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 title? “FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic.”
Data from The Harris Poll, which has tracked public sentiment around the coronavirus since March, shows that among trusted resources for COVID-19 information, 78% of American say scientists are trustworthy, while only 49% say the same of the White House and president.
The danger for the FDA's reputation may be in getting too close to politics and politicians.
Harris Poll Managing Director Rob Jekielek said, "The closer you get to politics, the lower the numbers are; the closer you get to science, the higher the numbers are."
I am confident in the science part of the evaluation executed by CBER. The way the public part was handled will erode precious public confidence. You earn public confidence in small drops and you loose it in buckets.— Scott Gottlieb, MD (@ScottGottliebMD) August 24, 2020
On social media, prominent voices such as Obama administration health official Andy Slavitt weighed in, tweeting in part that Hahn “is wasting trust” in the FDA.
Former FDA commissioner David Kessler, who is now advising presidential nominee Joe Biden, said in a Politico interview, “It’s the job of the FDA commissioner, to make sure that the American people trust the agency. The other big job of the FDA commissioner is to put their body on the line in between all the forces that want to influence the agency.”
Public health experts and physicians were particularly dismayed about Hahn’s generic claim of plasma benefits, which was retweeted in video by the official FDA Twitter account, about a “35% improvement in survival.”
“This unfounded claim utterly scorches the reputation of the FDA at a critical time—what a complete embarrassment,” Adam Gaffney, a physician and instructor at Harvard Medical School Harvard, wrote in a tweet.
Another Canadian public health policy professor, Marc-André Gagnon, wrote “RIP: Reputation of @US_FDA” in his tweet refuting Hahn’s “willfull confusion” of the non-peer reviewed data.
Strike One: hydroxychloroquine EUA; Strike Two: convalescent plasma EUA; Strike Three: a vaccine before the election no matter if it works or not.— Gregg Gonsalves (@gregggonsalves) August 24, 2020
Hahn defended the decision in a series of tweets Monday night, although he conceded the criticism was "entirely justified." His mea culpa, however, didn't mollify all of science Twitter. His apology had more than 1,500 comments on Tuesday morning, many demanding a more public clarification or simply noting the damage was already done. The video of his inaccurate comments at the press conference remains posted on the official FDA Twitter handle.
Hahn did appear on "CBS This Morning" Tuesday maintaining the EUA decision was an independent one and conceding that he should have done a better job at the press conference.
The controversy comes as Hahn has, at least until now, firmly asserted the independence of the FDA to many sources amid the president's public push for a vaccine as soon as possible. He wrote an Op-Ed in the Washington Post a few weeks ago pointing out the administration's Operation Warp Speed is run by HHS and the Defense Department, and operates independently of the FDA.
He ended the column: "I have repeatedly said that all FDA decisions have been, and will continue to be, based solely on good science and data. The public can count on that commitment."