FiercePharmaPolitics—FDA would consider COVID vaccines before phase 3 trials finish, commissioner says

September 1,2020

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.

With multiple COVID-19 vaccines racing ahead in late-stage testing, FDA Commissioner Stephen Hahn, M.D., said his agency doesn’t necessarily need those trials to wrap up before clearing them for use. 

In an interview with the Financial Times, Hahn said that the FDA would consider an approval application based on preliminary data from a phase 3 trial. The agency could issue an emergency use authorization or limit vaccine use to certain people, he told the newspaper. 

But the agency won’t buckle to political pressure, Hahn maintained. Such reviews and decisions could come right around the U.S. election, but the FDA will “stick to our core principles,” Hahn said. 

That commitment comes as most Americans believe politics, not science, is driving the FDA’s coronavirus vaccine review process, according to a new Stat and Harris Poll survey. Large majorities of Republicans and Democrats said they think science is taking a back seat to politics. 

Both developments follow a tough week for the FDA and its reputation. On Saturday, August 22, President Donald Trump on Twitter said there could be “deep state” members of the agency working to undermine the administration’s fight against the pandemic. Hahn later disputed the allegation in a Reuters interview. The tweet followed news that NIH chief Francis Collins and NIAID head Anthony Fauci had pressed the agency to delay authorizing convalescent plasma for COVID treatment, and media reports that some clinical trials were having trouble enrolling patients.

The next day, the FDA issued an emergency use authorization for convalescent plasma in hospitalized patients. The agency said controlled trials will be needed to prove the treatment is beneficial, but Hahn, Trump and HHS secretary Alex Azar held a news briefing to tout plasma as a breakthrough. Experts pushed back on the claims, and Hahn told FT he regrets “contributing to any misperception.” On Friday, the agency ousted its top spokeswoman after she had been in the role for just 11 days. 

Controversy at the FDA couldn't come at a worse time, said Mark Senak, a public relations professional and Eye on FDA blogger. He argued that the agency's credibility "has never been more important and more threatened simultaneously." But even amid the criticism, Hahn has tried to assure the public that FDA decisions will be based on science rather than politics, including a Washington Post op-ed.