FiercePharmaPolitics—FDA official leaves 'Warp Speed' to preserve independent regulatory power: report

FDA Building
An FDA official returned to his job after a short stint participating in Operation Warp Speed. (FDA)

Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate.

As researchers worldwide race forward with COVID-19 vaccines, one influential expert has departed the United States’ Operation Warp Speed over concerns of political pressure playing into regulatory decisions.

Peter Marks, who runs the Center for Biologics Evaluation and Research at the FDA, had been part of the group but stepped down after several days of work on the project, sources told Politico. A memo said the White House had found enough other experts for the Warp Speed work, Politico reports, but a source told the publication Marks actually "quit in disgust." 

Operation Warp Speed aims to deliver a COVID-19 vaccine to Americans by the end of the year, and President Donald Trump recently named former GSK exec—and former Moderna board member—Moncef Slaoui to lead the group.

Only days after joining the group, Marks realized he’s better suited to CBER, which will make final regulatory decisions on any of the vaccines in development, Politico reports. By exiting Warp Speed and focusing on his FDA job, Marks will be in a better position to resist political pressure on COVID-19 vaccine decisions at the agency, sources told the publication.

That decision came after a tense meeting during which White House coronavirus coordinator Deborah Birx pressed Marks for answers about which vaccines the government was prioritizing and funding, according to the report. As CBER director, Marks doesn’t make those calls. The two patched up the misunderstanding, according to Politico’s sources, but Marks realized he’s better off returning to his FDA job. 

"I believe that the American public will be best served by my return full time to FDA, where I can continue to work collaboratively, with industry, government partners and other researchers and provide regulatory advice to expedite the development and availability of vaccines to combat COVID-19," he said in a statement to Politico. 

RELATED: Ousted BARDA director pushed back on chloroquine claims and faced whistleblower retaliation, complaint says

Meanwhile, University of Pennsylvania professors are worried about an “October surprise,” a term used to describe a stunning development that could reshape election prospects, that could come in the form of a rushed COVID-19 shot. Professors Ezekiel Emanuel and Paul Offit wrote a New York Times op-ed outlining an “incredibly dangerous scenario” that’s not “far-fetched” based on “how this president has behaved.” 

Under one scenario, the authors could see the White House pushing the FDA to authorize a vaccine with inadequate data for political gain just before the election, the authors wrote. The agency already authorized one drug—hydroxychloroquine—under pressure from the Trump administration, without the data to back up the decision, they pointed out. 

And on the drug-pricing front, Sen. Chuck Grassley said he plans to push for a vote on legislation to limit pharma price hikes, Bloomberg reports. Drug pricing was anticipated to be a hot election issue in 2020, but amid the COVID-19 pandemic and global racial justice protests, there has been minimal political action on the issue.

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