FDA’s Covid Plasma Treatment EUA Provokes Backlash

26.08.2020 - On the day after president Donald Trump’s announcement that the Food and Drug Administration (FDA) had granted his request for an Emergency Application (EUA) to treat Covid-19 patients with blood plasma drawn from convalescents, the US pharma and biotech communities as well as the social media universe were heatedly debating its implications.

Lawmakers were concerned as to whether the recent plethora of EUAs, like the president’s many executive orders, were entirely legal, while some drugmakers worried about the industry’s reputations amid a spate of politically touted treatments outside the realm of approved products.

FDA commissioner Stephen Hahn had to eat crow after a misstating a figure that was later tweeted by Trump, and even the previous FDA  commissioner, Scott Gottlieb weighed in with, albeit, mild criticism. The golden thread running through it all was the question of whether the FDA is becoming politicized and what damage this may have been done to its scientific reputation.

From the sidelines, UK drugmaker AstraZeneca also waded into the fray after leaders of the House of Representatives committee on Energy and Commerce wrote to Hahn, saying they were also “gravely concerned” about the president’s recent statements accusing the FDA of delaying a vaccine for Covid-19 until after the November elections – as well  Hahn’s lack of response to it. 

AstraZeneca stressed that it could and would not make a deal with the US government to supply a Covid-19 vaccine under an EUA before the completion of its ongoing Phase 3 trial with 30,000 patients. Earlier, Trump had speculated that the drugmaker might be willing to help him fulfil a promise to have a vaccine ready for use by October.

Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), who was called on to comment on the decision to issue the EUA for blood plasma infusions, told the Reuters news agency he was not under political pressure to speed a vaccine to market but that he would quit if that changed.

In their letter, the lawmakers suggested that the FDA had made concessions to the political sector by granting – though later retracting – an emergency authorization for hydroxychloroquine as a Covid-19 treatment. They also slammed the administration’s criticism of Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases and White House coronavirus task force member, along with the president’s sidelining of the disease experts at the Centers for Disease Control and Prevention (CDC).

With a deadline of Sept. 4, the committee has asked Hahn to provide information about the FDA’s safeguards to defend itself against political pressure and requested detailed information about future vaccine reviews.

“The issue is much broader than an emergency use authorization,” pharma industry journal Fierce Pharma wrote in an editorial. “The agency's reputation is on the line. And if it falls, It will pay a hefty price,” the editors commented

Many commentators from within the pharma and science worlds have taken to social media to question Hahn’s perceived coziness with the White House. Some lay critics have commented said they no longer trust the FDA, might not take drugs it approves or line up for a Covid-19 vaccine greenlit by the agency, for fear it had not been adequately tested, a stance that not that long ago would have startled.

A blogger on drug regulatory issues took aim at the health agency for its “pandering” press release on the EUA. The release with the title “FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic” was written in “cheerleader language, said Mark Senak.

Hahn came under the most pressure for his misstatement during the presidential press briefing that the Mayo Clinic’s plasma infusions had shown a 35% improvement in survival rates of Covid patients.  The FDA’s official communication instead said that patients under the age of 80 who received plasma containing high levels of antibodies had a 35% improved survival rate a month after treatment compared with those receiving plasma with a low level of antibodies.

 While the commissioner apologized for the communication error, he defended the decision to widen the authorization, saying the FDA’s decisions “have been and will continue to be based on good science and data.”


Author: Dede Williams, Freelance Journalist