Top House Democrats Set to Grill FDA Chief in Formula Plant Plan

ryanniesMay 19, 2022

Bloomberg News

Anna Edoni

(Bloomberg) —Major Democrats plan to grill the head of the Food and Drug Administration on plans to reopen Abbott Laboratories’ infant formula without first addressing whistleblower allegations. ..

Rosa De Lauro, chairman of House Applications, said he would like to know why FDA Commissioner Robert Califf has signed an agreement to allow prescription production to resume at Abbott’s plant in Sturgis, Michigan. Abbott has faced a fallout due to illness in four babies who have been given infant formula for the past few months, but De Lauro has revoked the previous quality of whistleblowers at the company’s factory. I am concerned that the agency has not addressed the reporting of counterfeit records.

“They lied,” Connecticut Democrat De Lauro said in an interview Wednesday. “They sold a deliberately contaminated product. I want to know why the FDA considers it safe enough to resume.”

Abbott is still considering whistleblower reports in a statement, saying a former employee was “dismissed for a serious breach of Abbott’s food safety policy.”

“We empower our employees to identify and report issues that could compromise the safety and quality of our products, which takes precedence over other considerations,” the company said. increase.

At a hearing on Thursday, De Lauro will have the opportunity to ask the Caliph about the gist of a national shortage of infant formula that has shaken both parents and Congress. A milk maker says the pandemic has disrupted the supply chain, but shortages are at stake as the Abbott factory closes during a major recall earlier this year, and President Joe Biden’s defense production on Wednesday. Invoked the law to increase supply.

The upcoming hearing of the Caliph focuses on the FDA’s 2023 budget request. His opening statement on the Commission’s website mentions infant formula only once.

Under scrutiny

Abbott is being scrutinized because four babies who consumed factory-produced milk powder were infected with Cronobacter, two of whom died and were recalled. The FDA said it stopped investigating reports of product-related illnesses without providing the information it found.

Abbott states that there is no conclusive evidence to associate the product with an infectious disease and that analysis of bacterial strains in sick infants is inconsistent with that found in the plant.

A whistleblower, an anonymous former Abbott employee, prevented factory workers from finding evidence of batches of formula that were tested positive for microorganisms by FDA staff during a 2019 inspection. Insisted. According to the report, Abbott workers destroyed parts of the batch without testing the rest before distribution.

A former employee explained the culture of favoritism in the factory, which was blinded to many issues, including the ongoing problem with the seams of cans of infant formula. According to the report, powdered milk could appear at the seams of factory cans. In other words, it was not tightly sealed and could allow moisture and bacteria to enter.

Recently, the agency did not send inspectors to Abbott’s factory until the end of January, after which it was created there in February, five months after the agency was warned about the first case of a sick baby. Recalled powdered milk. DeLauro asked the Department of Health and Human Services inspector general to investigate the FDA’s response to the situation.

Whistleblowers filed a report with FDA authorities in October. At that time, the agency received at least one report of a sick baby from Cronobacter after being fed powdered milk from Abbott’s plants. FDA officials did not interview whistleblowers until December, De Lauro said.

September inspection

DeLauro released a report shortly after receiving it last month. She said her agency did not give her the latest information on whether a decision was made on her allegations.

Comment on the assessment of the allegations as it is part of the FDA’s commitment to assess policies for illnesses and recalls related to infant formula after the imminent supply crisis has been resolved. Rejected, the spokeswoman said.

Caliphs may also face questions about regular FDA inspections at the Michigan plant, which began on September 20th. On the same day, Minnesota officials reported to the authorities the first infant infected with Cronobacter. According to a detailed test report obtained by Bloomberg, inspectors record five cases of positive Cronobacter testing in environmental non-food samples from factories from January 2019 to August 2021. discovered.

They also reported that Abbott discovered Cronobacter in infant formulas completed in 2019 and 2020. The September discovery of Cronobacter was not included in the FDA’s publicly published test summary.

The Centers for Disease Control and Prevention completed an official investigation of four cases and Abbott on May 12, stating that no further infections had occurred. Caliph said Monday that it was too early to determine if there was a link between the product and the disease.

“There are many factors involved in this study and we are not yet in a position to make a definitive statement,” he said. The FDA said on April 1 that it has set up an incident management group to address supply chain and food safety issues.

Enhanced monitoring

Having reached an agreement with the United States on Monday, with FDA approval, Abbott will be able to resume prescribing in Michigan under increased scrutiny. The company then plans to reopen the factory in two weeks, saying it will take six to eight weeks for the milk to be made on the store shelves.

De Lauro said she was confident that she wasn’t the only one asking the FDA’s head for officially related questions.

Caliph will also meet with a member of the House Energy and Commerce Commission’s Oversight Panel on May 25 to investigate the slow response of the FDA. Abbott executives will testify in front of the panel on the same day, as will executives at Reckitt Benkeiser Group PLC and Nestlé SA, two other major infant formula suppliers in the United States.

Bloomberg.com