Degette Says Delays in Remedying Concerns With Abbott's Baby Formula Plant Key Focus of House Panel's Investigation

Statement

U.S. Rep. Diana DeGette (D-CO) -- chair of the House panel that oversees the FDA and is spearheading the investigation into the nationwide shortage of baby formula -- said today that one of the issues the committee is focused on, as it prepares for next week's hearing, is why it took federal regulators so long to identify and remedy concerns raised with Abbott Nutrition's baby formula plant in Sturgis, Michigan.

"The FDA stands for the Food and Drug Administration and for many years the "food' part of that has been woefully neglected," DeGette said during an interview on CNN today ahead of the panel's hearing next week. "What my goal is with this hearing is not only to figure out why it took so long to identify these problems, why it took so long to remedy them, but also to figure out what the FDA needs to have a robust oversight plan, not just because we have a crisis right now, but going forward in the future."

Abbott Nutrition is the nation's largest manufacturer of baby formula and its plant in Sturgis, Michigan -- which the company closed in February 2022 after four children were hospitalized with a rare bacterial infection after consuming products from the facility -- is responsible for producing more than 42% of the nation's baby formula.

A judge today signed off on an agreement reached by Abbott and FDA to reopen the facility in the coming weeks. Abbott says it will take at least two weeks to resume production at the Sturgis plant and another 6 -- 8 weeks before products will once again start shipping to stores.

While noting the agreement was a positive step to alleviating the nation's shortage of baby formula, DeGette called the nearly one-year timeline -- from when FDA was first notified of potential issues with the Abbott plant (in September 2021) to when Abbott says it will be able to once again begin shipping formula to stores (another 8-10 weeks from now) -- "unacceptable."

"All-in-all it's taken about eight months to get to this point," DeGette said today, "and now with this consent decree it's two more weeks to get up and going, and then six to eight more weeks before families can see this on the shelves. That's almost a year since the initial complaints came in, that's really unacceptable. I've been talking to families in Washington, D.C. and in Denver, Colorado who are driving around desperately trying to find food for their infants."

According to reports, FDA was first alerted to potential problems at Abbott's Sturgis plant in September 2021. In October 2021, FDA received a formal whistleblower complaint alleging wrongdoing at the Abbott facility and attempts by the company to hide information from regulators.

Despite the seriousness of the allegation, FDA did not interview the whistleblower until December 2021 and did not inspect the Sturgis plant until January 31, 2022.

The company closed the plant and issued a recall for its products on February 17, 2022.

As the chair of the House Energy and Commerce Oversight and Investigations panel, which is investigating the issue, DeGette announced yesterday that the panel will hold its first hearing on the nationwide shortage on Wednesday, May 25 at 11:00 a.m. ET.

Executives from Abbott Nutrition, Gerber Products Company and Reckitt -- the three largest manufacturers of infant formula in the U.S. -- as well as the head of the FDA, Commissioner Robert Califf -- are all expected to testify.

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