FDA Nominee Challenges Biden’s Vaccine Authorization Process During Confirmation Hearing

WASHINGTON, D.C. — Dr. Marty Makary, nominated to lead the Food and Drug Administration (FDA), faced scrutiny during his confirmation hearing on Thursday, particularly regarding the Biden administration’s decision to forgo critical committee meetings in the vaccine authorization process. The hearing took place as Senators questioned Makary about various public health topics, specifically vaccines and advisory committee procedures.

During the Senate Committee on Health, Education, Labor and Pensions (HELP) session, Sen. Patty Murray, D-Wash., pressed Makary on the FDA’s lack of a Vaccine Advisory Committee meeting for a COVID-19 booster authorization, which had been canceled at the last minute. “So if you are confirmed, will you commit to immediately reschedule that FDA Vaccine Advisory Committee meeting to get the expert views?” she asked.

In his response, Makary pointed out the Biden administration’s choice to skip essential committee discussions. “Well, you can ask the Biden administration that chose not to convene the committee meeting for the COVID vaccine booster,” he noted, asserting that he was not involved in that decision.

The FDA’s actions in 2021 were highlighted, as they went ahead with the approval of a COVID-19 booster for individuals over 18 without calling for an Advisory Committee meeting, a departure from past protocols. In a previous statement, the FDA explained that it deemed the requests from Pfizer and Moderna did not warrant further expert discussion.

One member of the committee, Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, expressed concern at the time, stating, “We’re being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value.”

Following the hearing, reporters asked Sen. Murray if she shared concerns over the Biden administration’s lack of advisory committee engagement. She expressed a loss of confidence in public health agencies’ adherence to science and expert advice. “In 2022, I had confidence that our public health agencies were following the latest science and listening to public health experts. I do not have that confidence now,” Murray said.

Murray also criticized the recent cancellation of the annual influenza advisory meeting, which she noted had taken place for over 30 years. “There has been zero justification for its cancellation or any information about when it would be rescheduled,” she argued. “The flu vaccine is safe, effective, and lifesaving—we need this advisory committee to meet so manufacturers have enough time to prepare the correct vaccines.”

Leading up to the hearing, Murray and fellow Democratic Senators Tammy Baldwin of Wisconsin and Angela Alsobrooks of Maryland sent a letter to Makary, emphasizing their intent to use the session to gauge his support of returning to a more timely public health decision-making process.

HELP Committee Chairman Bill Cassidy, R-La., also questioned Makary about maintaining objectivity and transparency in advisory committees. “How will you ensure that advisory committees remain objective, transparent and still benefiting from the necessary expertise of external experts?” Cassidy asked.

In conclusion, Makary responded affirmatively, assuring the committee, “You have my commitment to review what the committees are doing [and] how they’re being used.” He added that he had been critical of the FDA’s lack of committee engagement during previous COVID booster discussions, reiterating concerns that FDA leadership had previously claimed that committee convening was optional.