Republican lawmakers criticized FDA Commissioner Robert Califf, MD, for the agency’s handling of everything from the infant formula shortage crisis to the authorization of COVID-19 vaccines, at a House Committee hearing on oversight and accountability on Thursday.
“Unfortunately, the FDA under President Biden is dysfunctional and does not do the bare minimum to carry out its number one mission, which is to ensure that our nation’s food and pharmaceutical products are effective,” said the committee’s chairman representative, James Comer. (R-Ky. ) in his opening remarks.
COVID Vaccines, Ivermectin
During the hearing, Rep. Paul Gosar (R-Ariz. ) said that “clearly, the FDA erred in granting emergency use authorization and license to COVID-19 vaccines,” which he said prevent transmission of the virus and have been linked to injury. and deaths reported to the Vaccine Adverse Event Reporting System.
“As head of the FDA, would you like to take this opportunity to clearly express your failure to curb the epidemic of chronic disease in the United States?” asked Gosar.
Califf explained that early COVID vaccine trials, on which emergency use authorizations were based, showed a “dramatic reduction” in infection rates, and then the virus mutated.
And there’s still evidence that “if you live in a county with a higher vaccination rate, the death rate goes down,” Califf said. “So when you compare the two, yes, vaccines have side effects, [but] the threat of dying is diminishing if you’re vaccinated. “
Gosar also criticized “the FDA’s years-long smear crusade against ivermectin,” but Califf said randomized trials have found no benefit of ivermectin in treating COVID-19.
“What we don’t do is tell doctors what to do. Doctors have the right to prescribe ivermectin off-label,” he added.
Responding to the Infant Formula Shortage
Regarding the infant formula shortage crisis, Comer argued that the FDA has attempted to use the COVID-19 pandemic to “neglect facility inspections and justify poor performance. “
Rep. Lisa McClain (R-Mich. ), who led an investigation into the shortage, asked Califf a series of questions about who in the company and in the White House was aware of the possibility of a shortage and when.
Califf, who filed as FDA commissioner on Feb. 14, 2022, said he knew that day that a manufacturer guilty of 40% of the nation’s infant formula had voluntarily recalled products made in one of its factories, as happened on the day of his confirmation.
McClain argued that, in internal emails received through his committee, FDA officials were discussing problems with the sources of infant formulas as early as Feb. 4 of that year.
“Why did it take President Biden 3 months to invoke the Defense Protection Act?” asked McClain, claiming that either the FDA informed the president of the shortage or the president acted.
Califf said McClain had the emails and could not comment further.
Rep. Jamie Raskin (D-Md. ), a member of the committee, said Congress passed a bipartisan bill to address such shortages, but a second bill for FDA oversight to help prevent shortages It was rejected by more than two hundred Republicans.
Food Inspections
Raskin also praised the agency’s quick reaction to the discovery of lead in applesauce packages, which were recalled in November 2023. He later discovered that lead contamination was linked to a cinnamon processor in Ecuador.
When asked why the FDA can’t control all of the personal production facilities, of which there are about 280,000, Califf likened the company to a set of referees and the industry to the player or “first line of defense. “Congress ‘writes the rules,'” he said.
While the FDA doesn’t have the budget to inspect all personal facilities, it can require brands to test themselves, as is the case with drugs. As for infected applesauce, “if there had been mandatory testing when it was imported into the U. S. from Ecuador, the outlets that sold it probably would have bought it at that point,” Califf said.
Shannon Firth has been reporting on fitness policies as MedPage Today’s Washington correspondent since 2014. He is a member of the Enterprise team.