WASHINGTON, D.C. – This week, a bipartisan majority in the Senate Health, Education, Labor and Pensions (HELP) Committee voted in support of advancing legislation that includes Brown’s provisions based on his Protect Infants from Formula Shortages Act. The bill would require manufacturers to notify the Food and Drug Administration (FDA) of potential formula supply disruptions and give the FDA additional tools to proactively work with manufacturers to help prevent or mitigate potential shortages. Currently, the agency lacks visibility into disruptions that could cause shortages, limiting its ability to work with manufacturers to adequately prepare for and respond to supply chain disruptions. Brown introduced the legislation with U.S. Senators Bob Casey (D-PA), Tammy Duckworth (D-IL), Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA) to protect families and patients who rely on infant formula and other essential sources of nutrition (ESN).
“No parent should live in fear they won’t be able to feed their newborn child. We need to get formula back on the shelves, and make sure that parents never face these shortages again. I thank my colleagues on the Senate HELP Committee, especially Senator Casey, for their leadership and for including these provisions in their final bill,” said Senator Brown. “I’m urging Senate leadership to bring this legislation to the floor for a vote to ensure this never happens again and that families have access to the essential formula they need.”
The Protect Infants from Formula Shortages Act:
Requires manufacturers of ESN to provide timely notification of known circumstances that are likely to lead to meaningful disruption in their domestic supply;
Allows the FDA to expand and accelerate notification requirements for certain foods during public health emergencies;
Directs manufacturers of ESN to develop risk management plans for the supply of their product;
Gives the FDA authority to request records in advance or in lieu of an in-person inspection, and requires that manufacturers of ESN comply with these requests.
This legislation is endorsed by the American Academy of Pediatrics, the National WIC Association, North American Society For Pediatric Gastroenterology, Hepatology & Nutrition, the National PKU Alliance and National PKU News.
Since Abbott Nutrition announced a recall and as families have faced increasingly dire shortages, Senator Brown has advocated on behalf of Ohio parents to get answers and increase the supply of formula.
Last month, Brown joined a group of his colleagues in sending letters to Mardi Mountford, President of the Infant Nutrition Council of America, calling on infant formula manufacturers to make every effort possible to get parents and families the formula they need to feed their kids, and to President Biden, urging him to assign a coordinator, within the White House on infant formula to address the shortage and lead a national strategy to make the infant formula supply chain more resilient.
In April, following multiple reports of illness and two tragic deaths linked to recalled infant formula manufactured by Abbott Nutrition, Brown and Sen. Bob Casey (D-PA) sent a letter to FDA Commissioner Robert Califf demanding information on the FDA’s actions and plans to investigate these reports and to prevent other infants from falling ill.
Read more about the Protect Infants from Formula Shortages Act here.
