Pharma CEOs Urge Next FDA Commissioner to Restore Stability Amid Industry Turmoil

The CEO of the leading pharmaceutical trade group has urged the next Food and Drug Administration (FDA) commissioner to restore stability and certainty for drug developers. Speaking at Axios' Future of Health Summit, PhRMA CEO Steve Ubl emphasized the need for a predictable regulatory environment to support long-term drug development.

"What we really need from the next leader of the FDA is to calm the waters and reestablish that certainty and predictability," Ubl stated.

Bristol Myers Squibb CEO Chris Boerner echoed this sentiment, highlighting the lengthy and costly process of bringing new medicines to market. "Our time horizons are 10 to 15 years. We spend billions of dollars to bring one new medicine to market. And in that environment, we need to know that we've got a very stable FDA that sets consistent rules," Boerner said.

Ubl also noted that he was unfamiliar with the acting FDA commissioner, Kyle Diamantis.

FDA Faces Leadership Turmoil Ahead of Commissioner Resignation

The call for stability comes as the FDA has experienced significant upheaval in recent months. Commissioner Marty Makary resigned on Tuesday, following a period marked by staff layoffs and the departure of top leaders. The industry is seeking reassurance amid these changes to ensure uninterrupted progress in drug development.

Pharma Industry Pushes Back Against Proposed Drug Pricing Policy

The pharmaceutical sector is also resisting President Trump's proposal for Congress to enact a "most favored nation" drug pricing policy. This approach, currently implemented through voluntary agreements, ties U.S. drug prices to lower prices in other developed countries.

"We've been very clear with the administration that we have concerns about most favored nation as a policy," Boerner said. He warned that such policies could lead to "lower prices, but in every single instance they also generate rationing of care."

While the likelihood of congressional action is deemed low—due to Republican concerns over free market principles—the industry remains vigilant. David Marin, CEO of the pharmacy benefit manager group PCMA, has called on Congress to instead address what he describes as "pharma abuse of the patent system," which he argues inflates patient costs.