US baby formula shortage rages on

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peter pitts

Even as the government airlifts tons of formula in from other countries and Abbott reopens a factory that produces almost half the powdered formula sold in the United States, getting regular supply back to retailers could take weeks.

Former FDA Associate Commissioner Prof. Peter Pitts issued the following statement Tuesday on the baby formula shortage.

“The baby formula shortage is a shot across the bow of the FDA. The agency mustn’t allow the next headline to be ‘Who lost food safety?'”

Six potential proactive steps should include: 1.     Create a cross-center working group inside the FDA to collect and share best practices in avoiding and addressing shortages.2.     Identify products across the agency’s regulatory portfolio of products (such as baby formula, IV tubing, and sterile injectables) that have only a few large manufacturers.3.     Develop specific legislative requests for more robust authorities to demand information.4.     Reach out to relevant manufacturers for more regular communications on situations’ that might cause or heighten shortages.5.     Request funding for a CFSAN staff specifically tasked to address shortages and plans to mitigate and prevent them.6.     Recognize that part of solving the problem is early and robust communications with the relevant members of the specific professional and citizen constituencies.“Establish a cross-center communications team (coordinated directly by the Office of the Commissioner and including a dedicated liaison from the Department of Health and Human Services) dedicated to speedy and proactive measures when a shortage situation arises,” Pitts continued.

“That parents and pediatricians were caught equally unaware is inexcusable and should act as a hard lesson in the need for better, more 21st-century communications efforts. “Knowledge is power but knowledge, siloed and unshared is, at best a missed opportunity and at worse a deadly one. The drug shortage ecosystem relies on more than just legislatively – mandated notification requirements – it’s built on trust. Specifically, the FDA wants to work with manufacturers to solve the problem rather than simply whack them with 483s. And assume an “Après moi, le déluge” attitude.

“The baby formula shortage is a clarion call for the FDA to do better, much better – and to so right now.”

Peter Pitts discusses the Covid-19 vaccine on CNBC

FormulaGate is also a warning shot across the bow of the FDA relative to shortages for all of the other products it regulates across both its food and medical products portfolio. As a result, it’s time for the FDA to do a comprehensive audit of products whose manufacturing base is similarly consolidated.

The FDA must review all such consolidated products and develop a strategic plan should a major producer become unable to keep its plant open.

The President’s invocation of the Defense Production Act and Operation Fly Formula are meaningless political theater and an insult to American parents. There are no shortages in the ingredients that are used in baby formula. Not a single serving of baby formula has been delayed because of shortages.

President Biden says he is going to “send military aircraft to Europe” in order to bring baby formula into the US – but according to FDA Commissioner Califf, the FDA doesn’t even know where foreign baby formula might be coming from and, per Califf, it could even be from China.

To read more exclusive features and latest news please see our March-April issue here.

Media contact

Rebecca Morpeth Spayne,
Editor, International Trade Magazine
Tel: +44 (0) 1622 823 922

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