1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

Senators Scrutinize US FDA Commissioner Nominee Makary Over VRBPAC Cancellation

 
• By Sue Sutter

Martin Makary said he would re-evaluate the topics that deserve a Vaccines and Related Biological Products Advisory Committee review, but did not commit to rescheduling the cancelled meeting on influenza vaccine strain selection.

Martin Makary Senate Confirmation Hearing
FDA Commissioner nominee Martin Makary faced questions about a cancelled vaccines advisory committee meeting during his confirmation hearing. (Screenshot of Senate Broadcast)
Key Takeaways
  • FDA decisions on influenza vaccine strain selection are largely a rubber-stamp of international recommendations and may not warrant a VRBPAC review, commissioner nominee Martin Makary said during his confirmation hearing.
  • However, he suggested some other vaccine-related issues, such as use of COVID-19 boosters, may warrant more advisory committee attention.
  • Makary has no “preconceived plans” to reconstitute committees but suggested a need for greater scrutiny of conflicts of interest.

US Food and Drug Administration Commissioner nominee Martin Makary told a Senate committee he will re-examine the topics that should go before the agency’s vaccines advisory committee.

However, Makary did not commit to rescheduling the Vaccines and Related Biological Products Advisory Committee’s recently cancelled meeting on influenza strain selection for the 2025-2026 vaccine.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

More from Vaccines

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

US FDA Vaccine Framework Coming In Weeks, But Details Vague

 
• By Sarah Karlin-Smith

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.