Top officials at the Food and Drug Administration admitted they took too long to respond to a baby formula shortage and were hobbled by bad decisions and problems related to COVID-19, including a whistleblower report about a formula factory that was lost in the mail.
Top FDA officials and company executives from the nation’s three baby formula manufacturers answered questions Thursday from House lawmakers about a massive shortage triggered by the closure of one of the nation’s largest production plants and exacerbated by a slow government response.
FDA Commissioner Robert M. Califf told lawmakers that government regulators made mistakes along the way that led to the prolonged production problems that have left shelves empty of baby formula.
“The result is not what we would have wanted,” Mr. Califf said.
When asked to rate his performance on a scale of 1 to 10, Mr. Califf gave himself “a 4 or a 5” but said FDA workers were on the job “nights and weekends working on this.”
A key whistleblower report from a fired employee of a Sturgis, Michigan, formula plant that cited critical safety violations was lost in the FDA’s mail system, Mr. Califf said, possibly because of staff shortages caused by the COVID-19 pandemic.
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The mail glitch kept top FDA officials from finding out about the report for months.
It was mailed to the FDA’s Detroit office on Oct. 26, but top FDA officials did not see it until Feb. 14.
FDA inspectors also delayed an inspection of the Sturgis plant in January because of repeated COVID-19 outbreaks among plant employees. The inspection was postponed as the FDA received three reports of infant illnesses with possible ties to powdered formula.
“The FDA’s timeliness of interviewing the whistleblower and getting into the facility for a for-cause inspection was too slow, and some decisions in retrospect could have been more optimal,” Mr. Califf told lawmakers.
Mr. Califf said FDA officials are conducting an investigation into the government’s response to the whistleblower report, including the mail mishap, as well as the pace of the agency’s effort to resolve safety problems at the Sturgis plant to speed the plant’s reopening.
The Sturgis plant, owned by Abbott Nutrition, produces 20% of all formula on the U.S. market.
It was closed in February after infants were sickened with Cronobacter sakazakii bacteria after consuming powdered formula produced at the facility, although testing showed no direct ties to the plant.
Abbott at that time issued a major formula recall at the request of the FDA.
The FDA said a six-week government inspection of the plant found “significant, fundamental sanitation, building, and equipment issues,” as well as the presence of Cronobacter sakazakii, but not the specific strain that sickened the four infants.
Mr. Califf described the violations at the plant, which included a leaking ceiling, as “beyond the pale.”
The plant remains shuttered while Abbott satisfies a safety and sanitation agreement struck just last week with the Department of Justice.
Mr. Califf said the plant could be open by June 4. After that, company officials said, it will take six to eight weeks to begin moving formula onto store shelves.
Responding to angry lawmakers about the slow pace of the plant overhaul and reopening, Mr. Califf said the FDA “didn’t meet the need” and blamed “a combination of leadership, money and technology.”
President Biden this month invoked the rarely used Defense Production Act to enable U.S. military planes to ship formula from overseas.
Abbott Senior Vice President Christopher J. Calamari told lawmakers that the company had addressed 43 FDA “observations” to meet the June 4 reopening goal.
Mr. Calamari said Abbott is reviewing the whistleblower report.
“We don’t know those allegations to be true,” Mr. Calamari said.
Abbott officials said they learned about the whistleblower report in April, six months after it was sent to the FDA’s Detroit office. They said the report was written by an employee who had been fired over safety violations.
Neither Mr. Califf nor Mr. Abbott provided specific reasons why the plant was not able to reopen sooner.
Mr. Abbott told lawmakers that the plant immediately addressed the violations found in the FDA inspection, which began on Jan. 31 and concluded on Feb. 18.
Mr. Califf, when asked about the three-month gap between the plant closure and the reopening agreement, told lawmakers that the plant violations were so bad that the government sought a consent decree from the Justice Department that gave the FDA greater control over the reopening.
“We didn’t have confidence that they would produce safe formula until we got control of the plant through a consent decree,” Mr. Califf said. “And a consent decree is a legal agreement involving the Department of Justice and the plant and the manufacturer that has to be negotiated.”
Mr. Calamari said the plant has infrequently been found to violate safety standards over the past decade and has worked to address the issues that the FDA wants to be addressed before the plant can reopen.
Cronobacter sakazakii is a naturally occurring bacteria, and no unopened can of the formula from the Sturgis plant was found to be contaminated with it.
Lawmakers told Mr. Calamari that Abbott should apologize to families for the plant closure and the formula shortage it has triggered.
“We’ve all heard about the inspections that were done and, quite frankly, it’s pretty disgusting,” said Rep. Jan Schakowsky, Illinois Democrat. “What we heard about the water on the floors and the water leaking from the ceiling and conditions that could lead to contamination, I don’t know how a company that has a reputation like yours, and a responsibility like yours, could actually get into a situation like that.”
Mr. Calamari said the plant has implemented broader testing requirements, replaced the factory floor and improved safety training for employees.
“We are very much aligned with the FDA on the standards and the process, steps, and what needs to be done in the facility, and we’re taking action on that right now,” Mr. Calamari said.