FDA chief struggles to explain its slow response on baby formula

The head of the Food and Drug Administration on Wednesday faced the bipartisan fury of House lawmakers for months over delays in investigating issues at the country’s largest infant formula plant that sparked a continued lack.

FDA Commissioner Robert Califf described a series of setbacks in Congressional testimony that slowed his agency’s response, including a COVID-19 outbreak at the plant and a complaint from a complainant who did not reach out to the FDA leadership because it was apparently lost by mail.

Califf testified before a House subcommittee investigating the shortage, which has turned into a snowball in a national crisis and forced the U.S. military to air transportation supplies to the US from Europe.

The shortage comes in large part from the Abbott plant in Michigan, which the FDA closed in February due to pollution issues. Under the fire of Congress, parents and the media, Califf on Wednesday gave the first detailed account of why it took his agency months to inspect and close the plant despite learning of possible problems as early as September.

FDA response was “too slow”

The FDA’s response was “too slow and there were decisions that were suboptimal along the way,” Califf told lawmakers.

The FDA and President Joe Biden are facing increasing pressure to explain why they did not intervene earlier to avert the supply crisis.

“Why did it need a national media attention attack for the Biden administration to act with a sense of urgency needed to address the shortage of infant formulas?” asked Rep. Morgan Griffith, a Republican from Virginia, the committee’s Republican ranking.

Califf said the agency had been trying to control formula supplies since 2020, when COVID-related disruptions first arose, but regulators have limited visibility into companies’ supply chains.

The House panel also heard from three formula makers, including a senior Abbott Nutrition executive who apologized to parents for the shortage.

“We are disappointed,” said Abbott Vice President Christopher Calamari. “We’re so sorry.”

Calamari repeatedly dodged questions about whether any employees were disciplined or fired for plant problems, which included stagnant water, a leaking roof and damaged equipment.

Dangerous bacteria

FDA staff began delving into the Abbott plant last fall while monitoring various bacterial infections in babies who had consumed formula from the facility. All four cases occurred between September and January, resulting in hospitalizations and two deaths.

The FDA planned to begin inspecting the Sturgis, Michigan plant on Dec. 30, according to Califf’s testimony. But Abbott warned that a dozen plant employees had tested positive for COVID-19 and called for a delay. As a result, the FDA did not begin its inspection until Jan. 31.

After detecting positive samples of a rare but dangerous bacterium in various parts of the plant, the FDA closed the facility and Abbott announced a mass withdrawal of its formula on February 17.

“We knew that the cessation of plant operations would create supply problems, but we had no choice given the unhealthy conditions,” said Califf, who described the problems as “shocking” and “unacceptable.”

Abbott and the FDA have reached an agreement to reopen the plant next week, under which the company must undergo regular external safety audits.

Employees forged records

Califf also struggled to explain the delays in following up on a complaint from a whistleblower alleging numerous security breaches at Abbott’s plant, including employees falsifying records and failing to test the formula before shipping.

Several FDA staff members reviewed the complaint in late October when it was sent to an FDA regional office, but an interview did not take place until two months later, in part due to the complainant’s scheduling conflicts. .

Senior FDA officials finally received the complaint by e-mail, but not until February due to “an isolated failure in the FDA’s mailroom, probably due to staffing problems with COVID-19.” according to FDA testimony. A copy mailed to the acting curator, Dr. Janet Woodcock, has not yet been located.

Political outrage over the shortage has landed directly on the FDA and Califf, which was confirmed as the FDA’s role for the second time in February. The problems have become a political storm for the White House, which has invoked the Defense Production Act and emergency import measures.

The FDA contacted the U.S. Department of Agriculture on Feb. 11 about a possible shortage, just days before Abbott’s withdrawal, according to FDA timeline.

Concern for food

Califf said the FDA had asked for new authorities, funding and staff to track supply chain data that could have helped advance the problem, but noted that Congress has not provided them.

Several lawmakers have long expressed concern that the FDA’s food program, which oversees most U.S. foods except meat, poultry, and eggs, is underfunded and in need of restructuring.

The program has a complicated leadership structure in which there is a director of the FDA’s Center for Food Safety and Applied Nutrition and a separate deputy commissioner for “food policy and response.” The deputy commissioner has a stronger focus on security, but has no direct authority over food center staff or field staff inspecting company plants.

Both officials testified Wednesday, along with Califf.

When Democrat Nanette Diaz-Barragan, a Democrat from California, asked who was in charge of food security, Califf and food center director Susan Mayne gave expanded answers, describing different roles and responsibilities.

“I don’t think anyone is responsible,” Diaz-Barragan said. “I think that shows that it needs to be restructured and we need to be clearer who is ultimately responsible.”

On Wednesday afternoon, Abbott’s Calamari told lawmakers that its company plans to create additional capacity and layoffs in its supply chain to avoid future disruptions. He reiterated the company’s point that the FDA has not established a direct link between diseases reported in infants and samples of bacteria collected from its plant.

After the company restarts production next month, it will be able to produce more formula than before the withdrawal, he noted.

“We’ll learn from that. We’re going to get better as a result of that,” Calamari said.

Reckitt and Gerber executives also testified to their efforts to increase production.