WASHINGTON—Lawmakers said at a congressional hearing Tuesday that they will dig deeper into the infant formula industry and U.S. Food and Drug Administration oversight of industry, following testimony from a former FDA official about the continued vulnerability of the formula market.
“The country still has an outbreak, tornado, flood, or cyberattack to keep from falling into the same predicament as today,” said Frank Yiannas, former FDA deputy commissioner for food policy and response. February 17, 2022”. a hearing of the House Oversight Committee’s healthcare panel. Mr. Yiannas helped lead the agency’s response to recipe recall and the resulting shortage.
In February 2022,
closed its largest formula factory in Sturgis, Mich., after the FDA received a series of complaints about four infants becoming ill—including two deaths—from a rare bacterial infection from cronobacter after consuming formula produced at this facility.
An internal FDA review published last September found a “confluence of systemic vulnerabilities” ranging from outdated information technology to limited training among FDA inspectors. impede the agency’s response.
Representative Lisa McClain (R., Mich.), chair of the panel, said she invited FDA officials to testify on April 19.
“Unlike Abbott, the FDA is not responsible,” McClain said, citing the agency’s decision to delay some inspections because of the pandemic and the agency’s failure to take into account the impact of home closures. Sturgis machine for the formula market. The FDA has requested additional authority to require manufacturers to share information with the agency that can help them anticipate any supply disruptions.
The FDA did not immediately respond to a request for comment.
The panel’s top Democrat, Representative Katie Porter of California, told reporters she and McClain were also discussing inviting Abbott and other industry officials to appear before the panel.
“It’s good to get feedback from the manufacturers here—not just Abbott. We know what they did and it was wrong, but what lesson are other manufacturers learning so we don’t have the next Abbott?” she speaks.
Abbott spokesman John Koval said on Tuesday, “at Abbott, the quality and safety of our products is always a top priority.” He added that the company doesn’t think the four infant illnesses were caused by contamination at their factory, noting that “none of the delivered, sealed products” tested positive for cronobacter.
In a rare turn of events on Capitol Hill, legislators on both sides raised many of the same concerns, sometimes citing their own experiences when parents sought out formula.
“After my son was born [last August]I actually faced a situation where I had to go from store to store and the shelves were empty,” said Representative Jimmy Gomez (D., Calif.)
Mr. Yiannas, who left the FDA in February 2023, said the agency’s poor internal communication prevented a quicker response. Although at the end of October 2021, a whistleblower filed a detailed complaint outlining steps Abbott took to allegedly falsify records and mislead regulators, officials The FDA did not interview the person until the end of December. It then concluded that the complaint was “too vague” and did not require follow-up, Mr. Yiannas said in his testimony.
The FDA began a formal inspection of the Sturgis plant in late January, where inspectors found evidence of cronobacter bacteria in the facility, but Yiannas said he wasn’t aware of these events until early this month. 2 year 2022.
“I believe that if we had reacted earlier, we could have limited or minimized this to such a catastrophic level,” he told lawmakers on Tuesday.
A timeline provided by the FDA states that the whistleblower delayed a meeting with the agency for several weeks due to scheduling issues, and the information provided then helped inform the January review. .
Mr. Yiannas also noted that FDA inspectors that conducted the previous Abbott plant review in September 2021 were unaware that the agency had received a report of an infant illness on the day the inspection began. head, which may prompt them to take a closer look.
Attorneys with the consumer protection arm of the Department of Justice are conducting a criminal investigation of conduct at the Abbott factory leading to the closure, The Wall Street Journal reported. The company also said the Securities and Exchange Commission and the Federal Trade Commission were investigating its baby formula business. Abbott said it was cooperating with investigations.
In response to earlier criticism of the agency’s handling of infant formula shortages, FDA Commissioner Robert Califf issued a statement. recommend an agency overhaul strengthen and streamline the leadership of the food department. FDA officials have said the restructuring will boost communication within the agency, though they also expressed concerns that the infant formula industry is highly consolidated still dependent on a few factories, many with old equipment.
Artwork: Laura Kammermann
The agency also sent a letter to formula manufacturers earlier this month, urging them to review safety procedures after observing some problematic practices during visits to manufacturers. production machines involved in cleaning and monitoring bacteria.
Last week, Perrigo Recovery company shipment of Gerber brand baby milk powder because of the possible presence of cronobacter, although the company said no product distributed tested positive for the presence of this bacteria.
FDA says it will support add bacteria to the list of cases that physicians and laboratories must report to public health authorities. Currently, only two US states, Minnesota and Michigan, require that cases of cronobacter bacteria be reported to state public health authorities. As a result, scientists also have less genetic information about cronobacter cases than other bacteria. That can make it harder to identify and prevent an outbreak.
Both Mr. Yiannas and Peter Lurie, president of the Center for Science in the Public Interest, who also testified on Tuesday, urged the Council of State and Territory Epidemiologists to add cronobacter infections to the list. list of cases to report. The group meets annually and is expected to gather at the end of June.
Mr. Yiannas also called on lawmakers to strengthen legal requirements for infant formula manufacturers and asked companies to set higher standards, including existing facilities and equipment. greater.
As part of the Biden administration’s recent budget proposal, the FDA asked lawmakers to expand its authority to require formula manufacturers to notify the agency if their final product has negative results. test positive for certain pathogens, conduct more surveillance of their facilities, and let FDA know of any supply problems under certain circumstances.
Write to Kristina Peterson at [email protected]
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