Key Takeaways from Senate HELP Hearing on FDA’s Role in Infant Formula Shortage

May 26, 2022

Today the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing grilling U.S. Food and Drug Commissioner Dr. Robert Califf over the agency’s handling of the ongoing infant formula shortage, which is impacting families across the nation.


Here are some of the key takeaways from the hearing:


#1: The FDA has blamed COVID-19 staffing shortages for senior officials’ failure to act on an October 2021 whistleblower complaint about the Abbott Sturgis facility, but the FDA also admitted there was not a proper reporting procedure in place.


In her questioning, Senator Susan Collins (R-ME) pressed Dr. Califf on press reports that senior FDA officials did not see the whistleblower report for months.


“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 26,” Senator Collins said. “Inexplicably, it took four months for that report to receive the attention and get to senior FDA leadership in mid-February… 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 mailing room and other portions of your agency? “


In his response, Dr. Califf stated, “Let me be clear about two things: the first is that the hardcopies 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. And so there was not a procedure in place for them to inform the leaders who should have seen it, either the Center Director nor the Head of the Office of Policy and Response nor the head of [the Office of Regulatory Affairs].”


#2: Despite blaming the FDA’s mistake on COVID-19 staffing issues, Dr. Califf could not answer what percentage of FDA employees have returned from remote work, but repeatedly defended the policy. 


Following Senator Collins’ questions, Senator Bill Cassidy (R-LA) detailed press reports of dysfunctional leadership within the FDA’s food division. “Zoom can work if people are actually communicating. But if there is a silence between the two, maybe actually being in the office and rubbing shoulders is somewhat conducive to information being passed,” Senator Cassidy said. “So I am gathering from your answer, that these two top leaders [in the food division] were probably Zooming, they were not in the office, and that their chief lieutenants were probably Zooming and they were not in the office… It does make sense to me that if you have a dysfunctional mailroom and a dysfunctional leadership, that it could take time for such a report to be done.”


#3: The FDA has not provided a clear answer on the status of its efforts to import infant formula from foreign countries or to approve new formula applications. 


Senator Roger Marshall (R-KS), questioned Dr. Califf on the Biden Administration’s plan to rectify the formal shortage in the short term.


“What has the FDA, what has the White House done to correct this problem?” Senator Marshall asked. “We’re kind of bragging about a shipment of I think about 78 million [pounds] of formula. Just to put some numbers to that, that’s probably enough formula to feed the babies of Kansas for three or four days.”


Ranking Member Senator Richard Burr (R-NC) pressed Dr. Califf on the percentage of new formula submissions the agency had approved – a question that remains unanswered.


“Complacency is apparently the FDA’s catch phrase when it comes to infant formula,” Senator Burr said. “In FY21, the FDA received 42 submissions for new infant formulas. The agency was able to review only 15 of those submissions within 90 days – that’s one-third. What happened to the other submissions? Did you expedite the review of the new formula submissions when you took the helm at the FDA amidst the growing shortage?”


#4: The infant formula shortage does not reflect a lack of funding, but a lack of prioritization at the FDA.


Senator Burr also pressed Dr. Califf on the resources and priorities of the FDA’s food center.


“Dr. Califf, I’ve looked at initial review of some of the activities of the food center and I’m concerned with your prioritization of the activities with the staff you have,” Senator Burr said. “Since the voluntary recall for infant formula, the FDA food center has spent time making changes to the definition of yogurt, opining on color additives in Antarctic krill meal – that’s fish food – so that farm raised salmon looks more pink, and making announcements about the use of the definition ‘healthy.’ Since the first infant hospitalization, the same center has issued a rule on the definition of ‘French Dressing,’ and issued guidance on cheese and chocolates that stray from the FDA’s official definitions.


“This is a pattern. Over the last decade, the same center has gone after salt, sprinkles, and even the definition of frozen cherry pie.”


Concluding his questioning, Senator Burr said, “I hope that the Chair’s request did not fall on deaf ears that a detailed, comprehensive plan should be something that you could produce now, if, in fact, the agency is working at the expedited pace that you addressed.”