FDA Chief Califf: Agency Likely to OK Abbott's Baby Formula Plant Reopening

Food and Drug Administration Commissioner Dr. Robert Califf said on Monday the agency is likely to approve the reopening of Abbott Laboratory's baby formula manufacturing facility in Sturgis, Michigan, in two weeks after ensuring that the product is safe and any problems have been rectified.

"We have an obligation to watch to make sure the problems have been rectified and the formula will be safe, remembering that normal formula has over 30 constituents that must be there as a substitute for breast milk," Califf told NBC "Today" anchor Savannah Guthrie. "Very soon, you should hear an announcement about moving forward, and of course, Abbott is responsible with the timeline but I'm very comfortable with what they said about two weeks … [it's] entirely within the realm of possibility, and I think quite likely."

Abbott closed its Sturgis facility earlier this year after complaints surfaced of infants becoming ill with bacterial contamination. The company says its plants are "not likely the source of infection," after the FDA cited five separate cases of illness in babies that were given the company's formula, with two of the babies dying.

Califf also said he disagrees with comments made by Murray Kessler, chief executive of Perrigo Company PLC, which makes store-brand baby formulas for retailers, including Walmart Inc. and Amazon.com, Inc., who said over the weekend he expects shortages and high demand to continue for the rest of the year.

"We don't expect it to last to the end of the year," Califf said Monday. "We're taking a number of measures, including getting all the manufacturers to step up, getting the Sturgis plant up and going, also importing or bringing [in] product that was intended for other countries. That is well underway now and in fact, I expect by the end of the day today, we're likely to have an announcement about that path forward."

He added that as a grandparent of six, including a baby, he knows it is essential to get red tape lifted to allow extra formula to be brought into the United States quickly from other countries, but "we also have to be safe."

"Remember that formula intended for other countries may be labeled in a language that is not the language needed for instructions for mothers and other caretakers to mix up the formula," Califf said. "We also have to make sure that we're testing the formula, and that it is safe and has the right constituents. But I really expect by the end of the day we'll have an announcement on that path forward."

Califf also addressed the timeline between when the FDA first got reports of an ill baby, back in September, while not sending inspectors to the Abbott facility until January, even though there was documentation about the plant as early as October.

"We always want to be as fast as we can possibly be while also being diligent, remembering as shown by this example that if we do close a plant, then we have a supply shortage, so we have to get this right," he said. "Having said that, there will be a full investigation of the timeline, and we'll do everything possible to direct any errors in timing that we had so that we don't repeat any mistakes that may have been made."

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