Amid ongoing drug shortages and other headline-grabbing issues that fall under the FDA’s purview, the House Committee on Oversight and Accountability is putting the agency’s commissioner Robert Califf, M.D., on the hot seat.
In what could be a heated culmination of multiple concurrent House investigations, the committee is set to press Califf in an April 11 public hearing that will seek to “hold the commissioner accountable for what the FDA is doing to address ongoing crises,” committee Chairman James Comer, R-Kentucky, said in a press release.
Outside of the drug shortage probe, the hearing is set to explore the FDA’s response to the nationwide infant formula crisis, its regulation of tobacco and nicotine products as well as hemp and CBD-derived products, plus efficacy concerns surrounding certain over-the-counter decongestants.
Through several investigations, the oversight committee has “identified how dysfunction at the FDA could be worsening many of these preventable crises,” Comer noted in the statement.
Califf will face questions about what the agency is doing to address the issues and how it’s conducting plant inspections to prevent similar supply shortfalls going forward.
The hearing follows a series of governmental efforts to lock down answers from the FDA about the ever-present flow of drug supply issues.
In November, Comer and Lisa McClain, R-Michigan, chairwoman of the Subcommittee on Health Care and Financial Services, together inked a letter to Califf concerning drug shortages and the agency’s mitigation strategies.
The lawmakers requested documents and a staff-level briefing on the matter, citing the 128 drugs that the FDA listed as facing active shortages at the time. Some of the key reasons for the supply chain issues that were flagged in the letter included an “over-reliance” on foreign manufacturing, coupled with “surging demand” and “diminishing” production of generic medicines.
And in August, 11 Republican governors sent a letter to Congress demanding action on the shortages such as new policy solutions to beef up supply. The governors also called for more transparency both in the manufacturing chain and from the FDA itself about instances that can lead to supply chain disruptions.
At the time of the letter, Califf had just recently outlined a “fundamental problem” with the current state of manufacturing. As it stands, low prices for generics can drive manufacturers out of the market, he said in a presentation of the Alliance for a Stronger FDA.