By: Angi Gonzalez
WASHINGTON — Lawmakers aren’t just focused on the manufacturers’ role in the baby formula shortage, they’re also looking at whether the Food and Drug Administration bore 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, reflecting 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 to close Abbott Nutrition’s Michigan plant five months after receiving a whistleblower’s report about contamination issues at the facility.
“You blamed COVID-19 staffing issues for preventing FDA leadership from receiving direct copies of the whistle blower report, despite the fact that FDA district offices in Detroit received a hard copy from a confidential informant way back on October 26th,” said Collins during a hearing as she questioned the FDA commissioner.
Testimony from the commissioner identified mail room issues and a failure by internal staff to take the concerns up the chain of command.
“There was not a procedure in place for them to inform the leaders who should have seen it — neither the center director nor the head of the Office of Policy and response,” said FDA Commissioner Dr. Robert Califf while responding to Collins.
The criticism isn’t only coming from lawmakers. A former FDA Associate Commissioner told Spectrum News that there were many missed opportunities.
“FDA absolutely dropped the ball on communications,” said Peter Pitts, a former FDA associate commissioner. “They could have done a much more robust and regular job in communicating to pediatricians to parents, to retailers, to let them know what’s going on, you know, communicating one time 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. It’s a point also being made by Sen. Elizabeth Warren, D-Mass.
“This is a reminder that these oligopolies these when you have a market that only has three major participants in it, that it keeps prices high, which has happened with baby formula in this country,” said Warren.
Pitts said that the American public should start to see the end of the shortage in about a month. However, he added that it’ll be up to Congress to pass legislation to ensure the FDA is better equipped and prepared to handle these situations in the future.
