Lawmakers Grill FDA Chief on Baby Formula Oversight Amid Shortages

House lawmakers hammered. Robert Califf, head of the Food and Drug Administration, on a budget hearing 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 ordered planes to boost the supply of baby formula from overseas. The agency and the White House have raced in recent days to respond to public outcry over bare grocery store shelves and concerns that desperate parents are rationing their stock or resorting to potentially 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 discovered evidence of a 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, though 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 to provide a timetable for families in relief, Califf listed some efforts underway – including relaxed guidelines for imports and ramped-up domestic manufacturing – and said increased supply to stores would be noticeable in the days ahead. He reiterated a timetable for the reopening of the Abbott plant within two weeks, but said store shelves would not return to normal for weeks.

Representative Rosa DeLauro, a Democrat of Connecticut and chairwoman on the House Committee on Appropriations, was among those panelists pressing Dr. Califf to account for what they characterized as the agency’s sluggish response to obvious problems and an alarming whistle-blower report. Those outlined events leading up to the recall, including a September inspection that turned up evidence of the bacteria in the 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 ?,” Ms. DeLauro asked. “Why did it take four months to pull this formula off the shelf? How many more illnesses and deaths were caused by the FDA’s slow response? “

Beyond the president’s actions, Dr. Califf pointed out that the Justice Department has 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 may hit US stores quickly,” said Dr. Califf said. But he cautioned that distribution would still be a concern for certain areas, especially rural communities.

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

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

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

He was also questioned about findings from the Centers for Disease Control and Prevention and the Agency, based on samples of cronobacter bacteria associated with two of the four infants who fell 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 will continue.

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

Representative Lauren Underwood, Democrat of Illinois, also zeroed in on 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 surgeon. Dr. Califf acknowledges that failing to prioritize baby formula inspection may be a lapse in the agency’s notes to 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 relaxation limit on the types of formulas that can be purchased 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’s level. That includes a $ 76 million increase in food safety funding, which will go toward 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 Senate Republicans. In a notice sent to rank-and-file lawmakers, Republican leaders criticized Democrats for abandoning bipartisan efforts and instead proposed legislation “with no plan to actually fix the problem, 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 investment in safety improvements amid record revenues.

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