FDA chief: Infant formula shortages could begin to ease within days

(The Hill) – The head of the Food and Drug Administration (FDA) told a House panel on Thursday that shortages of infant formula will start to ease within days. coming, but little is known about how the agency authorizes a manufacturing plant. safety issue to continue operating for months without stepping in.

FDA Commissioner Robert Califf was the first administration official to answer questions before Congress about the formula shortage, which has recently drawn the attention of lawmakers. Now facing pressure from frustrated families, those lawmakers have found no easy solution.

The scarcity is partly due to the closure of a manufacturing plant operated by Abbott Nutrition. The factory has been shut down since February, after four formula-fed infants were hospitalized with a rare bacterial infection.

The FDA earlier this week announced a preliminary consent agreement with Abbott to restart production, pending upgrades and safety certification.

“I’m pleased to say we’ve made very significant progress” on reopening the factory, Califf told members of House’s allocation subcommittee, “and I think we’re on the right track. aiming to get it up and running within the next week to two weeks, most likely by a two-week exit time. “

The combination of production increases from other manufacturers and the new authority on formula imports means that “we should see an improvement within a few days,” Califf said.

However, he admitted “it will be a few weeks before we get back to normal.”

Abbott said once production resumes, it will take six to eight weeks before the new formula hits store shelves.

Lawmakers told Califf why it took months to inspect the plant, even though agency officials have long known about the safety conditions. But Califf declined to comment on any details, citing an internal investigation.

The lack of disclosure does not sit well with legislators.

“This is what parents are asking us, they want to know what happened. It’s unacceptable to say you can’t comment on it,” said Representative Mark Pocan (D-Wis.) “Here’s a problem I’ve had with the FDA over and over again: You guys aren’t good at communicating.”

Califf’s appearance comes a day after the House approved $28 million in emergency funding for the agency to address supply concerns, and after the Biden administration announced new measures to boost supply, including invoking the Defense Production Act.

Califf said much of the agency’s problems stem from a lack of resources, most notably a lack of inspectors and outdated IT systems. If the excess money is misappropriated, he said the agency will use most of that money to hire more inspectors.

Republicans have turned the shortfall into a political blame game on the Biden administration, although members of both parties have expressed frustration at what they say is a lack of accountability from the FDA.

Headed in charge is Representative Rosa DeLauro (D-Conn.), Chairman of the Appropriations Committee. She pressed Califf for details about which officials viewed the whistleblower report sent to the agency in October and why no action was taken.

“You can’t hide behind an investigation, we need answers now,” DeLauro said.

The report from a former Abbott employee detailed serious safety violations, including falsifying records and releasing untested formula.

However, even before it was reported, the FDA knew that infants had become ill after drinking formula made at Abbott’s Michigan factory.

FDA staff did not interview the whistleblower until December, and the facility was not inspected until January.

“It all begs the question, why hasn’t the FDA taken action? Why did it take four months to pull this recipe off the shelf? ‘ said DeLauro.

“It makes me question which side the FDA is on. Are they on the side of Abbott, the industry, or on the side of American consumers, in this case babies, and their parents? ”

https://www.wfla.com/news/national/fda-chief-infant-formula-shortages-could-begin-to-ease-within-days/ FDA chief: Infant formula shortages could begin to ease within days

Alley Einstein

USTimesPost.com is an automatic aggregator of the all world’s media. In each content, the hyperlink to the primary source is specified. All trademarks belong to their rightful owners, all materials to their authors. If you are the owner of the content and do not want us to publish your materials, please contact us by email – admin@ustimespost.com. The content will be deleted within 24 hours.

Related Articles

Back to top button