Drug industry leaders are calling urgently for the next FDA commissioner to restore order and predictability to the agency after a period of upheaval that saw the departure of longtime commissioner Marty Makary.
At a health policy conference this week, top pharmaceutical executives framed the moment as critical for the development of new medicines. Steve Ubl, CEO of the Pharmaceutical Research and Manufacturers of America, called for the incoming FDA leader to "calm the waters and reestablish that certainty and predictability."
The timing reflects real anxiety in the boardroom. Recent months have brought staff layoffs and the exit of senior FDA officials, creating what the industry views as a period of dangerous instability. Bristol Myers Squibb CEO Chris Boerner emphasized the stakes by walking through the economics of drug development. "Our time horizons are 10 to 15 years," he said. "We spend billions of dollars to bring one new medicine to market." In that environment, he argued, companies need "a very stable FDA that sets consistent rules."
Ubl acknowledged that Kyle Diamantas, the acting commissioner, is largely unknown to him and the industry, adding another layer of uncertainty to the transition.
The industry's plea for stability comes as it braces for a separate fight over drug pricing. President Trump has called on Congress to pass legislation adopting "most favored nation" pricing, a policy that would tie U.S. drug costs to lower prices paid in other developed countries. The approach has already been incorporated into voluntary agreements with some drugmakers.
Boerner pushed back hard on the concept. He said the administration's proposal would import foreign price controls that, while lowering costs, would inevitably result in "rationing of care." Pharma executives have made clear to the administration that they view the policy with deep concern.
The likelihood of Congress actually passing such legislation remains low, largely because Republicans worry about government interference in free markets. Still, the industry is taking no chances and maintaining active pressure against the proposal.
Not everyone shares pharma's view. David Marin, who leads the pharmacy benefit manager group PCMA, argued that Congress should focus instead on what he called "pharma abuse of the patent system" as the real culprit keeping prices elevated for patients.
Author James Rodriguez: "Pharma's framing of instability as the enemy works only if lawmakers buy that FDA chaos is worse than unchecked pricing power, and that's a tough sell right now."
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