Trump FDA Chief Reportedly Makes End Run Around Career Bureaucrats

Food and Drug Administration (FDA) Commissioner Marty Makary and his new vaccines chief reportedly boxed longtime bureaucrats out of the recent decision to require more data to support COVID-19 booster shots, the Wall Street Journal reported Tuesday.

Makary and Center for Biologics Evaluation and Research Director Vinay Prasad unveiled a new framework in the New England Journal of Medicine on May 20 requiring a stronger evidence base for boosters in healthy adults and children — a departure from what they described as the Biden administration’s “repeat-boosters-in-perpetuity strategy.”

This framework was unveiled without input or interference from FDA career staffers, according to the WSJ.

The top FDA officials outlined their expectations to vaccine manufacturers, stating that they do not expect to approve new COVID-19 boosters for use in adults and children with no preexisting conditions without new clinical trials. Many high-income countries like the United Kingdom and Australia do not recommend booster shots for these populations.

Some FDA bureaucrats are looking to exit into the pharmaceutical industry under the new leadership, the WSJ reported. Many drug reviewers have opted to recuse themselves in recent months, a signal they are meeting with drugmakers about new jobs. Makary meanwhile is seeking to shore up morale, frequently lauding staffers on a new FDA podcast