Post-Prasad, FDA Must Embrace Reform

At long last, the Food and Drug Administration’s Center for Biologics Evaluation and Research Director Vinay Prasad is out. Prasad, who made the FDA drug approval process even more onerous and unpredictable than usual, will reportedly leave the agency in April. Prasad represents everything that is wrong with the FDA, which is rejecting even more drugs than usual despite President Donald Trump’s laudable deregulatory agenda. 

Post-Prasad, it’s up to FDA leader Marty Makary and Health and Human Services Secretary Robert F. Kennedy Jr. to streamline approvals and make the FDA’s risk aversion a thing of the past. Taxpayers and consumers deserve a fast and low-cost process that gets patients the medications they desperately need. 

The FDA’s problems certainly did not start with Prasad, and they won’t magically end when he is replaced. As the Independent Institute noted back in 2016, “When the side effects of a new drug cause little Tommy of 236 Elm Street, Saginaw, Michigan, to become gravely ill, television reporters show the poor lad languishing in a hospital bed.” But “[i]f little Tommy suffered from a disease that would be cured by a drug not yet allowed by the FDA, it is unlikely that Tommy’s parents or doctors would even be aware of that fact.” 

This asymmetry creates a powerful risk aversion at the FDA that has spanned across decades and presidential administrations.

However, patients and their families have been rightly outraged at FDA officials such as Prasad being even more reluctant than usual to approve game-changing health care products. 

Of Prasad’s many terrible decisions, one of the worst was the now-reversed refusal to even review Moderna’s mRNA flu vaccine. According to the refusal-to-file letter (strangely) signed directly by Prasad, the control (i.e., comparison product) used in Moderna’s application “does not reflect the best-available standard of care in the United States.” This bizarre assertion is completely contradicted by previous agency communications and comes across as a post hoc justification for limiting vaccine access. 

Moderna’s flu shot should have been a shoo-in for approval. In June, the company reported that, when compared to a currently licensed, standard-dose seasonal flu vaccine, mRNA-1010 was 26.6% more effective at preventing influenza in adults aged 50 years and older. Safety was certainly not an issue. “There were no significant differences between the [treatment and control] groups in the rates of unsolicited adverse events, serious adverse events, or adverse events of special interest.” 

Moderna wasn’t exactly reinventing the wheel with its study design. When the company first submitted its Phase 3 study protocol to CBER for review in April 2024, the FDA stated, “we agree it would be acceptable to use a licensed standard dose influenza vaccine as the comparator in your Phase 3 study.” While the FDA did recommend that Moderna “use a vaccine preferentially recommended for use in older adults by the ACIP (i.e., Fluzone HD, Fluad or Flublok) for participants >65 years of age in the study,” the agency made clear — in no uncertain terms — there would be no approval issues with going the standard route. 

After considerable public pressure, the FDA reversed course and agreed to review the application. But by then, significant damage had already been done. Drugmakers, and especially vaccine producers, now know that FDA review is no sure thing even if producers design their trials according to agency specifications and achieve encouraging results. 

Prasad might’ve been able to bounce back from that debacle, but he didn’t stop there. After yet another bizarre rejection — this time over uniQure’s experimental AMT-130 gene therapy for Huntington’s disease — a certain senior FDA official called the medication a “failed therapy” and discussed legally protected trade secrets with reporters to make his point.

Rep. Jake Auchincloss, D-Mass., outed the FDA official as Prasad and rightly noted that “Disclosing trade secret information without legal authorization is a prohibited act under the FDCA & a criminal violation under the Trade Secrets Act.”

Fortunately, Prasad now appears to be leaving for good. However, replacing the CBER director can only do so much to repair the frayed trust between the FDA and millions of patients and drugmakers.

To get beyond its current issues, the agency will need to change the way it does business and embrace innovation and the rule of law.

The current approach is most certainly not what the doctor ordered.