FDA chief blames coronavirus, mail mix-up for delayed action
WASHINGTON » The head of the Food and Drug Administration said Wednesday that efforts to investigate problems at a baby-formula plant linked to the nationwide shortage were slowed by COVID-19, scheduling conflicts and even a missing piece of mail.
FDA Commissioner Robert Califf in congressional testimony laid out a series of setbacks that slowed his agency’s response by months, including a whistleblower complaint that didn’t reach FDA leadership due to a “mailroom failure.”
Califf testified before a House subcommittee probing the shortage, which has forced the U.S. to begin airlifting products from Europe while many parents still hunt for scarce supplies in stores.
About 2 million cans of infant formula made by United Kingdom-based company Kendal Nutricare are expected to arrive on U.S. store shelves starting next month after receiving special clearance from the FDA. The company has 40,000 cans in stock ready for immediate dispatch and the government is evaluating ways to get them on U.S. soil as quickly as possible.
A Danone SA executive said the company is also helping U.S. authorities prepare for shipments of its specialized formula.
Califf told lawmakers FDA’s response was, “Too slow and there were decisions that were suboptimal along the way.”
The FDA and President Joe Biden face mounting pollical pressure to explain why they didn’t intervene earlier to try to address the supply problems. The oversight subcommittee’s ranking Republican quickly zeroed in on the slow response.
“Why did it take an onslaught of national media attention for the Biden administration to act with a sense of urgency required to address an infant-formula shortage?” asked Rep. Morgan Griffith, R-Virginia.
The shortage mostly stems from Abbott Nutrition’s Sturgis, Mich. plant, the largest in the U.S., which the FDA shut down in February due to contamination.
“We knew that ceasing plant operations would create supply problems but we had no choice given the insanitary conditions,” Califf said in opening testimony.
Califf gave the first detailed account of why his agency took months to inspect the plant despite learning of potential problems as early as September.
FDA staff began honing in on Abbott’s plant last fall while tracking several bacterial infections in infants who had consumed formula from the facility. The four cases occurred between September and January, leading to hospitalization and two deaths.
Califf told lawmakers the
FDA began planning to visit the plant in early December, with inspectors set to arrive on Dec. 30. But Abbott said that about a dozen of its employees had recently tested positive for COVID-19 and requested a delay. As a result, the FDA didn’t begin its inspection until Jan. 31.
After detecting positive samples of bacteria in multiple parts of the plant, the FDA closed the facility, and Abbott announced a massive recall of its formula on Feb. 17.
Abbott and the FDA have reached an agreement to reopen the plant next week, requiring the company to regularly undergo outside safety audits.
Califf also laid out the agency’s monthslong timeline responding to an October whistleblower complaint alleging numerous safety violations at Abbott’s plant, including employees falsifying records.
Several FDA staffers reviewed the complaint in late October, but officials didn’t request an interview until early December. Because of conflicts with the whistleblower’s schedule, the interview didn’t take place until Dec. 22, according to the FDA testimony.
Senior FDA officials eventually received emailed copies of the complaint, but not until February due to “an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the prepared remarks.