Lawmakers Grill FDA Chief on Baby Formula Oversight Amid Shortages

House lawmakers hammered Dr. Robert Califf, head of the Food and Drug Administration, during a budget hearing on Thursday over the agency’s handling of the infant formula shortage exasperating families across the nation.

His appearance before a House subcommittee occurred just a day after President Biden invoked the Defense Production Act and authorized the use of planes to ferry baby formula from overseas to boost supply. The agency and the White House have raced in recent days to respond to the public outcry over bare grocery store shelves and concerns that desperate parents were rationing their stock or resorting to possibly risky DIY mixtures to feed their infants.

The latest shortage stems from the shutdown in February of Abbott Laboratories’ plant in Sturgis, Mich., Where the FDA had discovered evidence of a potentially deadly bacteria called cronobacter sakazakii. The company launched a major recall that has resulted in gaping holes in the supply chain. Federal agencies have been investigating several cases of illness in babies beginning last fall, including two deaths, although no definitive link to the formula has been established.

Dr. Califf acknowledged to lawmakers that the agency was conducting an internal review to see if any errors were made. Pressed by lawmakers for a timetable to provide relief for families, Dr. Califf listed some efforts underway – including relaxed guidelines for imports and ramped up domestic manufacturing – and said increased supplies to stores would be noticeable in days. He reiterated that the Abbott plant should reopen within two weeks, but said store shelves would not return to normal for weeks.

Representative Rosa DeLauro, a Democrat of Connecticut and chairwoman of the House Committee on Appropriations, was among those panel members pressing Dr. Califf to account for what they characterized as the agency’s sluggish response to clear problems and an alarming whistle-blower report. She outlined events leading up to the recall, including a September inspection that turned up evidence of the bacteria in finished formula and a whistle-blower report raising a battery of concerns.

“It all begs the question of why did the FDA not spring into action?” DeLauro asked. “Why did it take four months to pull this formula off the shelf? How many more illnesses and deaths were caused due to the FDA’s slow response? ”

Beyond the president’s actions, Dr. Califf pointed out that the Justice Department reached a settlement with Abbott requiring heightened safety measures and an independent overseer at the plant.

“With these three recent actions, we anticipate that additional products can quickly hit US stores,” Dr. Califf said. But he cautioned that distribution would still be a concern for certain areas, especially rural communities.

The baby formula shortage began during the pandemic and worsened after the recall at the Abbott plant, which makes an estimated 25 percent of the US supply. As baby formula stock began to fall in recent months, sales began to surge, most likely reflecting a wave of panic buying.

Ms. DeLauro also grilled Dr. Califf over whether the FDA’s plan to ease barriers to foreign formula imports would let unsafe products into the country, given voluntary safety guidelines that allow for “third-party” certification of standards.

Dr. Califf said the agency had the discretion to reject any applicant. “We will not let infant formula into the US that is not safe,” he said.

He was also questioned about findings by the Centers for Disease Control and Prevention and the agency, based on samples of the cronobacter bacteria associated with two of the four infants who fell ill in recent months. Those were compared with five strains of the bacteria found at the Sturgis plant, Dr. Califf said. The agencies and Abbott have said there was no match between any of them.

Dr. Califf said the FDA investigation would continue.

“Saying the cases came directly from that plant is something that we can not say until the investigation is completely completed,” he said.

Representative Lauren Underwood, Democrat of Illinois, also zeroed in on delays at the Abbott plant, asking why the agency had not deemed an on-site inspection critical, even though domestic on-site reviews had been suspended because of the Omicron surge. Dr. Califf acknowledged that failing to prioritize the baby formula inspection might be a lapse the agency notes in its review.

In the House and the Senate, various proposals are being considered that would require more oversight of food safety and improve the supply chain for formula.

On Wednesday, the House approved an emergency infusion of $ 28 million for the FDA and a bill to relax limits on the types of formula that can be purchased with benefits from the Special Supplemental Nutrition Program for Women, Infants and Children, known as WIC. About half the formula sold in the United States is purchased with WIC benefits. The Senate is expected to approve the changes to the federal food aid program.

Dr. Califf asked lawmakers to approve an $ 8.4 billion budget, which would be $ 2.1 billion above last year level. That includes a $ 76 million increase in food safety funding, which would go towards improving technology to quickly trace food borne illnesses to their source and other efforts to reduce toxins in food.

But additional funding for the FDA was expected to meet stiff resistance from the Senate Republicans. In a notice sent to rank-and-file lawmakers, Republican leaders criticized Democrats for abandoning bipartisan efforts and instead offering legislation “with no plan to actually fix the problem, all while failing to hold the FDA accountable.”

The House Energy and Commerce Committee has booked top FDA and formula company executives for a hearing next Wednesday on formula safety and supply.

Senator Ron Wyden, a Democrat from Oregon, also announced a Senate Finance Committee investigation into Abbott’s investments in safety improvements amid record revenues.

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