Lawmakers Question FDA Chief Over Baby Formula Oversight Amid Shortage

House lawmakers criticized Dr. Robert Califf, head of the Food and Drug Administration, during a budget hearing Thursday for the agency’s handling of an infant formula shortage that is exasperating families across the country. .

His appearance before a House subcommittee came just a day after President Biden invoked the Defense Production Act and authorized the use of planes to transport baby formula from abroad to increase supply. The agency and the White House have scrambled in recent days to respond to public outcry over empty grocery store shelves and concerns that desperate parents were rationing their stock or turning to possibly risky homemade mixes to feed children. their babies.

The most recent shortage stems from the closure in February of the Abbott Laboratories plant in Sturgis, Michigan, where the FDA discovered evidence of a potentially deadly bacteria called cronobacter sakazakii. The company launched a major recall that has resulted in huge holes in the supply chain. Federal agencies have been investigating several cases of illness in infants since last fall, including two deaths, although a definitive link to formula has not been established.

Dr. Califf acknowledged to lawmakers that the agency was conducting an internal review to see if mistakes were made. Pressed by lawmakers for a timeline to provide relief to families, Dr. Califf listed some ongoing efforts, including relaxed guidelines for imports and increased domestic manufacturing, saying increased supplies to stores will be You will notice in days. He reiterated that the Abbott plant should reopen within two weeks, but said store shelves would not be back to normal for weeks.

Rep. Rosa DeLauro, a Democrat from Connecticut and chair of the House Appropriations Committee, was among the panel members who pushed Dr. Califf to account for what they characterized as the agency’s slow response to clear problems. and an alarming report from whistleblowers. She described the events leading up to the recall, including an inspection in September that found evidence of the bacteria in finished formula and a whistleblower report that raised a number of concerns.

“It all begs the question of why the FDA didn’t take action,” Ms. DeLauro asked. “Why did it take four months to get this formula off the shelf? How many more illnesses and deaths have occurred due to the FDA’s slow response?

Beyond the president’s actions, Dr. Califf noted that the Justice Department reached an agreement with Abbott that calls for increased security measures and an independent supervisor at the plant.

“With these three recent actions, we anticipate that additional products may quickly reach US stores,” said Dr. Califf. But he warned that distribution would remain a concern for certain areas, especially rural communities.

Baby formula shortages began during the pandemic and worsened after the recall at the Abbott plant, which produces about 25 percent of the U.S. supply, as baby formula stocks began to fall in In recent months, sales have started to rise, most likely reflecting a wave of panic buying.

Ms. DeLauro also questioned Dr. Califf about whether the FDA’s plan to ease barriers to imports of foreign formula would allow unsafe products to enter the country, given voluntary safety guidelines that allow certification of standards by FDA. of “third parties”.

Dr. Califf said the agency had the discretion to reject any applicant. “We will not allow 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 babies who fell ill in recent months. Those were compared to five strains of bacteria found at the Sturgis plant, Dr. Califf said. The agencies and Abbott have said there was no match between either of them.

Dr. Califf said the FDA investigation would continue.

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

Rep. Lauren Underwood, D-Illinois, also focused on the delays at the Abbott plant, asking why the agency had not deemed an on-site inspection critical, even though national on-site reviews had been suspended due to increased from Omicron. Dr. Califf acknowledged that failing to prioritize inspection of infant formula could be a mistake the agency points to in its review.

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

On Wednesday, the House approved a $28 million emergency infusion 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 of 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 pass a budget of $8.4 billion, which would be $2.1 billion above last year’s level. That includes a $76 million increase in funding for food safety, which would go toward improving technology to quickly trace foodborne illness to its 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 offering legislation “with no plan to fix the problem, all while failing to hold the FDA accountable.”

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

Sen. Ron Wyden, an Oregon Democrat, also announced a Senate Finance Committee investigation into Abbott’s investments in security improvements amid record revenue.

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