Lawmakers slam Abbott at congressional hearing over formula shortage

Members of Congress began a House subcommittee hearing Tuesday by tearing into north suburban-based Abbott Laboratories, accusing the company of negligence.

The hearing Tuesday came amid a nationwide shortage of infant formula caused by supply chain issues and a recall of formulas made at an Abbott plan in Sturgis, Mich.

Abbott recalled a number of infant formulas produced at that facility in February as the U.S. Food and Drug Administration announced that it was investigating complaints of Cronobacter sakazakii infections among four babies who reportedly consumed formula made there. All four were hospitalized, and Cronobacter may have contributed to two babies’ deaths, according to the FDA.

“The tragic situation is unacceptable and, worse, it was totally preventable. This presents a disturbing pattern of negligence,” said subcommittee chairwoman Rep. Diane DeGette, D-Colo., of Abbott.

Rep. Frank Pallone Jr., D-N.J., said more competition among manufacturers is needed so one company doesn’t wield so much power over the supply of infant formula.

“We’re too reliant on too few companies to do the right thing, and when just one of those companies cuts corners we spiral into an emergency,” Pallone said.

Christopher Calamari, president of U.S. and Canada nutrition for Abbott, is slated to testify at the hearing in the coming hours.

Lawmakers also criticized the U.S. Food and Drug Administration for not inspecting the facility sooner and anticipating the shortage.

FDA Commissioner Robert Califf acknowledged during the hearing Wednesday that the FDA was “too slow” to inspect the plant and interview a whistleblower about conditions there.

The FDA first got a complaint in September about an infant who became ill after consuming formula made at the Michigan facility. The FDA inspected the facility from Jan. 31 through March 18 and found five environmental subsamples collected from the Sturgis facility to be positive for Cronobacter sakazakii, though product samples collected by the FDA at the facility were negative for Cronobacter.

Abbott has said the Cronobacter that was found in environmental testing during the investigation was in “non-product contact areas of the facility and has not been linked to any known infant illness.” Abbott has said it has taken action to address issues with processes and procedures found during the FDA inspection.

Abbott announced Tuesday that it would restart production at its Michigan facility June 4 and begin shipping EleCare specialty formulas that were on hold following the recall in coming days. Earlier this month, Abbott entered into a consent decree with the FDA outlining steps the company would have to take before it could restart production of infant formula at a Michigan facility.

The Federal Trade Commission also announced Tuesday it was launching an inquiry into the formula shortage and “the factors that have led to concentration in the infant formula market and the fragility of the supply chains for these crucial products,” according to an FTC news release.

Abbott CEO Robert Ford apologized in an op-ed in The Washington Post over the weekend for Abbott’s role in the formula shortage.

More to come.