Peacetime at the FDA

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With the Delta variant continuing to surge, President Joe Biden claims, “We are still on a wartime footing, and every American who is eligible should take immediate steps to get vaccinated right away.”

But his Food and Drug Administration is already back in peacetime, dragging its feet on giving final OK to the vaccines that have gone into 165 million American arms. More, it has stopped giving new emergency approvals for anti-COVID treatments and technology, and is even rescinding some it made over the last year and a half.

Biden needs to take a page from his predecessor and kick the agency out of its normal plodding pace.

Yet he doesn’t seem to have a clue: Seven months in office amid the pandemic, he hasn’t even nominated a permanent FDA head. That’s pretty “peacetime.”

A day after his “wartime footing” brag, Biden told reporters, “God willing, the FDA is going to be coming out in a reasonable time frame to say this vaccine is totally safe.
God willing? It’s your will that’s lacking here, sir.

Biden’s top medical adviser, Anthony Fauci, says the absence of permanent approval is just a “technicality” and Americans should act as if it’s real.

Should, sure, but such talk won’t persuade the vax-hesitant. Three in 10 unvaccinated adults say they’d be more likely to get jabbed if a vaccine got full approval, the Kaiser Family Foundation found. That rises to half in the “wait and see” unvaxxed group.

It’s the No. 1 thing that would move vax hesitancy — even $100 payments only move the needle for 15 percent, Kaiser determined.

Yet all signs are that the FDA won’t give full approval to Pfizer’s jab (the first of three to get emergency-use OK last year) before September.

Heck, it seems to be actively stalling: “They required two extra months of safety data after the clinical trial was done, which is not really normal either,” notes University of South Florida Health virologist Michael Teng.

And FDA leaders have delegated the approval — as per “peacetime” practice — to the Center for Biologics Evaluation and Research Office for Vaccines Research and Review, the Office of Biostatistics and the Office of Compliance. How many levels of bureaucracy do we need “on a wartime footing”?

Meanwhile, White House officials say Biden may take weeks to even pick a successor to Janet Woodcock, the acting commissioner. The prez said recently, “We’re working on that very hard to make sure we can get it passed,” implying his team can’t find a nominee it thinks will get Senate confirmation. It should be easy enough, if you pick someone nonpolitical.

Yes, the FDA gave emergency-use authorization to monoclonal antibody treatment REGEN-COV last month, but that’s an exception. Meanwhile, it rescinded the OK for investigational monoclonal antibody therapy bamlanivimab, when administered alone, in April and last month barred providers from using unapproved respirators or reusing disinfected respirators, deciding the supply of N95 masks was enough.

“It’s very similar to a recall,” Marcus Schabacker of health-care safety group ECRI told Modern Healthcare, noting that providers constantly need to track what  the FDA still allows.

It’s lunacy to handcuff frontline health professionals working to stave off the surge and madness to simply pray for FDA action on the jabs.

Biden is in charge of the FDA. He should start acting like it.

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