US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric (May 2025) CEO Forums: An FDA Listening Tour to Engage Pharma CEOs Article

[Michael Harrop]

• https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-makarys-pharma-ceo-tour-goes-against-transparency-rhetoric-3E5RP5IATVD73DRPQHZPSTHKRA/
• https://www.fda.gov/industry/ceo-forums-fda-listening-tour-engage-pharma-ceos

FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.

The meetings are closed to media and struck many as hypocritical given the professed goals of FDA Commissioner Makary and HHS Secretary Kennedy to eliminate corporate capture of the agency.

The meetings may be unusual, but experts thought they likely are legal, although limiting participants to those with active applications at the FDA drew the most concern.

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The U.S. Food and Drug Administration is conducting a national listening tour to meet directly with pharmaceutical and biotech CEOs. Held in major innovation hubs across the country, the CEO Forums will be led by FDA Commissioner Marty A. Makary, M.D., M.P.H., along with Principal Deputy Commissioner Sara Brenner, M.D., M.P.H and Director of FDA’s Center for Biologics Evaluation and Research, Vinay Prasad, M.D., M.P.H.

Registrants must have at least one active Investigational New Drug (IND), New Drug Application (NDA) or Biologics License Application (BLA) on file with the FDA.

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Related:
FDA Commissioner Marty Makary Announces Major New Policy to Limit Conflicts of Interest (Apr 2025) "we are removing industry members – pharma members – from FDA advisory committees"