House Democrats to hold hearings, introduce legislation
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Rosa DeLauro of Connecticut, House Appropriations Committee chair and Nancy Pelosi of California, Speaker of the House, discuss the House Democrats $28 Million emergency spending bill. The conference was held at Capitol, Washington, Tuesday May 17, 2022.
J. Scott Applewhite | AP
The House Democrats will host hearings about the U.S. baby formula shortage and then move to adopt legislation to expand Food and Drug Administration inspector staff in order to make sure that infants can eat imported products safely.
Rosa DeLauro is the Chair of the House Appropriations Committee and introduced legislation Tuesday to provide $28 Million in Emergency Funding for the FDA. The funding would be used to accelerate inspections at infant formula plants all over the world.
To ease the crisis, FDA will increase imports of baby formula from other countries. The FDA is increasing imports of baby formula from other countries to help ease the shortage. This stems partly in part because the Abbott Nutrition Sturgis facility in Michigan was closed due to bacteria contamination. The U.S. normally produces 98% of the infant formula that Americans buy, and four manufacturers — Abbott, Mead Johnson Nutrition, Nestle USA and Perrigo — control 90% of the domestic market.
Foreign companies must submit an application to FDA to sell formula in America. The FDA will then assess whether the products are safe for babies and nutritionally sound.
DeLauro claimed that DeLauro was told by the FDA that nine of its inspectors are available to inspect domestic-based formula plants. The FDA also has seven inspection facilities in Europe, and two in Mexico. If additional formula submissions are approved, the FDA might have to inspect even more plants.
These facilities must be inspected. DeLauro (D-Conn.) stated Tuesday that the FDA doesn’t have enough inspectors to inspect these facilities and do so in a timely manner. She also said that the legislation includes money for fraud prevention and supply chain monitoring.
DeLauro indicated that House Democrats were also looking into legislation to increase the FDA’s power to hold businesses accountable. Manufacturers cannot be ordered to recall unfit products by the drug regulator. The regulator can recommend recalls only when safety problems are identified.
The FDA does not have the power to recall. “Recall is what we say, but it’s really a moral issue,” Nancy Pelosi (D-Calif.), said during the news conference.
DeLauro announced that the hearing will be held by Robert Califf (FDA Commissioner) on Thursday at the House Appropriations Subcommittee on Agriculture. According to Frank Pallone (the chairman of the House Energy and Commerce Committee), a second hearing has been scheduled for May 25. This will include Frank Yiannas from the FDA, Frank Yiannas the FDA’s chief food policy officer, and Califf.
Pallone announced that next week will see representatives of infant formula makers Abbott, Gerber, Reckitt and Reckitt at the hearings.
A Monday complaint by the Justice Department in federal court alleges that Abbott sold adulterated infant formula on the marketplace. Four infants, including two who died from bacterial infection after consuming formula manufactured at Sturgis, were hospitalized for their illnesses.
Abbott said Monday in a statement that “no conclusive proof” could be used to connect the infant diseases to its products.
Democrats have intensified their efforts to deal with the crisis and increased their demands for accountability.
Pelosi stated, “I believe there might need to be an indictment,” without specifying which person should be indicted. The office of the Speaker did not respond to inquiries for clarification.
Abbott and FDA came to an agreement to close the plant. Federal court enforcement will be required. Abbott said that it would take approximately two weeks for the plant to reopen. However, FDA approval is required. For product to reach stores, it could take as long as eight weeks.
The consent decree is binding on Abbott for at most five years. For each day the company violates the decree, it is subject to $30,000 of damages.
Abbott will have to close the Sturgis facility again if any of its products test positive for Salmonella and Cronobacter. The company must dispose of the product and find the source of contamination to correct the issue.
Abbott could only restart the plant after it has been cleared by the FDA.
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