Tuesday’s departure of two influential scientists responsible for the Food and Drug Administration’s Covid-19 vaccine actions has brought a glaring issue within the agency to a critical boiling point: the need for true leadership.
When four scientists and physicians at two of the most important United States agencies leave during the middle of a global pandemic with no ready transition plan or heirs apparent, there is clearly a need to look to the agencies’ leadership.
It’s safe to say that acting Commissioner Janet Woodcock, once considered the likely Biden nominee, is clearly not getting the top job after concerns that her mistakes helped fuel the opioid crisis and criticism over her handling of the controversial approval of a drug for Alzheimer’s disease. The FDA, one of the most important regulatory agencies in the country, if not the world, needs leadership in the form of a commissioner now.
Dr. Marion Gruber, director of the FDA's Office of Vaccines Research and Review, and her deputy, Dr. Philip Krause, announced Tuesday that they plan to retire by November according to a memo from Dr. Peter Marks, director of the agency's Center for Biologics Evaluation and Research. Gruber is a 32-year veteran of the FDA, respected around the world for her work on a number of vaccines, including those for Ebola, Zika and now Covid-19.
The announcement that she plans to retire comes on the heels of several weeks of confusing messaging from public health officials which might have fueled the pending departures. The White House announced that Covid-19 booster shots would start Sept. 20, ahead of approval of the idea by the FDA or discussion by the country’s Advisory Committee on Immunization Practices.
That move from the White House did not go unnoticed by FDA staff. Prominent public health officials have debated the need for boosters, prompting many administration officials to take to social media and airwaves to clarify the who/what/when of boosters. The result is a confused American public and world health officials who consider America’s encouragement of third shots (while so much of the world’s population hasn’t had a first shot) greedy and gluttonous.
The planned departure of Gruber and Krause has been acknowledged inside and outside the agency as a loss for the globe, and there’s a good amount of speculation that the White House jumping in front of the FDA was the final straw. That story is certainly plausible — but it is more likely that their decisions to leave reflect a growing tension between career officials who have been pushed to the brink and felt at times irrelevant or unsupported.
The FDA lacks the necessary leadership in the Office of the Commissioner, and the public will pay a price for it.
As acting commissioner, Woodcock at first gave the agency reason to be hopeful, especially after the erosion of trust and suspected political influence over the commissioner’s office under former President Donald Trump. Finally, we saw someone who respected and understood the bench of strength within the country’s most powerful regulatory body! But Woodcock’s hands-off management approach has resulted in center directors wielding disproportionate influence. (Gruber and Krause both report to Marks, who reports to Woodcock).
Unexpected departures of credible nonpolitical staff have exacerbated tensions within crucial government agencies; the departures of Nancy Messonnier and Anne Schuchat at the Centers for Disease Control and Prevention came shortly after leadership changes prompted by Dr. Rochelle Walensky, Biden’s CDC director. Such departures are not unusual when they occur over months or years in the normal pitter-patter of government. But when four scientists and physicians at two of the most important United States agencies leave during the middle of a pandemic with no ready transition plan or heirs apparent, there is clearly a need to look to the agencies’ leadership. In this case, the FDA lacks the necessary leadership in the Office of the Commissioner, and the public will pay a price for it.
In the coming days, here is just a sampling of what the FDA’s Office of Vaccines needs to do:
- Review booster shot application from Pfizer/BioNTech
- Receive and review booster shot application from Moderna.
- Receive and review full approval application from Johnson and Johnson.
- Receive and review possible application for a mix-and-match strategy for Johnson and Johnson vaccines.
- Receive and review potential pediatric vaccine applications from all three manufacturers.
- Receive and review applications from additional vaccine manufacturers that are in queue to deliver on more vaccines for our country (Novavax, etc).
The sense of urgency is palpable, and it’s possible that the pressure of the pandemic took a toll on Gruber and Krause. But it is likely that the retirements of dedicated government servants could have been prevented — or at a minimum, deferred — had better leadership been in place.
