WASHINGTON — FDA Commissioner Robert Califf appeared before the House Oversight Committee on Thursday to plead his case again for more authority to monitor the supply chain to prevent drug shortages.
Califf fielded a wide array of questions on issues ranging from lead in some applesauce pouches to Covid-19 vaccines to abortion drugs. But members of both sides of the aisle touched on drug shortages, which could see new legislative action as congressional hearings late last year pledged to help.
Oversight Committee Chair James Comer (R-KY) pressed Califf on FDA’s response to drug shortages, saying that the agency hasn’t done enough to support domestic manufacturing.
“The FDA must improve coordination with manufacturers and federal agencies, including DEA, DOJ and DOD to increase production,” Comer said. “And FDA failed to incentivize domestic manufacturing and pharmaceuticals, resulting in significant offshoring of these facilities.”
Meanwhile, Democratic members of the committee said that the FDA needs more authority to collect data from manufacturers about potential drug shortages.
“Public attacks on FDA, without any corresponding legislative solution, simply undermines the ability to effectively protect public health,” ranking member Jamie Raskin (D-MD) said.
Califf emphasized that there are different driving forces of drug shortages, with shortages of less expensive generic drugs being reflective of supply chain issues.
“The biggest shortages are occurring in inexpensive generic drugs where the less expensive the drug, the more likelihood of shortage because of the way the market is not succeeding in rewarding high-quality manufacturing. And that’s the point I think we really need to address over the next few years,” he said.
In his written remarks, Califf also pointed to several other solutions around transparency, calling for
enhancing FDA’s insight into the drug supply chain to more effectively identify risk of a shortage, closing a loophole that does not require manufacturers to notify FDA if a likely shortage is caused by a spike in demand, understanding supplier reliance, evaluating facilities that plan to produce and import products that do not require an application, and requiring manufacturing facilities to submit Site Master Files containing information about their quality management policies, controls, and activities.
The hearing also offered a snapshot of the political forces facing the FDA as this fall’s presidential election nears.
Raskin also highlighted the FDA’s work around reproductive health, including approving the first over-the-counter birth control this past fall, and its regulations around access to the abortion pill mifepristone.
Califf responded to false accusations from Rep. Paul Gosar (R-AZ) that the agency was wrong with Covid-19 vaccines, ivermectin and other pandemic-related issues, saying that the FDA made a mistake in granting emergency use authorization to the first Covid-19 vaccines.
“I’ll remind you again,” Califf told Gosar. “We always have to do studies or clinical trials to figure out the risks and benefits … I personally participate in clinical trials when I have the chance.”
