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Abbott reaches agreement with FDA to resume formula production

WASHINGTON — Abbott Nutrition said Monday it had agreed to terms set by the Food and Drug Administration to resume operations at the company’s Michigan plant amid a national infant formula shortage.

The consent decree, which requires court approval, outlines the steps necessary to safely restart production and maintain the Sturgis site.

“Our number one priority is to provide infants and families with the high-quality formulas they need, and this is a major step towards reopening our Sturgis plant so that we can alleviate the shortage of formulas at the nationwide,” Abbott CEO Robert Ford said in a statement. “We look forward to working with the FDA to quickly and safely reopen the facility.”

Under the agreement, the Sturgis facility will be required to retain the services of an independent expert to review the transactions and ensure they comply with the law. The decree also provides for measures to test products and stop production in the event of contamination.

Once the FDA confirms that Abbott has met the initial requirements, the company could restart the site within two weeks. Abbott said it would take another six to eight weeks for the product to hit store shelves.

“Today’s action signifies that Abbott Nutrition has agreed to resolve certain issues identified by the agency at its infant formula manufacturing facility in Michigan,” FDA Commissioner Robert Califf said in a statement. a statement. “The public should be assured that the agency will do everything possible to continue to ensure that infant formulas and other proprietary products produced by the company meet FDA standards for safety and quality, which American consumers have come to expect and deserve.”

Later Monday, the Justice Department filed a lawsuit and proposed a consent decree to ensure the safety of the factory’s infant formula. According to a Department of Justice press release, the complaint alleges that the company operated its Michigan plant “under conditions and using practices inconsistent with regulations designed to ensure the quality and safety of infant formula, including including protection against the risk of contamination by bacteria”. .”

When reached for comment, an Abbott spokesperson referred NBC News to a previous statement from the company that denied any wrongdoing.

The Justice Department’s proposed consent decree would direct Abbott to tighten security measures and ensure compliance with federal laws and FDA guidelines for manufacturing.

“The actions we are announcing today will help to safely increase the supply of infant formula for families,” Attorney General Merrick Garland said in a statement.

The announcements came just hours after Califf said his agency would investigate why it had taken so long to send inspectors to the Michigan plant. A detailed report by a whistleblower on alleged safety breaches at the plant was released in October, but the FDA did not send inspectors to the facility until late October. January.

The FDA said during an inspection of Abbott’s facility that began Jan. 31, it observed “significant operational deficiencies” and found bacteria that can potentially trigger serious foodborne illness in Babies.

In an interview with Califf on NBC’s “Today” show on Monday, anchor Savannah Guthrie said the agency received the first report in September of a sick baby whose infection was linked to formula produced at the facility. ‘plant. When asked if the FDA was too slow to respond, Califf said, “We always want to be as quick as possible while being diligent, remembering, as this example shows, that if we don’t shut down the ‘factory, then we have a shortage of supply, so we have to do things right.’

He continued: “There will be a full investigation into the schedule, and we will do everything we can to correct any timing errors that we have had so that we don’t repeat any errors that may have been made.”

The Biden administration has come under fire for the formula shortage, which has worsened since the Abbott plant in Michigan closed in February. The FDA investigated the facility after four infants who drank its formula contracted bacterial infections and were hospitalized. The infections may also have contributed to the deaths of two babies, the agency said.

Abbott said they conducted a thorough review and found “no evidence” linking their baby formulas to illnesses.

The FDA also announced guidelines on “increased flexibilities” for importing on Monday. The revised guidelines would allow manufacturers who do not normally distribute infant formula in the United States to do so in order to increase availability.

“Companies seeking to take advantage of these flexibilities must submit information to the FDA to quickly assess whether the product is safe to use and provides adequate nutrition,” the agency said in a statement.

A senior administration official told reporters on a Monday night call that the FDA would prioritize reviewing applications that “have a good chance of succeeding” and are able to deliver the most formulas the most. as quickly as possible.

Countries that have “similar health and safety inspection systems to ours”, such as Australia, New Zealand and the UK, could soon provide a formula, said another senior official. administration.

A White House official said earlier Monday that the administration has been in contact with the four major infant formula makers “to identify transportation, logistical and supplier barriers to increased production of infant formula.” preparations in their FDA-approved facilities and the United States, to increase the amount and speed with which FDA-approved formula is shipped into the country, and ensure that formula moves quickly to retailers from the factories. “

The official also said the administration is talking with Amazon, Target and Walmart to identify areas of the country where supplies are extremely low and working with retailers and formula producers to bring the products to those areas.

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