Senator Collins Criticizes FDA’s Mishandling of Baby Formula Shortage
Click HERE to watch Sen. Collins’ Q&A on baby formula shortage.
Click HERE to watch Sen. Collins’ Q&A on FDA mailroom delays.
Washington, D.C. – At a Senate Health Committee hearing today on the Administration’s handling of the infant formula shortage, U.S. Senator Susan Collins questioned U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf about the agency’s response. She also criticized a months-long delay between FDA’s receipt of a whistleblower’s report and its review by senior officials, which had deadly consequences.
Senator Collins began by highlighting the desperation felt by families with infant children and expressed frustration at the lack of urgent action by the FDA to resolve this crisis.
Sen. Collins: “One family from Sidney, Maine, for example, contacted my office after the mother had been spending two months making a round trip of two hours just to get formula for her baby from her baby's pediatric specialist. That's just not sustainable. Why wasn't there better communication with parents right from the beginning? Why did it take so long for FDA to start being public about this very serious problem?”
Dr. Califf: “Well, I guess my best answer to that is that as we we’re monitoring the supply, up until about a month ago, there were issues but they were manageable for the vast majority of people. And then things turned to empty shelves very quickly. And that's when we really ramped up the public communication. There were concerns if there was a lot of public communication before that when things were manageable, that it would be understandable that families might purchase more than they needed to be safe, which as I've already said I'm not blaming them, that would be a normal response that we've seen in other areas with the pandemic.”
Sen. Collins: “I really think it would have been better if FDA had done what you said, which is put limits on how much could be purchased, but been more forthright with the parents who are really desperate.”
In February, a baby formula plant in Michigan was shut down after an FDA inspection found strains of deadly bacteria that sickened four infants, killing two. According to Dr. Califf’s testimony, the FDA received a whistleblower’s report on food safety issues at the plant last October, but it didn’t reach top FDA officials until February due to “mailroom issues.” Senator Collins asked Dr. Califf to explain how this extensive delay could have happened.
Sen. Collins: “You blamed COVID-19 staffing issues for preventing FDA leadership from receiving direct copies of the whistleblower report despite the fact that FDA's district office in Detroit received a hardcopy from a confidential informant way back on October 26th. Inexplicably, it took four months for that report to receive the attention and get to senior FDA leadership in mid-February… By that time, one infant had already died, two others were hospitalized, and the nationwide out of stock rate for infant formula had risen to 26 percent… What exactly do you mean by COVID staffing issues? Are you telling us that FDA still does not have people back to work in the mail room and other portions of your agency?”
Dr. Califf: “Let me be clear about two things. The first is the hard copies of the document didn't get to the leaders that should have gotten it for the reasons that you just gave. But there was a second issue, which is the escalation procedures, because the people on the staff did get it, and they were dealing with it. There was not a procedure in place for them to inform the leaders who should have seen it, neither the center director, nor the head of office policy and response, or head of ORA. I dealt with this in hospitals, in the quality systems, when nurses were not reporting surgeons’ errors, for example, we fixed it, and we've essentially had to do the same thing at the FDA. So I'm not blaming the mailroom, but there definitely are problems in the mailroom. This is not FDA staff, these are contractors hired by the FDA to handle the Federal Express.”
Senator Collins continued to press Dr. Califf on whether FDA and contract employees have returned to their offices. Dr. Califf was unable to provide a straightforward answer. This comes as the FDA is requesting additional funding for new full time employees in its Fiscal Year 2023 budget request.
Sen. Collins: “Are [the contractors] back to work at their offices in the mail rooms? I'm not talking about remote work. Are they back to work?
Dr. Califf: “For the jobs that require being on site, they're on site, like the mailroom being one example. Remember, our inspectors are distributed all around the country. They're mostly on the road. And our reviewers are reviewing documents using computers, so they're actually very efficient doing what they're doing.”
Sen. Collins: “But we need everybody to be back to where they would have been working pre-pandemic.”
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Last week, Congress passed and the president signed into law the Access to Baby Formula Act. The bipartisan legislation – which was co-sponsored by Senator Collins – will help alleviate the nationwide shortage of baby formula by requiring major formula manufacturers to develop action plans and provide FDA and USDA with flexibility that will help address disruptions.
Also last week, Senator Collins and a group of her colleagues sent a letter to Dr. Califf demanding answers on the FDA’s inadequate investigation into Abbott Nutrition’s Michigan manufacturing facility and failure to mitigate the nationwide baby formula shortage.
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