U.S. Food and Drug Administration (FDA) commissioner nominee Stephen Hahn alluded to hiring challenges at the agency, saying the FDA must put “the right people in place” to modernize the federal drug approval process because “science is moving so quickly.”
Hahn made the comments at his U.S. Senate confirmation hearing on November 20.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, expressed concern in October the FDA is rapidly losing medical experts to the private sector.
“The ACs [advisory committees] just have so many rules and lawyers,” BioPharma Dive quoted Woodcock as saying. “It’s really difficult to get people with the greatest expertise.”
That wasn’t the first time Woodcock mentioned the obstacles the FDA’s bureaucracy poses to pharmaceutical innovation and access.
“It’s not working, and it won’t work in the future,” she stated at a “Breakthroughs in Medicine” conference in September. “We need the whole system to evolve and change if we’re going to do what we set out to do: help every patient feel better and live longer.”
The FDA is having trouble competing for a limited pool of talent, the administrators say.
“Sometimes, [the biopharmaceutical companies] are competing to actually pick people from our agency,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Review, at the Biopharma Congress in October. “That’s always fun.”
The staffing challenge is another reason for the FDA to modernize its approval process, says Ed Hudgins, research director at The Heartland Institute, which publishes Health Care News.
“The fact that the FDA has 15,000 employees but finds itself unequal to the task of expediting certification of medications to meet patient demands points to the fact that its regulatory system is woefully out of date,” said Hudgins.
The Case for Free to Choose
Recent technological breakthroughs have compounded the challenge.
“This is especially true because innovative approaches don’t fit nicely into the testing regime mandated almost half a century ago,” Hudgins said.
“The best and the brightest are attracted more to discovering and developing those treatments and cures rather than to sit in a government bureaucracy to review what they didn’t create,” said Hudgins.
If the FDA is to remain relevant, it must modernize its treatment certification process to foster the innovations of entrepreneurs and researchers in the private sector, instead of being an impediment, says Hudgins.
“The FDA can best speed innovation and allow the efficacy of experimental treatments to be determined by backing the creation of a Free to Choose Medicine (FTCM) track,” said Hudgins.
FTCM would allow drug sponsors to offer treatments deemed to be safe but still being tested for efficacy. Data from early use could be put into a Tradeoff Evaluation Drug Database, which would speed up the drug approval process and provide much more information for regulators and health care providers alike.
Madeline Peltzer ([email protected]) writes from Hil