Just one too much controversies, just too many career FDAers’ decisions overridden, just too much change to vaccine recommendations, and, apparently, just one too many changes in previously agreed-upon requirements have led to the second departure of Vinay Prasad from the position of Director, Center for Biologics Evaluation and Research. Commissioner Makary announced that Prasad will be leaving the FDA at the end of April.

A string of decisions sealed Prasad’s fate. The latest, and likely the last straw, was the tiff with uniQure on its gene therapy. But other missteps, like changing the childhood vaccine schedule, the initial refusal to accept Moderna’s mRNA flu vaccine, and the flip-flop on Sarepta’s Duchenne muscular dystrophy gene therapy, likely played into the final decision for his departure.

Who will take his place? We don’t know yet but (hopefully) a career FDA scientist might be a good choice to right the ship. Taking politics out of scientific decision-making is likely the right way to begin to restore faith in the Agency. The FDA was once one of the most trusted governmental institutions. Now, not so much. A query of AI on how the public views the FDA yielded the following responses:

  • Recent surveys indicate a drop in public trust in the FDA’s effectiveness.
  • Concerns about food safety and drug approvals have contributed to negative views.
  • High-profile controversies, such as vaccine approvals, have influenced public opinion.
  • Increased scrutiny from media and advocacy groups has highlighted perceived shortcomings.
  • Comparisons with other health organizations show a relative decline in confidence.
  • Ongoing debates about regulatory transparency continue to affect public perception.

Having spent a good deal of my life in the FDA and in FDA-regulated industry, it pains me to see these decisions (that were made not based solely on solid scientific principles and data) lead to some of the changes we’re seeing at the FDA as well as other Federal health agencies. One can only hope that the damage to the FDA’s reputation can be repaired and that faith in the Agency can be restored.