WASHINGTON (AP) — Federal plans to inspect a baby formula factory linked to the nationwide shortage were slowed by COVID-19, scheduling conflicts and other logistical problems, according to prepared testimony from the head of the Food and Drug Administration.
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FDA Commissioner Robert Califf is set to answer questions Wednesday from House lawmakers probing the events leading to the formula shortage, which has forced the U.S. to begin airlifting products from Europe while many parents still hunt for scarce supplies in stores.
The issue is largely tied to problems at Abbott Nutrition’s Michigan plant, the largest in the U.S., which the FDA shut down in February due to contamination. In prepared remarks, Califf gives the first detailed account of why it took his agency months to inspect the plant after first learning of potential problems last fall.
Members of an Energy and Commerce subcommittee will also hear from three infant formula makers, including a top executive from Abbott.
FDA staff began honing in on Abbott’s plant last year while tracking four bacterial infections in infants who had consumed formula from the facility. The cases occurred between September and January, causing four hospitalizations, including two deaths.
Califf will tell lawmakers that the FDA began planning to visit the Sturgis, Michigan, plant in early December, with inspectors set to arrive on Dec. 30. But Abbott said that about a dozen of its employees had recently tested positive for COVID-19 and requested a delay. As a result, the FDA didn’t begin its inspection until Jan. 31.
After detecting positive samples of bacteria in multiple parts of the plant, the FDA closed the facility and Abbott announced a massive recall of its formula on Feb. 17.
Abbott and the FDA have reached an agreement to reopen the plant next week, requiring the company to regularly undergo outside safety audits. But Califf’s testimony suggests FDA efforts to reopen the plant were slowed by negotiations with Abbott, which had to be codified in a court agreement.
“Because it was a negotiation process with a regulated firm, the U.S. government did not completely control the timeline,” states Califf’s written testimony.
The FDA has also faced questions about its timeline for reviewing an October whistleblower complaint alleging numerous safety violations at Abbott’s plant, including employees falsifying records and failing to test formula. Califf’s testimony details a two-month gap between when regulators received the report and when they actually interviewed the whistleblower.
Several FDA staffers reviewed the complaint in late October, but officials didn’t request an interview until early December. Because of conflicts with the whistleblower’s schedule, the interview didn’t take place until Dec. 22, according to the FDA testimony.
Senior FDA officials did not receive copies of the whistleblower complaint until February due to “an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the prepared remarks.
Califf is the only administration official who has testified thus far on the shortage, which has become a major political liability for President Joe Biden. Behind the shortage are other distinct factors, including supply disruptions caused by COVID-19 and industry consolidation that’s made the U.S. formula market vulnerable to disruption.
An Abbott executive is expected to tell the committee that his company will invest in additional capacity and supply chain safeguards to avoid future disruptions. After the company restarts production next month it will be able to produce more formula than before the recall, according to prepared remarks from Abbott’s senior vice president, Christopher Calamari.
The company will restate its contention that there is no direct link between its formula and the infant infections investigated by the FDA. Agency regulators have said the small number of cases and incomplete testing data make it hard to draw a direct connection between the illnesses and Abbott’s plant.
Executives from Reckitt and Gerber are also scheduled to testify.
Phineas, bottom line the FDA is too slow and incompetent. They never think thru consequences of draconian long term closures or actions (like killing millions of chickens) that cause disruptions.
Its all due to the monopoly that Abbott has on the market and the government policies from allowing other companies to exist. Time to open up the free market.
The FDA is quick to rush unnecessary and dangerous products to the market- covid vaccines for children to name one of many, as long as they profit big pharma. Don’t forget the FDA services big corporations they don’t work for u or me. Most of their funding comes from big pharma and big food
But when it comes to doing their job- like approving chemicals which are cancer causing and banned in many countries, those they approve to appease the big corporations that want to use them.
When it comes to making sure the food we eat is safe, they’re lax on the job, to the benefit of big corporations. apparently they knew about the problem and did nothing for months and blame “the mail” and “covid”. They’re a corrupt, inept, money hungry agency. They only got involved in the formula company when babies got sick and died and it became obvious to the public that the FDA had ignored complaints.
We have a few bridges for sale
Time to take away the FDA’s power. FDA should no longer be allowed to shut anything down; they can continue approving or disapproving, but non-approved things should be allowed to be sold with a warning.
hey phineas