Reflecting On Continued Turbulence At The FDA
By Tyler Menichiello, Chief Editor, Bioprocess Online
By now, everyone’s heard of former FDA commissioner Marty Makary’s coerced resignation from the agency and the FDA’s top food regulator, Kyle Diamantas, stepping in as acting commissioner. It is still unclear who will permanently take over as commissioner, but according to CNN, administration officials are hoping to suggest a replacement by early June.
“Even before Makary’s resignation, many in the pharmaceutical industry were questioning whether FDA still offered the level of regulatory predictability that companies had long relied on,” writes John W.M. Claud, an attorney and partner at Nelson Mullins Riley & Scarborough, in his recent guest column about the FDA’s pilot of one-day inspectional assessments.
Surely Makary’s departure isn’t helping to quell these concerns.
As one of Bioprocess Online’s Editorial Advisory Board members wrote in response to my questions on the matter, “This is just the latest thing that erodes the public trust and undermines our position as global leaders on regulatory issues.”
Other board members expressed similar concern.
“This just perpetrates the instability of a very critical part of our industry and regulatory apparatus during a time of great advances in therapies for the U.S. and the world,” says Herman Bozenhardt, a trusted member of my advisory board.
“FDA stability matters for companies developing biopharmaceuticals,” said another one of my advisory board’s resident consultants. “That’s particularly true for smaller companies that have a limited runway, where delays or disruption can have a real impact on both development timelines and financing.”
According to Bozenhardt, this most recent shake-up at the agency will cause disruptions, confusing mixed signals, and reduced compliance in the industry. It may also result in a division of resources that can affect small- to mid-size biotechs currently navigating BLA submissions and facility approvals.
“The agency, like the NIH and CDC, will feel new pressures,” says Bozenhardt. “We need a strong, stable level of competence and the ability to attract new talent into these organizations. Clearly, when leadership changes priorities, training and recruitment always take time to sort out.”
In the meantime, all the industry can hope for is a successor who understands the technology and data driving the next generation of biopharmaceutical development and who will support that innovation, while also prioritizing patient safety and regulatory predictability. “Anything less, and we are not providing the best focus for our industry,” says Bozenhardt.
In short, the industry needs a commissioner who can match Makary’s ambitions towards efficiency without losing sight of the framework that established the U.S. as a leader in biomedical innovation in the first place. Above all, the industry needs someone who will bring regulatory stability to the turbulent environment we’ve been stuck in for the past year.
Whether this administration will deliver on that necessity remains to be seen.