Grill Legislators FDA Director for Oversight of Baby Formulas In the Midst of Shortages

House lawmakers criticized Dr Robert Califf, head of the Food and Drug Administration, during a budget hearing on Thursday over the agency’s handling of formula shortages for babies. families across the country.

His appearance before a House subcommittee comes just a day after President Biden invoked the Defense Production Act and authorized the use of aircraft to ship infant formula from abroad to boost supply. The agency and the White House have raced in recent days in response to public outcry over bare grocery shelves and concerns that desperate parents are rationing merchandise. their own or using potentially risky DIY mixes to raise their children.

The latest shortage stems from the February closure of the Abbott Laboratories plant in Sturgis, Mich., where the FDA discovered evidence of a potentially deadly bacteria called cronobacter sakazakii. The company conducted a major recall that resulted in a hole in the supply chain. Federal agencies have been investigating several cases of infant illness since last fall, including two deaths, although there is no firm link to public formula. awake.

Dr. Califf acknowledged to lawmakers that the agency was conducting an internal review to see if there were any flaws. Pressed by lawmakers for a timetable to bail out families, Dr. Califf listed a number of efforts underway – including easing guidelines on imports and boosting production. domestic production – and said an increase in supply to stores would be noticeable in the next few days. He reiterated that the Abbott factory would reopen within two weeks, but said store shelves would not return to normal for weeks.

Representative Rosa DeLauro, a Connecticut Democrat and chair of the House Committee on Expropriation, was among the panel members who pressed Dr. Califf to account for what they saw as treason. The agency’s slow response to obvious problems and an alarming report. She outlined the events leading up to the recall, including a test in September that turned up evidence of bacteria in finished formula and a whistleblower report that raised concerns.

“It all begs the question, why hasn’t the FDA taken action?” Ms. DeLauro asked. “Why did it take four months to pull this recipe off the shelf? How many more illnesses and deaths are due to the slow FDA response? ”

In addition to the president’s actions, Dr. Califf pointed out that the Justice Department had reached an agreement with Abbott that required higher safety measures and an independent oversight at the plant.

“With three recent actions, we anticipate that additional products could quickly reach stores in the US,” said Dr. Califf. However, he cautioned that distribution would still be a concern for certain areas, particularly rural communities.

Infant formula shortages began during the pandemic and worsened following a recall at the Abbott factory, which accounts for 25% of the US supply. As supplies of infant formula have begun to decline in recent months, sales have begun to skyrocket, most likely reflecting a wave of panic buying.

Ms. DeLauro also asked Dr. Califf about whether the FDA’s plan to reduce barriers to foreign formula imports would allow unsafe products to enter the country, with natural safety principles in place. willing to allow “third party” certification of the standard.

Dr. Califf said the agency had the sole discretion to deny any applicant. “We’re not going to let unsafe infant formula enter the United States,” he said.

He was also questioned about findings by the Centers for Disease Control and Prevention and the agency, based on samples of cronobacter bacteria associated with two out of four infants who fell ill in recent months. They were compared with five strains of bacteria found at the Sturgis plant, Dr. Califf said. The agencies and Abbott have said that there has not been any match between any of them.

Dr. Califf said the FDA investigation will continue.

“To say that the cases come directly from that factory is something that we cannot say until the investigation is complete,” he said.

Representative Lauren Underwood, an Illinois Democrat, also objected to the Abbott plant’s delay, asking why the agency didn’t consider the on-site inspections important, despite the on-site reviews in The water was suspended due to the increase in Omicron. Dr. Califf acknowledged that failing to prioritize testing for infant formula could have been a mistake, which the agency noted in its review.

In the House and Senate, various proposals are being considered that call for greater oversight of food safety and improved formula supply chains.

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

Dr. Califf asked lawmakers to pass a budget of $8.4 billion, $2.1 billion more than last year’s level. That includes a $76 million increase in food safety funding, which will go toward improving technology to quickly trace foodborne illness and other efforts to reduce toxins in food.

But additional funding for the FDA is expected to face stiff opposition from Senate Republicans. In a notice sent to legislators and profilers, Republican leaders criticized Democrats for abandoning bipartisan efforts and instead introducing legislation that “has no plan.” plan to actually fix the problem, all while not blaming the FDA.”

The House Energy and Commerce Committee has asked top FDA and formula milk company executives to participate in 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 revenue.

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