Swallowing the FDA red pill
Earlier this month, the Biden administration bought 10 million courses of Pfizer’s new COVID-19 pill, Paxlovid.
Thanks to the Food and Drug Administration, however, it may be months before anyone can take it, as the agency hasn’t yet offered up a timetable for approving it. Its inaction will almost certainly result in scores of preventable deaths.
In clinical trials, Paxlovid proved nearly 90% effective at preventing hospitalization and death. The results were so promising, Pfizer ended its trial of the drug early. It would have been unethical to continue denying the antiviral pill to those in the placebo group. The decision to suspend the trial was made “in consultation with the FDA.”
Pfizer announced its promising trial results on Nov. 5. It submitted its application for emergency use authorization on Nov. 16. Since then, silence from the FDA. Until the agency gives a green light, it’s illegal to give the pill to patients.
Let’s pause to appreciate the absurdity. Depriving participants in the clinical trial of Paxlovid is considered unethical because it could save their lives. But depriving the thousands of people each day who are contracting COVID-19 of the drug is perfectly fine.
It’s just the latest instance of the government regulatory apparatus’s inability to respond to the pandemic. In early 2020, the federal authorities forbade academics, private companies, and independent labs from creating their own COVID-19 tests — despite the fact the test developed by the Centers for Disease Control and Prevention didn’t work.
They paused administration of Johnson & Johnson’s shot over misplaced worries about side effects and sowed hesitancy about the vaccines in the process. And they have failed to issue clear guidance on booster shots, to the point where state officials began ignoring them.
President Joe Biden’s nominee to lead the FDA, Dr. Robert Califf, will have his work cut out for him. He previously led the agency for 11 months at the end of the Obama administration. In his second stint as commissioner, he needs to make a speedy review of promising therapies a bigger priority.
Either that or Congress needs to step in and compel much-needed changes at the FDA.Read More