Lawmakers grill FDA for role in formula shortage

WASHINGTON — Lawmakers aren’t just focusing on the manufacturers’ role in the formula shortage, they’re also looking at whether the Food and Drug Administration has some responsibility, according to testimony at two separate hearings on Capitol Hill.

“Infant formula is more regulated than most food products in the United States, which reflects the vulnerability of its consumers, infants and children,” said Rep. Lori Trahan, D-Mass., Who, alongside Sen. Susan Collins, R-Maine, took FDA officials to task.

Collins wanted to know why the FDA waited five months to shut down Abbott Nutrition’s Michigan plant after receiving a whistleblower’s report of contamination issues at the facility.

“You blamed COVID-19 staffing issues for preventing FDA management from receiving direct copies of the whistleblower report, despite FDA district offices in Detroit receiving a hard copy from a confidential informant on October 26,” Collins told a hearing as she questioned the FDA commissioner.

The commissioner’s testimony identified mailroom issues and a failure of internal staff to escalate concerns up the chain of command.

“There was no procedure in place to notify the leaders who should have seen it – neither the director of the center nor the head of the Office of Policy and Response,” said FDA Commissioner Dr. Robert Califf, responding to Collins.

Critics don’t just come from lawmakers. A former FDA associate commissioner told Spectrum News that there were many missed opportunities.

“The FDA absolutely dropped the ball on communications,” said Peter Pitts, a former associate commissioner of the FDA. “They could have done a much more solid and consistent job communicating with pediatricians, parents, retailers, letting them know what’s going on, you know, communicating once saying there might be shortages and then going dark is not helpful.”

Pitts also told Spectrum News that the limited competition within the industry also needs to be addressed. This is a point also raised by Senator Elizabeth Warren, D-Mass.

“It’s a reminder that these oligopolies are there when you have a market that only has three major players, it keeps the prices high, which has happened with infant formula in this country,” he said. Warren.

Pitts said the American public should start to see the end of the shortage in about a month. However, he added that it will be up to Congress to pass legislation to ensure the FDA is better equipped and prepared to handle these situations in the future.

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