x

Science

FDA Chief to Detail Delays Inspecting Baby Formula Plant

WASHINGTON — 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.

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.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

RELATED

LISBON, Portugal — The United Nations is hoping an international conference that got underway Monday will bring fresh momentum to protracted efforts for a global agreement on protecting the world's oceans.

Top Stories

General News

FALMOUTH, MA – The police in Falmouth have identified the victim in an accident involving a car plunging into the ocean on February 20, NBC10 Boston reported.

General News

NEW YORK – Meropi Kyriacou, the new Principal of The Cathedral School in Manhattan, was honored as The National Herald’s Educator of the Year.

General News

PHILADELPHIA – The Federation of Hellenic Societies of Philadelphia and Greater Delaware Valley announced that the Evzones, the Presidential Guard of Greece will be participating in the Philadelphia Greek Independence Day Parade on March 20.

Video

Mission…to Alonnisos, a TNH Documentary

O oceanic you sing and sail White on your body and yellow on your chimeneas For you're tired of the filthy waters of the harbors You who loved the distant Sporades You who lifted the tallest flags You who sail clear through the most dangerous caves Hail to you who let yourself be charmed by the sirens Hail to you for never having been afraid of the Symplegades (Andreas Empeirikos)   What traveler has not been fascinated by the Greek islands, drawn by the Sirens’ song of a traveler’s dreams? TNH and our video show ‘Mission’ marked the change of the season by transporting viewers into the heart of summer.

Enter your email address to subscribe

Provide your email address to subscribe. For e.g. abc@xyz.com

You may unsubscribe at any time using the link in our newsletter.