule them.

Hahn explained that after phase 3 trial results are released for a COVID-19 vaccine and they’re discussed at a public advisory committee meeting, the agency’s Center for Biologics Evaluation and Research (CBER) and its director, Peter Marks, will make any approval decision.

Hahn does legally have the power to override Marks’ conclusions, but he said he would not because of his “complete and absolute confidence in the scientists at FDA and the decision-making that they have here.”

“I will be briefed as the commissioner all along about this. I will have the opportunity to see the data,” he said, speaking at a virtual meeting of the Economic Club of Washington. “I can tell you throughout this pandemic, throughout my tenure as commissioner, I have not reversed a decision by the career scientists on medical products, and I have no intention of doing that now.”

When asked to give an estimated arrival date for a vaccine, Hahn demurred, noting that the agency has not yet seen the late-stage trial data.

“It would be really inappropriate for me to speculate,” he said. “Those clinical data are going to come from trials that an independent safety data monitoring board’s going to advise a company about, and then [FDA] will receive it. We’re going to call the balls and strikes on the data on safety and efficacy, and we’re not going to cut corners on that.”

Eight senior FDA career executives — including Marks, Associate Commissioner for Regulatory Affairs Judy McMeekin, Center for Drug Evaluation and Research (CDER) Deputy Director Patrizia Cavazzoni, and Janet Woodcock, who has temporarily left her position as director of the Center for Drug Evaluation and Research to focus on COVID-19 as part of the Trump administration’s Operation Warp Speed initiative — also spoke out Thursday in a USA Today op-ed to assure the public that science is the only factor in FDA decisions.

The executives, who were joined by the heads of the agency’s medical device, veterinary drug, food and tobacco products centers, acknowledged that the FDA “operates in a political environment” but contended that it makes its decisions solely using unbiased assessments of scientific evidence.

“Maintaining the American public’s trust in the FDA is vital. If the agency’s credibility is lost because of real or perceived interference, people will not rely on the agency’s safety warnings,” they said. “Our approach has been and must remain the gold standard that all can rely upon.”

A tagline on the piece said that the views expressed in the article were independent of the FDA, HHS or the federal government. — James Miessler