In confirmation hearing, FDA nominee Martin Makary talks drug reviews, vaccines, ethics and more
Hearing Overview
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Dr. Martin Makary appeared before the Senate Health, Education, Labor and Pensions Committee on March 6, 2025 for his confirmation hearing to become FDA Commissioner12.
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He faced questions on a range of topics including drug approvals, vaccine advisory meetings, ethics policies, and recent staffing changes at the FDA23.
Key Topics Discussed
Drug Review Process
- Makary committed to ensuring drug reviews are conducted "properly" and "expeditiously"2.
- He expressed support for accelerated approvals and customized regulatory pathways for rare diseases3.
- Makary said he wants to streamline approvals for generics and biosimilars2.
Vaccine Advisory Committee
- Senators pressed Makary on the recent cancellation of a key vaccine advisory committee meeting12.
- Makary did not commit to rescheduling the canceled meeting, but said the committee "will be meeting" if he is confirmed24.
- He said he would "reevaluate which topics deserve a convening" of the advisory committee4.
Ethics and Conflicts of Interest
- Makary pledged to review ethics policies for FDA advisory committees2.
- He emphasized keeping the scientific review process "free of any conflicts"2.
FDA Staffing
- Makary committed to assessing current FDA staffing levels if confirmed12.
- He distanced himself from recent layoffs, saying he was not involved in those decisions3.
Other Topics
- Makary discussed potentially transitioning more prescription drugs to over-the-counter status1.
- He expressed interest in using artificial intelligence to improve FDA operations1.
- Makary said he would reassess the system for approving food additives and chemicals1.
Overall, Makary aimed to present himself as focused on science, efficiency, and transparency while avoiding firm commitments on controversial topics. Analysts viewed his positions as generally positive for the pharmaceutical industry, particularly in areas like rare disease drug development3.
Sources:
1. https://www.hklaw.com/en/insights/publications/2025/03/nih-and-fda-nominees-go-before-the-help-committee
2. https://www.fiercepharma.com/pharma/fda-commissioner-nominee-martin-makary-pressed-cancelled-vaccine-advisory-meetings-senate
3. https://www.biospace.com/policy/makary-shows-soft-support-for-fda-vaccines-committee-at-confirmation-hearing