The troubled Michigan baby formula factory that shut down in February claims the Food and Drug Administration still hasn’t given them the green light to restart operations, despite the agency saying it could be back up and running in two weeks.
Abbott Laboratories revealed Monday that it had entered into a consent decree with the FDA that creates a pathway to reopen the facility, however the timeline for operations remains unclear.
‘After FDA approval, Abbott could restart the site within two weeks; from the time of restart it would take six to eight weeks before product is available on shelves,’ a company spokesperson told DailyMail.com on Monday.
The federal regulator, during a media call Monday night, confirmed it has not yet given its approval, saying: ‘We are negotiating with Abbott to get them up and running as soon as possible.’
The agency has declined to answer questions about the timeline for the Michigan’s plants reopening and instead directed reporters to Abbott.
‘I think we all know the treachery of giving exact timeframes to get these things done because as corrections are made sometimes new things are discovered and sometimes it goes very quickly,’ FDA Commissioner Robert Califf said.
‘Abbott itself has made a statement that they believe they could be started up within about two weeks and then up to full capacity in about two months, I think they said. You can refer back to them for details on this.’
Califf did add that he believes Abbott’s ‘timeframes are reasonable.’
Frank Yiannas, Deputy Commissioner for Food and Policy Response, weighed in to the conversation, offering another tiptoed response on timing.
‘When we went in to do the inspection at the time of the inspection, Abbott voluntarily ceased production and we issued our inspection report,’ he said. ‘Abbott has stated in the public domain that they have already been making adjustments and corrections to their facility and that’s the timeline they’re projecting – two weeks to be back up in operations and another six to eight weeks for their products to start hitting store shelves.
‘We think that’s totally reasonable and likely to happen.’
The FDA leaders also addressed the consent decree, which was filed on Monday in the U.S. District Court for the Western District of Michigan and is decree is still subject to court approval.
Califf said he doesn’t expect the FDA to delay Abbott’s reopening.
‘In terms of a consent decree, it does mandate that we approve every step but it is in real time, including independent consultants who are brought in to oversee the process,’ the commissioner explained. ‘I don’t expect delays on the FDAs part on this unless we see a problem that needs to be dealt with.
Yiannas stated the agency would review Abbott’s ‘corrective action plans’ and also echoed Califf’s response, saying: ‘We don’t believe the FDA will be a hindrance in getting them back up and running.’
Abbott told DailyMail.com on Monday the facility has been working on corrective actions since the FDA’s inspection earlier this year. The company claims it submitted its corrective action plan to the FDA on April 8.
‘Even before its formal response, Abbott had begun working to implement improvements and take corrective action,’ a spokesperson said. ‘Some of these actions included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating protocols regarding water, cleaning and maintenance procedures at the facility.
‘Abbott immediately implemented corrections to address the items that the FDA raised in its observations provided at the conclusion of the inspection. The company has also been making upgrades to the plant.’
Despite these actions, it still remains unclear when the agency will allow the agency to resume normal operations.
‘Once the FDA confirms the initial requirements for start-up have been met, Abbott could restart the site within two weeks,’ the manufacturer reiterated. ‘The company would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas. From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves.’
The proposed consent degree between Abbott and the FDA ‘obliges’ the baby formula manufacturer to ‘take actions that are expected to ultimately result in an increase of infant formula products, while ensuring that the company undertakes certain actions that would ensure safe powdered infant formula is produced at the facility.’
Once the court has approved the agreement, Abbott may restart operations, and the plant could be back in business in as few as two weeks – but products could take six to eight weeks from that point to reach supermarket shelves across the country.
Robert B. Ford, the CEO of Abbott, described the news as a ‘major step’ towards resuming production.
‘Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage,’ he said.
‘We look forward to working with the FDA to quickly and safely re-open the facility.
‘We know millions of parents and caregivers depend on us and we’re deeply sorry that our voluntary recall worsened the nationwide formula shortage.’
On Monday afternoon, Health and Human Services Secretary Xavier Becerra admitted to being aware of a coming shortage since last year. By August, the nationwide ‘out of stock’ level was already above 10 percent. It is now at 43 percent.
‘FDA has kept me apprised of this from last year,’ Becerra said on CNN. ‘We have been moving as quickly as we can.’
The formula shortage is the result of supply chain disruptions and workforce issues, but it was amplified by a safety recall of formulas made by Abbott and an ongoing shutdown of its manufacturing plant.
The factory closed down in February after two babies who drank formula produced at the facility – which makes the brands Similac, EleCare and Alimentum – died from bacterial infections.
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