After investigations into the FDA’s response to severe drug shortages and other issues, the House Committee on Oversight and Accountability finally had its long-awaited chance to grill the agency’s commissioner Robert Califf, M.D., on a wide range of issues at a Thursday hearing.
Committee Chairman James Comer, R-Kentucky, kicked off the nearly five-hour event by criticizing the FDA for “failing to do the bare minimum” in ensuring food and drug safety and for “a pattern of issues” that show the agency “appears consistently unprepared for crises,” the representative said in his opening remarks.
One area the congressman singled out is FDA inspections, which he noted haven't yet returned to pre-pandemic levels overseas. Comer cited a previous investigation that found a 79% dip in foreign plant inspections in 2022 compared with 2019.
Later in the hearing, Califf agreed that “we need to pick up the pace” of inspections. To address some problems it was facing, the FDA recently “completely" reworked its inspection system in India, the FDA official said.
In January, meanwhile, the FDA laid out its plans to transition its Office of Regulatory Affairs to become a new Office of Inspections and Investigations, reassigning some 1,500 staffers to related roles.
The referee
Beyond inspections, Califf employed a metaphor early on in the hearing that he would go on to use several times.
“I think the best way to think about the FDA in general is that we’re referees,” he said.
That means that Congress “writes the rulebook” and drugmakers are “the players in the game.”
To better respond to drug shortages, the agency needs additions to the “rulebook” that would give it more visibility into the complex pharmaceutical supply chain, Califf explained.
As it stands, the FDA only has access to “spotty” information from manufacturers, especially considering that a large chunk of drug ingredients and generics come from foreign manufacturers. The FDA needs more consistent, digitalized data in order to quickly respond to shortages and come up with “predictive algorithms” that would allow the agency to preemptively intervene.
Califf referred to an April 2 white paper from the Department of Health and Human Services (HHS) that offered several solutions and explanations for the market forces at play in creating and exacerbating severe drug shortages.
The rulebook
Ranking committee member Jamie Raskin, D-Maryland, expressed his support for giving the FDA additional authority that would provide stronger supply notification requirements and other measures that would help mitigate shortages and otherwise “make our food and drugs safer,” he said in his opening remarks.
“It is crucial that the FDA continue to carry out its mission and create meaningful regulations based on sound science and not conspiracy theories or ideological programs,” Raskin added, referring to accusations that the FDA did not properly collect data on the risks of abortion medication mifepristone.
Califf, while happy to answer questions such as “is COVID-19 real?” was less inclined to discuss the efficacy and safety of mifepristone due to the ongoing Supreme Court review of the matter.
Elsewhere, the lawmakers pressed Califf on a range of areas including cannabis and nicotine regulation, frivolous drug patents, the recent spread of avian flu and even the FDA’s hybrid work model. Comer summed it up best by noting “we covered topics from seafood inspection, all the way to every other topic that I think could be imaginable.”
Still, the discussion often boiled down to a back-and-forth of various lawmakers asking Califf why the FDA is not more active in amending weak links in the supply chain, as well as its role in other topics of concern. In response, the commissioner often said the agency needs more authority.
Several Democratic representatives agreed with Califf, including Raskin, who told his colleagues that “if we want an effective strong regulator, we’ve got to give them the authority and the resources to get the job done.”