Key Takeaways:
- Direct Access: FDA Commissioner Marty Makary is leading nationwide CEO Forums to hear directly from biotech and pharma leaders on modernizing the regulatory framework.
- Innovation Focus: The initiative aims to cut red tape, accelerate life-saving therapies, and improve patient access without compromising safety or scientific integrity.
- High-Level Dialogue: Forums will be held in major innovation hubs through September, with attendance limited to top executives from companies actively filing with the FDA.
The Food and Drug Administration is hitting the road—and for once, it’s not to pile on more regulation. FDA Commissioner Marty A. Makary, M.D., M.P.H., along with top agency leaders Vinay Prasad, M.D., M.P.H., and George Tidmarsh, M.D., Ph.D., have launched a nationwide “CEO Forum” listening tour to hear directly from biotech and pharmaceutical executives about how Washington can get out of the way and help innovation thrive.
“These CEO Forums are a chance for the FDA to listen and gather feedback from those at the front lines of discovery,” said Makary. “We are committed to strengthening a regulatory environment that enables breakthroughs to reach patients faster, while upholding the highest standards of safety and scientific integrity.”
The forums will be held in major innovation hubs including Boston, San Francisco, New York, and Raleigh through September. The invite list isn’t open to just anyone: eligible companies must have at least one active IND, NDA, or BLA on file with the FDA, and attendance is preferred at the CEO level.
It’s a refreshing sign of accountability for an agency that has long been criticized for bureaucratic bottlenecks slowing life-saving therapies. By cutting through red tape and listening to leaders who actually bring products to market, the FDA is signaling it wants to modernize its approach.
If done right, these forums could lead to faster cures, better patient access, and a regulatory framework that rewards—not punishes—American ingenuity.