VIDEO: Senator Peters Advocates for Efforts to Help Prevent Future Infant Formula Shortages at Hearing with FDA Commissioner

WASHINGTON, DC – During a Senate Appropriations Subcommittee hearing with the U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, U.S. Senator Gary Peters (MI) advocated for efforts to help prevent future infant formula shortages, including bipartisan legislation Peters is working to introduce in the Senate. These efforts are in response to multiple FDA warning letters after a recall triggered a nationwide infant formula shortage in 2022. 

“In 2021, the FDA found that some infant formula products had been released to the public while contaminated with Cronobacter,” said Peters. “This didn’t just cause widespread panic and a nationwide formula shortage. It also revealed the effects of a glaring problem, that the FDA does not currently have the authority to inspect infant formula until after the product has left the manufacturer’s control.”

“The FDA’s two past budgets have requested additional authority to require industry to conduct testing of final infant formula products and I’ve been working on legislation to provide this authority that is so essential for you to protect infant formula,” Peters continued. “The bill would require infant formula manufacturers to test for key contaminants before releasing their products out to the public and give positive test results to the FDA.”

In response, Commissioner Califf said, “You are correct. There is no requirement of reporting to the FDA the results of testing that companies do even if they find bacteria... But it would really help us a lot if there were requirements for testing, and if the tests are positive, that we be notified.”

“In the case of the recall that we had, there were just a lot of bad conditions in that one plant. We would have known about that a lot earlier had we known about the results of testing that companies do,” Califf continued.

Peters also secured support for his Shandra Eisenga Human Cell and Tissue Products Safety Act, which would help prevent the spread of tuberculosis (TB) through transplanted human cell and tissue products (HCTP). The legislation is named in honor of Shandra Eisenga of Marion in Osceola County, Michigan, who passed away on August 10, 2023 from post-surgical tuberculosis after receiving an infected graft.

“Last year, one of my constituents, Shandra Eisenga, lost her life after being treated for a tuberculosis infection with a contaminated bone graft from Aziyo Biologics,” Peters said. “Her case just shows how dangerous it is when TB is spread through the transplantation of human cells, tissues, as well as cellular-based products.”

“I remain concerned that we are not doing enough to stop the spread of TB through transplantation of human cells, tissues, and cellular-based products, and that’s why I’ve introduced legislation that would conduct an educational campaign about the risks associated with human cell and tissue transplants, and it would allow for civil monetary penalties for companies that violate compliance standards, similar to that of traditional medical devices or medical products,” Peters continued.

Commissioner Califf responded, “The issue of cell and tissue therapy is one of the most promising things that we have… in developing treatments to prevent and treat human disease, but it has a downside. It gets very complicated because it intersects with practice of medicine issues, and very complicated interpretations of regulations about the type of tissue used and how much it falls into a category more like a drug or device... So, your efforts to clarify this are much appreciated. It’s a focus of ours. The civil monetary penalties will be a big help to us...”

“I also applaud your efforts in education. It is a complicated area. When you hear about stem cells and cell therapy, it is very exciting. But the details are important,” Califf continued.

To watch the full video of Senator Peters’ questioning, click HERE or below.  

In February 2024, Peters introduced the bipartisan, bicameral Shandra Eisenga Human Cell and Tissue Products Safety Act following an outbreak of tuberculosis in transplanted bone graft material led to serious health complications and deaths for patients across the country, including in Michigan. The bill – which he introduced with U.S. Senator Debbie Stabenow (MI) and U.S. Representatives John Moolenaar (MI-02) and Debbie Dingell (MI-06) – would require a report to Congress on HCTP accreditation, FDA inspection activities, and recommendations on potential guidance to be issued. It also would create a civil penalty for companies that have violations not meeting compliance standards. It would additionally conduct a national, evidence-based educational campaign to increase public and health care provider awareness regarding the risks of HCTP transplants so that patients understand their risks.

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