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New bill would give FDA more authority to resolve formula shortage, ensure families can access life-sustaining products

Washington, D.C. – Today, U.S. Senators Bob Casey (D-PA), Sherrod Brown (D-OH), Tammy Duckworth (D-IL), Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA) introduced a bill to protect families and patients who rely on infant formula and other essential sources of nutrition (ESN). The Protect Infants from Formula Shortages Act would safeguard the availability of these products by requiring manufacturers to notify the Food and Drug Administration (FDA) of potential supply disruptions and give the FDA additional tools to proactively work with manufacturers to help prevent or mitigate potential shortages. At present, 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.

“Parents and families across the country are feeling desperate and scared. There is no greater fear than not being able to feed your child or of feeding your child contaminated formula. Congress has a responsibility to do everything we can to ensure formula is on shelves and parents can feed their kids,” said Senator Casey. “I am introducing the Protect Infants from Formula Shortages Act to avoid another massive disruption in availability of life-saving and life-sustaining formula and other products. I will continue to push Abbott and the FDA to get the answers we need to make sure no family ever has to go through the fear and frustration parents are feeling now.”

“This infant formula supply shortage has placed an unacceptable burden on parents and caregivers and has put the health of too many babies and infants at risk. I am proud to introduce this legislation with Sen. Casey to ensure this never happens again and that families have access to the essential formula they need,” said Senator Brown.

“Our nation's infant formula shortage is alarming, and we must do all we can to ensure it doesn’t happen again,” said Duckworth. “Shortages like these can have serious consequences for a child’s growth and development—especially in the first year of their life—and it’s unacceptable. That’s one of the many reasons I’m proud to join my colleagues in helping Senator Casey introduce our commonsense legislation to prevent these kinds of shortages in the future and support working families across the nation.”

“It is imperative that we take all steps necessary to prevent another formula shortage from happening in the United States,” said Senator Gillibrand. “75 percent of babies in the United States are fed formula at some point in their first six months of life. So this is not just a problem for some babies, it’s a problem for the vast majority of infants and their families. This urgently needed bill will help prevent Americans from facing such a shortage again.”

“The infant formula shortage has created a crisis for the babies, children, and families who rely on this essential product. I'm glad to join Senator Casey and my colleagues in introducing this legislation to prevent future shortages and help ensure American families never have to face a crisis like this again,” said Senator Warren.

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; and
  • 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 the recall was announced, Senator Casey has advocated on behalf of consumers to get answers. Below is a timeline of his work on the issue:

February 24, 2022 : Senator Casey, Chair of the Subcommittee on Children and Families on the Senate Health, Education, Labor, and Pensions (HELP) Committee joined Senator Patty Murray (D-WA), Chair of the Senate HELP Committee, to send a letter to Abbott requesting documents and more detail on the recall.

March 22, 2022 : Senators Casey and Murray responded to the troubling Form 483s from three FDA inspections conducted at Abbott Nutrition’s facility.

April 8, 2022 : Senator Casey and Senator Sherrod Brown (D-OH) sent a letter to FDA Commissioner Califf pressing for answers on their actions and plans to investigate the Abbott reports.

April 29, 2022 : Senator Casey raised alarms on the whistleblower report from Abbott.

May 13, 2022 : Senator Casey and Senator Murray led 30 Democratic colleagues to push infant formula manufacturers to make every effort possible to get formula on the shelves.

Read more about the Protect Infants from Formula Shortages Act here.