HHS Says Memo Won’t Take Power From the FDA

HHS on Sunday refuted reports that a new departmental memo will take decision-making power away from the FDA regarding the approval of COVID-19 vaccines or therapeutics.

The Sept. 15 memo, signed by HHS Secretary Alex Azar, gives him the authority to sign new rules on regulating drugs, medical devices and other products — barring the FDA from doing so. It comes as the Trump administration pushes to get a COVID-19 vaccine approved before year’s end, which has raised concerns about political pressure on the agency.

HHS commented on the memo on Twitter, saying it was a “good governance, housekeeping action” that will not slow down the FDA’s work. HHS also said the memo was issued “to ensure consistency with congressional intent. It has nothing to do with COVID-19, guidances, vaccine authorization or therapeutics.”

But the memo was met with criticism from former FDA officials. It’s “more of a problem than most people realize on the surface,” former FDA Commissioner Robert Califf wrote on Twitter.

And Scott Gottlieb, another former FDA chief, said in a televised interview Sunday that the memo was “the wrong move at the wrong time,” and suggested that the “independence of the agency is being eroded or influenced.”

At least three late-stage vaccine trials are under way, and accusations that the FDA will bow to political pressure to approve a vaccine before the presidential election continue to swirl. FDA Commissioner Stephen Hahn has said the agency is prepared to issue an Emergency Use Authorization before phase 3 trials are complete if the benefits outweigh the risks (DID, Sept. 1). But President Trump, who has repeatedly said a vaccine could arrive as early as next month, has accused agency officials of being politically biased and intentionally delaying decisions on a vaccine.

Eight senior FDA executives wrote in an op-ed earlier this month that the agency’s decisions are solely based on scientific evidence while acknowledging that the FDA “operates in a political environment.”  (DID, Sept. 11). And Hahn also has publicly asserted that he would resign rather than base a vaccine decision on anything other than science.

Most recently, Hahn said that he would not override agency officials’ decisions on any vaccine even though he has the legal authority to do so. — Jordan Williams