August 26 2020
Critics are slamming the FDA and Commissioner Stephen Hahn for authorizing COVID-19 plasma treatment prematurely, but the issue is much broader than one emergency use authorization. The agency's reputation is on the line. And if it falls, the pharma industry will pay a hefty price.
Since Hahn stood beside President Trump Sunday to announce the plasma authorization, critics of all kinds have lit up social media—commenting that they can’t trust the FDA, or won’t take drugs it approves or, perhaps most notably, won’t get a COVID-19 vaccine even if stamped with the agency's approval.
And there's some basis for the concerns that FDA decisionmaking has been politicized. Recently, the White House strategized about pushing AstraZeneca's vaccine to market before the election, ahead of full data from its 30,000-patient late-stage trial, according to reports. President Trump himself has repeatedly promised to have a vaccine by October. Indeed, in a controversial tweet that helped spark the plasma controversy, the president accused the agency of being part of a "deep state" effort to slow-walk vaccines until the election.
While AstraZeneca refuted reports of a fast track for its shot, telling FiercePharma it has not discussed any emergency authorization with the U.S. government, the constant swirl of rumors around vaccine approval, along with the FDA's most recent actions, have experts worried about the effects on the agency's independence and public confidence in its decisions, particularly during the pandemic.
“FDA's credibility has never been more important and more threatened simultaneously,” said Mark Senak, a public relations professional and Eye on FDA blogger, especially as phase 3 data on COVID-19 drugs and vaccines begin to come in and the need for public trust increases.
Senak has written about the problem of a politicized FDA since December, saying Monday that “if there were concerns then, it is only compounded now in the midst of a pandemic.”
Some press releases from the FDA, for instance, have made the FDA sound like cheerleaders for the Trump administration, Senak said, including the plasma release which is absolutely “cheerleader language.” The ti...
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