House lawmakers killed Dr. Robert Calif, head of the Food and Drug Administration, during a budget hearing on Thursday over how the agency copes with the lack of infant formula, which is irritating families across the country.
His appearance before a House subcommittee came just a day after President Biden demanded the Defense Manufacturing Act and allowed planes to be used to transport baby formula from abroad to increase supplies. The agency and the White House have in recent days tried to respond to public outcry over the bare shelves of grocery stores and concerns that desperate parents have normalized their stocks or resorted to perhaps risky formulas to feed their children.
The latest flaw is caused by the February closure of the Abbott Laboratories plant in Sturgis, Michigan, where the FDA has found evidence of a potentially deadly bacterium called cronobacter sakazakii. The company has launched a major recall that has led to loopholes in the supply chain. Federal agencies have investigated several cases of infant disease that began last fall, including two deaths, although a definitive link to the formula has not been established.
Dr Calif admitted to lawmakers that the agency was conducting an internal audit to see if any mistakes had been made. Under pressure from lawmakers to schedule a schedule of assistance to families, Dr Calif listed some of the efforts being made – including easing import recommendations and boosting domestic production – and said the increase in store supplies would be noticeable in a few days. He reiterated that the Abbott plant should reopen within two weeks, but said store shelves would not return to normal within a few weeks.
A spokeswoman for Rosa DeLavre, a Democrat from Connecticut and chair of the House Appropriations Committee, was among those members of the commission who pressured Dr. Caliph to explain what they described as the agency’s sluggish response to obvious problems and the informant’s alarming report. She spoke about the events that led to the recall, including the September inspection, which found evidence of bacteria in the finished formula, and the informant’s report, which raises a number of concerns.
Read more about baby formula deficiency
“All of this raises the question of why the FDA didn’t take action?” Ms. DeLavra asked. “Why did it take four months to take that formula off the shelf? How many more illnesses and deaths were caused by the slow response of the FDA? ”
In addition to the president’s actions, Dr. Calif noted that the Ministry of Justice has reached an agreement with Ebat that requires heightened security measures and an independent overseer at the plant.
“With these last three actions, we expect that additional products can quickly hit stores in the U.S.,” Dr. Calif said. But he warned that the distribution would continue to bother some areas, especially rural settlements.
The shortage of infant formula began during the pandemic and worsened after the withdrawal of the Abbott plant, which accounts for about 25 percent of U.S. supplies. As stocks of baby formulas began to fall in recent months, sales began to rise, most likely reflecting a wave of buying panic.
Ms. DeLavra also agreed with Dr. Caliph on whether the FDA’s plan would ease barriers to the import of foreign formulas of unsafe products into the country, given voluntary safety guidelines that allow for third-party certification.
Dr Calif said the agency has the right to deny any applicant. “We will not allow infant formula in the United States, which is not safe,” he said.
He was also interviewed about the findings of the Centers for Disease Control and Prevention and the agency based on samples of chronobacterial bacteria associated with two of the four babies who fell ill in recent months. They were compared to five strains of bacteria found at the Sturgis plant, Dr. Caliph said. The agency and Abbott said there were no coincidences between them.
Dr Calif said the FDA investigation would continue.
“To say that the cases went directly from this plant, we can not say until the investigation is fully completed,” he said.
Navigating the baby formula shortage in the US
A growing problem. The shortage of infant formulas across the country – partly caused by supply chain problems and exacerbated by the withdrawal of baby food maker Abbott Nutrition – has caused parents to be confused and worried. Here are some ways to manage this uncertainty:
A spokeswoman for Lauren Underwood, a Democrat from Illinois, also spoke about the delays at the Abbott plant, asking why the agency did not consider the on-site inspection critical, even though internal on-site inspections were suspended due to the Omicron surge. Dr Caliph acknowledged that the lack of priority in inspecting baby formula could be a mistake, the agency said in its review.
The House of Representatives and Senate are considering various proposals that will require greater oversight of food safety and improvements in the formula supply chain.
On Wednesday, the House of Representatives approved an emergency $ 28 million infusion for the FDA and a bill to ease restrictions on the types of blends that can be purchased through a special supplementary nutrition program for women, babies 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 changes to the federal food aid program.
Dr Calif asked lawmakers to approve a budget of $ 8.4 billion, up $ 2.1 billion from last year. This includes an increase in food security funding of $ 76 million, which will go towards improving the technology of rapid tracking of foodborne diseases to their source and other efforts to reduce food toxins.
But additional FDA funding was expected to meet fierce opposition from Republicans in the Senate. In a statement sent to ordinary lawmakers, Republican leaders criticized Democrats for abandoning bipartisan efforts and instead proposed legislation “without a plan to actually address the issue without bringing the FDA to justice.”
The House Energy and Commerce Committee has ordered hearings of top FDA executives and formula companies next Wednesday on security and formula supplies.
Senator Ron Widen, a Democrat from Oregon, also announced an investigation by Senate finance committees into Abbott’s investment in improving security amid record revenues.