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FDA Prepares Major Announcement to Ease Baby Formula Shortage

2022-05-16T15:02:11.396Z


The plant investigated for contamination could reopen in 15 days, but the federal authorities are finalizing a decision that can remedy the shortage of products.


By Rebecca

Shabad

Health authorities will investigate why it took so long to send inspectors to Abbott's baby formula plant in Michigan, Food and Drug Administration (FDA) Commissioner Robert Califf said Monday during a interview on NBC News. 

The FDA received the first report in September of a sick infant whose infection was allegedly linked to infant formula produced at the Sturgis, Michigan, plant.

A detailed whistleblower report on alleged safety lapses at the plant was released in October, but the FDA didn't send inspectors to the facility until January, anchor Savannah Guthrie reported on NBC's

Today

show Monday .

[The partial paralysis of the plant has aggravated the shortage of baby formula in the United States since February, which is also due to other factors, according to experts, among which is the disruption in the supply chain due to the pandemic.]

What has happened with the possible contamination of baby formulas?, a doctor explains

March 4, 202203:41

When asked if the FDA took too long to respond, Califf said, “We always want to be as quick as possible while also being diligent, remembering, as this example shows, that if we don't shut down the plant [on time], then

we have a supply shortage

, so we have to get this right.”

[Is it advisable to dilute baby milk formula?

An expert gives advice in the face of scarcity]

In this sense, he anticipated that an attempt will be made to clarify what happened.

"There will be a full investigation of the facts over time, and we will do everything we can to correct any mistakes we made so that we don't repeat any mistakes in the future," he said. 

New measures in the face of scarcity

Califf said parents will hear an announcement from Abbott "very soon" about the way forward on the baby formula shortage, and suggested the company will announce plans

to reopen the plant within the next two weeks

.

"That's completely within the realm of possibility and, in fact, I think it's quite likely," he said.

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May 16, 202205:18

Califf rejected formula maker Perrigo 's prediction that the shortage will last until the end of the year , saying the FDA is taking a number of steps to increase production and

may also accept imported products

.

“Remember that formula destined for other countries may be labeled in a language that is not the language that is needed for mothers and other caregivers to mix the formula,” Califf said.

He added that the FDA has to test the formula to ensure it is safe and contains the correct ingredients.

"But I really hope that by the end of the day we will have an announcement about the way forward," she said.

[CVS, Walgreens and other pharmacies will limit the number of infant formulas per purchaser]

The Joe Biden administration has come under fire for formula shortages, which have worsened since the Abbott plant in Michigan closed in February.

The FDA investigated the facility after four babies who drank his formula developed bacterial infections and were hospitalized.

Infections may have contributed to the deaths of two of these babies, the agency said.

Abbott has said it conducted a thorough review and found "no evidence" linking its formula to disease.

Source: telemundo

All news articles on 2022-05-16

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