乌鸦传媒

Republican lawmakers tore into FDA Commissioner Robert Califf, MD, over the agency's handling of everything from the infant formula shortage crisis to the authorization of COVID-19 vaccines during a hearing of the House Committee on Oversight and Accountability on Thursday.

"Unfortunately, the FDA under President Biden is suffering from dysfunction and failing to do the bare minimum to carry out its core mission, which is to make certain our nation's food and drug products are safe and effective," said Committee Chair Rep. James Comer (R-Ky.) in his opening remarks.

COVID Vaccines, Ivermectin

During the hearing, Rep. Paul Gosar (R-Ariz.) said that "obviously the FDA made a mistake in granting the emergency use authorization and license of COVID-19 vaccines," which he noted do not stop transmission of the virus and have been linked to injuries and deaths reported to the Vaccine Adverse Event Reporting System.

"As head of the FDA, would you like to take an opportunity to express your regret in failing to curtail the chronic disease epidemic in America?" Gosar asked.

Califf explained that the initial COVID vaccine trials, upon which emergency use authorizations were based, showed a "dramatic reduction" in infection rates, but then the virus mutated.

And there is still evidence to demonstrate that "if , the mortality rate is lower," Califf said. "So, when you compare the two, yes, vaccines have side effects, [but] the risk of being dead is lower if you're vaccinated."

Gosar also criticized the FDA's "years-long smear campaign against ivermectin," but Califf said that randomized trials have found no benefit from ivermectin for treating COVID-19.

"What we're not doing is telling doctors what they have to do. Doctors have the right to prescribe ivermectin off-label," he added.

Infant Formula Shortage Response

Regarding the infant formula shortage crisis, Comer argued that the FDA had tried to use the COVID-19 pandemic as a cover for "neglecting facility inspections and justifying poor performance."

Rep. Lisa McClain (R-Mich.), who spearheaded an investigation into the shortages, asked Califf a series of questions regarding who at the agency and at the White House knew about the potential for a shortage and when.

Califf, who was confirmed to the post of FDA commissioner on Feb. 14, 2022, said he was aware that day that a manufacturer responsible for 40% of the nation's infant formula had voluntarily recalled products made at one of its plants, as it happened the day of his confirmation.

McClain argued that, based on internal emails that her committee obtained, FDA officials were discussing infant formula supply issues .

"Why did it take 3 months for President Biden to invoke the Defense Protection Act?" McClain asked, asserting that either the FDA didn't tell the president about the shortage or the president didn't act.

Califf said McClain had the emails and he could not comment further.

Committee Ranking Member Rep. Jamie Raskin (D-Md.) said Congress passed a bipartisan bill to respond to such shortages, but a second bill meant to strengthen FDA's oversight to help prevent shortages was rejected by over 200 Republicans.

Food Inspections

Raskin also lauded the agency's quick response to the finding of lead in applesauce packets, which were recalled in November 2023. The lead contamination was later found to be tied to a cinnamon processor in Ecuador.

Asked why the FDA can't inspect every private manufacturing facility, of which there are roughly 280,000, Califf likened the agency to a set of referees and industry to the player or "first line of defense." Congress "writes the rule book," he said.

While the FDA doesn't have the budget to inspect all private facilities, it can require the manufacturers to do the testing themselves, as is the case for drugs. With regard to the tainted applesauce, "if there had been mandatory testing when it got imported into the U.S. from Ecuador, the stores that were selling it probably would have picked it up at that point," Califf said.

Comment