FDA Struggles to Retain Credibility

Dealing with the COVID-19 pandemic has been disastrous for FDA. A series of actions signaling premature support for unproven treatments promoted by the White House has undermined confidence in the agency’s decisions and independence. Now with hopes high for a safe and effective vaccine against COVID, industry and public health authorities seek to prevent political interference in approval decisions that can drive confusion and vaccine hesitancy across the nation.

Jill Wechsler

FDA stumbled early on in efforts to assess much-needed diagnostics when initial COVID lab tests authorized by the Centers for Disease Control and Prevention (CDC) proved inaccurate. Then the agency signaled support for treating ill patients with certain long-used malaria drugs —an approach loudly praised by President Trump and his advisors, but questioned by researchers and clinicians. FDA then had to rescind an emergency use authorization (EUA) for administering hydroxychloroquine to COVID patients when subsequent clinical studies found no clear benefit, and serious potential risks.

More damaging was a series of events in August related to emergency use of convalescent plasma to treat hospitalized patients. In a press conference, FDA Commissioner Stephen Hahn joined President Trump and Health and Human Services (HHS) secretary Alex Azar in a chorus of praise for this “major advance” in COVID care. Hahn’s support for the initiative was startling, as it came right after Trump lashed out in a highly public tweet about the “deep state” at FDA, implying that FDA officials were deliberately delaying product development until after the Nov. 3 election. Meanwhile, the White House continued to predict access to a COVID vaccine this month, which heightened fears that political pressure will lead to some kind of FDA authorization of a new vaccine before the Nov. 3 election, even if studies are incomplete.

CEOs mount defense

The situation prompted industry leaders to speak out publicly on the importance of rigorous clinical research and full study data for any authorization or approval of new COVID vaccines or treatments. Leaders of the Biotechnology Innovation Organization (BIO) issued a letter in August calling on FDA to maintain its “historic independence as the gold-standard international regulatory body” to assure the public that its decisions reflect the “highest standards of scientific and medical integrity.”

Five pharma CEOs similarly said they would not seek early authorization or approval of a new COVID treatment without a clear demonstration of product safety and efficacy from randomized clinical trials. During a virtual press conference organized by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Pfizer Chairman Albert Bouria stated that his company “will not cut corners” or take any action that would tarnish Pfizer’s scientific reputation. Eli Lilly will publish all data and “subject it to scientific scrutiny,” stated chairman David Ricks, also IFPMA president. Merck Chairman Kenneth Frazier and others urged reliance on FDA advisory committees to gain added transparency to approval decisions and guard against political influence.

And FDA’s senior leadership took the unusual step of publishing a strongly worded opinion piece asserting the integrity and independence of the agency in a move to fend off political interference in vaccine approval decisions. CBER Director Peter Marks, CDER Director Janet Woodcock, now on detail to the office of the commissioner, and six other top officials acknowledged that FDA operates in a political environment, but that if the agency loses credibility and trust, the public will doubt its recommendations and fear to use regulated products important to improving health and overcoming COVID-19. They ensured that regulatory decisions are based “on our unbiased evaluation of the scientific evidence.”

These statements aim to protect the integrity of the regulatory process from outside political interference as vaccine data moves through the pipeline. Manufacturers recognize that premature approval of any product would erode FDA’s coveted gold-standard reputation. Biopharma companies have much to gain from producing and distributing effective treatments able to slow or halt the lethal COVID pandemic, and even more to lose in reputation as well as financial health from allowing patient access to sub-potent or risky products. 

Jill Wechsler is Pharm Exec’s Washington Correspondent. She can be reached at jillwechsler7@gmail.com.