Califf uses budget hearing to advocate for resources, authority to monitor supply chains

Regulatory NewsRegulatory News | 19 May 2022 |  By 

A House appropriations subcommittee hearing on the proposed budget for the US Food and Drug Administration placed the agency’s commissioner, Robert M. Califf, on the hot seat, taking criticism for failing to prevent an infant formula shortage in the country. In turn, Califf used the opportunity to ask lawmakers for more resources and authority to oversee the supply chains for products the FDA regulates.
Califf testified virtually on 19 May before the House Appropriations agriculture subcommittee on the Biden administration’s $8.4 billion FDA budget request. He was immediately scorched by lawmakers over the current infant formula shortage that was caused by a recall after formula from an Abbott manufacturing facility in Sturgis, MI, is thought to have been linked to two infant deaths.
Califf noted that 3.5 million children are born every year in the US, yet the FDA Center for Food Safety and Applied Nutrition (CFSAN) only has funding for 13 staff members who are tasked with ensuring safety and adequate nutrition of infant formula. He also noted that the agency has no authority or dedicated resources to monitor and respond to supply chain disruptions in this area.
“This crisis has shown us the impact of having a single manufacturer cease production for a brief period, and unless we strengthen the resiliency of our supply chain, we could be one natural disaster, quality mishap, or cyber attack from being here again,” the commissioner warned.
“When we review the infant formula situation, we will find specific issues where we could have could have done better, and we will of course take accountability for any shortcomings,” he added. “But unless we make the right investments in our infrastructure including technology, data, people and a modernized supply chain system, we will continue to see shortages and problems across the industries we regulate."
House Appropriations Chair Rep. Rosa DeLauro (D-CT) argued that in her view, the bigger issue  is that the FDA does not prioritize food safety in the way it prioritizes other regulated products and argues the agency needs restructuring in order to change that.
“This issue goes beyond funding and that has to do with a structural problem,” said DeLauro. “At another time, I would like to discuss the need for a deputy commissioner for foods with accountability to the commissioner who has direct line authority over (CFSAN), the Center for Veterinary Medicine, and food-related components and operations at the Office of Regulatory Affairs.”
“This should happen immediately and the person who is appointed needs to have relevant and appropriate food credentials," she added.
DeLauro also raised the issue of a whistleblower report, first reported in Politico, that warned the FDA about shortcomings in the agency’s oversight of infant formula safety. She asked Califf what the most concerning issue for him in that report was.
Califf said the most concerning issue for him is that it states that the FDA’s integrity in general to oversee food safety has been compromised.
"Once integrity is compromised, the question then is how can you trust any of the systems that are in place,” he added.
DeLauro noted that while the whistleblower report was submitted to the FDA in October 2021, it wasn’t until February 2022 that the agency started to take action. That delay, according to DeLauro, was a “dereliction of duty” that goes all the way up to the acting commissioner at the time, Janet Woodcock.
"I understand that you need resources and I've worked to increase resources to the FDA but … you have serious structural leadership issues,” she said. “Someone in this agency needs to have serious relevant food credentials … otherwise food safety will continue to be a second-class citizen at the FDA."
DeLauro pushed Califf to provide more information on who at the FDA received the whistleblower report and failed to act on it. Califf, however, declined to give additional details arguing the agency’s investigation is still ongoing and he would be able to provide more information during a House Oversight committee meeting on the topic scheduled for 25 May.
DeLauro noted that in 2014 the FDA tried to introduce a rule that would increase bacteria safety testing standards by requiring more regular infant formula manufacturing facility inspections by the FDA. The measure ultimately failed, and she laid the blame on lobbying from Abbott and other formula makers. Considering the recent crisis, she asked if the FDA had any plans to increase inspections.
Califf said the FDA is now conducting daily inspections at the Sturgis, MI, plant and plans to bolster more “orderly inspections” at other facilities and would get back to the committee with further details.
The commissioner also took the opportunity during the hearing to talk about the FDA’s need to have access to supply chain data that many in regulated industries have argued is too administratively burdensome not just for manufacturers but also for regulators. [Related: Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome, Regulatory Focus, 20 April, 2022]
“The sales [of infant formula] are actually higher than they were, people are buying more formula now than before the recall so we have a problem of distribution,” he said. “The FDA has no access right now into the supply chain data from the companies that manufacture and sell the formula, so a good bit of my week this week was getting on the phone with CEOs... to try to get the right product to the right place in an organized way.”
“We're requesting again that we have more authority to look at the supply chains, much like the banks did years ago so that we can test and preempt these kinds of problems rather than having to react to them,” he added.
DeLauro seemed to agree with Califf that the FDA needs such authorities and more. She noted the FDA also needs authority to initiate mandatory recalls.
"You ought to be up here demanding that we provide you with that kind of authority to get the information that you need in order to do your job as a regulatory agency," she said.
Agriculture subcommittee Chair Rep. Sanford Bishop (D-GA) said he was worried that FDA’s offices with oversight of infant formula were so short-staffed and was worried about all the other offices with staffing shortages because the public only hears about them during a crisis.
“I would say the entire food side of the FDA is understaffed in every category,” Califf responded. “That’s why in the budget we've asked to staff up and to improve the authorization for hiring and salaries, just like we have on the medical products side.”
He went on to say he doesn’t disagree with members of Congress who have said that more funding alone won’t fix things at the FDA but noted under current federal hiring authorities it takes months to bring someone on board at the agency for food safety.
“We don't see that with the hiring authority we got with the 21st Century Cures [Act] on the drug and device side,” said Califf. “I really want to implore you to help us get staffed up and I take seriously... [that] money and people alone won't solve the problem. We also have to have leadership and structure.”
Agriculture subcommittee ranking member Rep. Andy Harris (R-MD) said the pandemic has highlighted the lack of domestic manufacturing of pharmaceuticals and active pharmaceutical ingredients (API) and asked how the budget request would aid in that area.
Califf said domestic manufacturing is a big topic which he plans to write about later but noted that the infant formula crisis is happening in the face of complete domestic production. He also noted on the other hand, there has been a shortage of contrast media for angiograms because one of the major producers couldn’t bring in their products from Shanghai, China, due to the pandemic.
"What we need is a versatile supply chain built on a digital backbone so that we can keep track of where the products are and to stress test that supply chain,” Califf said. “The answer isn't just onshoring, the answer is having a diversified system that we can have to prevent shortages occurring preemptively instead of waiting for them to happen.”
During the hearing, Bishop also noted that over the past few years Congress has increased funding for the FDA to do unannounced foreign drug inspections, and the agency’s practice of announcing foreign drug facilities weeks before they happen raises questions of parity with domestic inspections. He asked Califf for a commitment that the FDA will restart unannounced inspections of foreign drug facilities.
Califf noted that the agency has already started unannounced inspections in India and China will follow shortly behind but because of the COVID-19 pandemic it's been difficult to do inspections in there.
Overall, Califf is asking for $8.4 billion for FY2023, which Harris noted was a 25% bump from FY2022 enacted levels.
“I recognize that $1.6 billion in mandatory funding is requested to support FDA's part of the administration's pandemic preparedness plan,” he said. “But setting that aside, FDA is still seeking an overall increase of $509 million, more than half a billion dollars over FY2022, with $153 million coming from new user fees.”
Harris said he understands the FDA does important work but argued the size of the budget request “does not acknowledge the economic reality that our nation faces.”
“In times like these, as stewards of taxpayer dollars we must make tough decisions in the greater interest of the American people,” he added. “Growing the size of federal programs and government workers is generally not in the best interest of our nation's economy and future. Further, I believe many of the problems facing your agency can be solved through strong leadership rather than more money.”


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