The US is unlikely to be able prevent another baby formula shortage like the one last year that left parents across the country searching desperately for supplies, a former Food and Drug Administration official told House lawmakers.
(Bloomberg) — The US is unlikely to be able prevent another baby formula shortage like the one last year that left parents across the country searching desperately for supplies, a former Food and Drug Administration official told House lawmakers.
“The necessary safeguards have not been advanced at an adequate pace to prevent future illnesses,” Frank Yiannas, former deputy commissioner of FDA’s Office of Food Policy & Response, said Tuesday in a House oversight hearing. “The infant formula supply chain continues to lack serious resilience.”
The industry has been under scrutiny since Abbott Laboratories, the biggest maker of infant formula for the US market, withdrew products including bestselling Similac last year after reports of illness and deaths among a few babies who had consumed it. The recall left parents across the country scrambling to find supplies and forced the US to expand its sources of the products.
Read More: How a Deadly Pathogen Spread at Abbott’s Infant Formula Plant
Yiannas stepped down from the FDA in February after an outside review of the agency found that its food division needed a stronger leader capable of ironing out interdepartmental conflicts that have inhibited the agency’s ability to protect consumers.
Bacterial Contamination
In the hearing, lawmakers focused on areas where they said FDA oversight of the baby formula industry falls short. There is still no requirement for companies to report bacterial contamination found at manufacturing plants to the agency, Yiannas said. He presented lawmakers with a set of recommendations that include making Cronobacter sakazakii, which has been linked to babies’ illnesses, a nationally notifiable disease and demanding higher standards from formula manufacturers.
“I think the abundance of evidence suggests that Abbott was operating under very unsanitary conditions and likely was sporadically contaminating infant formula,” Yiannas testified.
Abbott has said there’s no evidence its products caused the illnesses and deaths and that closed formula containers at the homes of babies who were sickened didn’t contain bacteria. The company is facing separate probes over the shortage from the Federal Trade Commission, US Securities and Exchange Commission and Department of Justice.
The company’s commitment to the US formula market is “unmatched,” said Scott Stoffel, an Abbott spokesperson, in an email.
“We’re running our US facilities at increased capacity, we’re importing additional formula from Europe to help meet the country’s supply needs,” he said. “And we’re investing to build a new, $500 million state-of-the-art powdered infant formula plant in the US.”
Abbott shares closed 1.4% lower on Tuesday.
Read More: Abbott Reports Deeper Government Scrutiny Over Formula Shortage
The FDA only tests a fraction of formula supplies for bacteria, Yiannas said, making it easy for the agency to overlook potential contamination. “The probability of them finding contamination is virtually zero,” Yiannas said.
Perrigo Co., another top formula manufacturer, recently recalled some of its products in Canada due to potential bacterial contamination. An earlier recall from Reckitt Benckiser Group Plc also chipped away at supply as some Americans still struggle to find the products on shelves.
Market Consolidation
US lawmakers have been trying to maneuver around strict trade policies, constraints from government-welfare programs and intense FDA oversight to prevent a repeat of last year’s shortages.
Representative Katie Porter, the committee’s top Democrat, said Congress should hold big business accountable and focus on policy solutions for the baby formula industry. Just a handful of companies control most of the US baby formula market. Porter said she’s hoping to hear from other formula manufacturers about what they’ve taken away from the situation to prevent another from happening.
“In the end, with the concentration in the market, there was just no way to keep up,” said minority witness Peter Lurie, executive director of the Center for Science in the Public Interest.
Currently, Representative Rosa DeLauro of Connecticut is working with Senator Bob Casey of Pennsylvania on a bill that would diversify domestic manufacturing. Representative Becca Balint of Vermont said during the hearing Congress can do more to prevent price gouging in the formula industry.
The subcommittee is planning another meeting on infant formula on April 19.
FDA Actions
Earlier Tuesday, the FDA proposed an “immediate” strategy to ensure safe, adequate supplies of baby formula that were in nationwide shortage after reports of contamination led to recalls last year. The FDA is working to inspect all infant formula manufacturers at least annually, increase training for inspectors and improve communication with formula makers, according to a report.
“We witnessed last year how a safety concern at one facility could be the catalyst for a nationwide shortage,” FDA Commissioner Robert Califf said in a statement before the hearing. “That’s why we are looking to both strengthen and diversify the market, while also ensuring that manufacturers are producing infant formula under the safest conditions possible.”
(Updates shares and adds comments from Abbott spokesperson starting in eighth paragraph.)
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