FDA chief details infant formula factory inspection delays – WSB-TV Channel 2


WASHINGTON — (AP) — Federal plans to inspect a baby formula factory tied to the national shortage have been slowed by COVID-19, scheduling conflicts and other logistical issues, according to prepared testimony from the head of the Food and Drug Administration.

FDA Commissioner Robert Califf is expected to answer questions from House lawmakers on Wednesday about the events that led to the formula shortage, which forced the United States to start airlifting products from Europe. while many parents are still looking for scarce supplies.

The problem is largely linked to problems at Abbott Nutrition’s Michigan plant, the largest in the United States, which the FDA closed in February due to contamination. In prepared remarks, Califf gives the first detailed account of why it took his agency months to inspect the plant after first learning of potential problems last fall.

Members of an energy and trade subcommittee will also hear from three infant formula makers, including a senior Abbott executive.

FDA staff began to focus on problems at the Abbott plant after tracking four bacterial infections in infants who had consumed formula from the facility. The cases occurred between September and January, causing four hospitalizations, including two deaths.

Califf will tell lawmakers that the FDA began planning to visit the Sturgis, Michigan plant in early December, with inspectors expected to arrive Dec. 30. But Abbott said about a dozen of its employees had recently tested positive for COVID-19 and requested a delay. As a result, the FDA did not begin its inspection until January 31.

After detecting positive bacteria samples in several parts of the plant, the FDA closed the facility and Abbott announced a mass recall of its formula on February 17.

Abbott and the FDA reached an agreement to reopen the plant next week, requiring the company to undergo regular external safety audits. But Califf’s testimony suggests the FDA’s efforts to reopen the plant were slowed by negotiations with Abbott, which had to be codified in a court settlement.

“Because this was a negotiation process with a regulated company, the US government did not completely control the timing,” Califf’s written testimony states.

The FDA also faced questions about its timeline for reviewing an October whistleblower complaint alleging numerous safety violations at the Abbott plant, including employees falsifying records and failing to test the formula. Califf’s testimony details a two-month gap between when regulators received the report and when they actually interviewed the whistleblower.

Several FDA staff members reviewed the complaint in late October, but officials did not request an interview until early December. Due to conflicts with the whistleblower’s schedule, the interview did not take place until December 22, according to FDA testimony.

Senior FDA officials did not receive a copy of the whistleblower’s complaint until February due to “an isolated failure in the FDA mailroom, likely due to staffing issues related to the COVID-19,” according to prepared remarks.

Califf is the only administration official to testify so far on the shortage, which has become a major political handicap for President Joe Biden. Behind the shortage lie other distinct factors, including supply disruptions caused by COVID-19 and industry consolidation that has made the U.S. formulas market vulnerable to disruptions.

An Abbott executive is expected to tell the committee that his company will invest in additional capacity and supply chain safeguards to avoid future disruptions. After the company restarts production next month, it will be able to produce more formula than before the recall, according to remarks prepared by Abbott senior vice president Christopher Calamari.

The company will reaffirm its claim that there is no direct link between its formula and childhood infections investigated by the FDA. Agency regulators said the small number of cases and incomplete testing data make it difficult to draw a direct link between the illnesses and the Abbott plant.

Executives from Reckitt and Gerber are also set to testify.


The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.


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