Food and Drug Administration chief Martin Makary and two of his top deputies plan to gather input from drugmaker CEOs via a nationwide “listening tour” they’ll conduct over the next several months.
Their goal, according to a brief Tuesday statement, is to collect information on how the agency can modernize its regulations to “better support innovation and patient access to safe and effective therapies.”
The first forum will be held June 5 at FDA headquarters in White Oak, Maryland. Subsequent discussions are planned in San Francisco, San Diego, Boston, New York and Atlanta.
“These CEO Forums are a chance for the FDA to listen and gather feedback from those at the front lines of discovery,” Makary said in the statement. Joining Makary will be Vinay Prasad, the newly appointed head of the FDA office that oversees vaccines, blood products and most cell and gene therapies, as well as Principal Deputy Commissioner Sara Brenner.
The FDA asks interested companies to register via brief form, which specifies that participating drugmakers must have at least on application for either a clinical trial or a new drug approval on file with the agency. The sessions will be closed to press, the FDA said.
Makary, like his boss Robert F. Kennedy Jr. at the Department of Health and Human Services, has pledged greater transparency. So far, however, that’s taken more unconventional and direct forms, such as a series of informal conversations the FDA has posted to YouTube, or policy pronouncements via the social media platform X.
It’s not clear how these discussions will inform FDA policy, or whether the agency will share its perspective on the input it gathers.
The tour is also notable for who will participate from the agency: longtime agency leaders like Richard Pazdur, who heads the Oncology Center of Excellence, aren’t listed as involved, nor is anyone from the Centers for Drug Evaluation and Research, which reviews most drugs. (CDER is currently run by acting director Jacqueline Corrigan-Curay.)