Amid infant formula fallout, FDA turns to agency veteran with little food experience

FDA Commissioner Robert Califf is trying to demonstrate his agency is taking the infant formula crisis seriously and address dysfunction in its food division by assigning his principal deputy to take a more commanding role on food issues. There’s just one problem: Food industry leaders, consumer advocates and state groups alike are outraged by the move

It’s an idea that makes sense on paper: Janet Woodcock is a respected veteran on the side of the agency tasked with overseeing drug approvals, and served as acting commissioner before Califf was confirmed. She’s also politically connected in Washington, and could raise the profile of food policy at the agency, which has long made regulating medical products its primary focus, relegating food to the back burner.

Food groups, however, say Woodcock is not the right choice for the role, citing her oversight record and lack of food policy experience. Specifically, she’s taken heat for the agency’s handling of opioids on her watch, one of the reasons she was President Joe Biden opted not to make her acting commissioner stint permanent.

"Appointing someone with a spotty consumer protection record on pharmaceutical products to oversee the food program is such a slap in the face,” said Brian Ronholm, director of food policy at Consumer Reports. “Food policy will continue to be a second class citizen at FDA unless there are significant structural changes."

As POLITICO recently reported, FDA’s foods division is rife with structural and leadership problems and has failed to act on several pressing nutrition and food safety issues. There’s also an open power struggle between the agency’s top two food officials, neither of which have clear authority. The way the agency is structured, no one person is in charge of food policy at the FDA, which oversees about 80 percent of the U.S. food supply.

Confusion and infighting has been so bad lately that one person close to the agency described it as an episode of the reality show “Survivor.”

Califf, who was confirmed as FDA commissioner in February, has thus far resisted a major shakeup of the food side of the agency.

“What I really want to avoid is what I've seen, which is: the new person comes in and feels like they have to change things just because,” Califf said in an interview last month. “Whatever we do, it's going to be thoughtful.”

It’s not clear how giving Woodcock a greater role overseeing food would address these problems.

According to an internal memo Califf sent to staff late Wednesday, Woodcock, who currently serves as principal deputy commissioner, will provide “strategic counsel and enterprise transformation support” to several key divisions at FDA, including the Center for Food Safety and Applied Nutrition, the dysfunctional foods division, which was the subject of POLITICO’s recent investigation. Other divisions include the Office of Regulatory Affairs, which handles all inspections across the agency, and the Office of Food Policy and Response, a small office that has little authority, and the Center for Veterinary Medicine, which oversees animal drugs and feed issues, among other things.

“I will continue to be involved in key decisions in these areas, and these Offices and Centers will still have a direct line reporting to me,” Califf said.

The early feedback from across the food policy world has been overwhelmingly negative.

“They’re not taking seriously the structural issues,” said one food industry insider, who has experience dealing with Washington and was granted anonymity to speak candidly. If Woodcock is essentially put in charge of foods, that would cement the impression that FDA sees the issue as unimportant, they said.

“It’s almost like status quo with an exclamation point,” the industry leader said. “You have a person with 30 years of experience, but not in food… Why is this a good move? This makes no sense.”

Another potential issue for Woodcock in this new role: She was one of seven officials who in October received the 34-page document from a whistleblower alleging serious food safety lapses in Abbott Nutrition’s Sturgis, Mich., plant, which has been at the center of the ongoing infant formula crisis.

The agency has not responded to questions about why those warnings did not spark more immediate action. The whistleblower was not interviewed until December. The FDA launched its inspection of the plant on Jan. 31, and announced the recall of formula made there on Feb. 17. Woodcock told POLITICO in April that her office is reviewing how the agency handled the incident.

One longtime FDA observer, not authorized to speak on the issue, argued that the Woodcock move makes sense at a time when FDA is struggling — and under intense public pressure over its handling of infant formula safety issues — because she is a “seasoned crisis manager, who is experience working with HHS, the White House, and Congress.”

“Right now, FDA needs to handle infant formula problems and figure out whether there are other smoking guns, at the same time there is a vacuum in food safety leadership,” the person said. “Right now, there isn’t time to straighten this out.”

And a former senior aide at FDA defended Woodcock’s record, saying that she was known for “efficiency and fairness” in her work at the Center for Drug Evaluation and Research and that it’s “unreasonable to say in 40 years of public service there should not be one questionable call. Show me a private sector executive with a record like that.”

The frustration with the lack of leadership on food at FDA has been brewing for years — and outside groups are now openly calling for a shakeup.

Last month, a broad coalition of food industry, consumer, health and state groups sent a letter to Califf urging a reorganization of the agency’s food program in response to POLITICO’s investigation. The letter was signed by groups like the Center for Science in the Public Interest, Environmental Working Group, Consumer Brands Association and American Frozen Food Institute — a mix of interests that don’t often work together. The groups said they were “troubled by the recent Politico reporting of serious problems in the FDA food program’s organizational structure, governance and performance.”

“Many throughout the consumer community and food industry have observed such problems and are concerned about their impact on the well-being of both consumers and industry,” they wrote. “All of us depend on the FDA to perform its regulatory role effectively, efficiently and transparently. And every American wants to have confidence in FDA’s ability to do that. We fear public confidence is in jeopardy.”

Steven Mandernach, who leads the Association of Food and Drug Officials, a group that represents state inspectors and others, publicly aired his frustration with the decentralized decision-making structure at the Food Safety Summit in Chicago last week.

“As I have had conversations across the food safety community, we were hearing a consistent theme: ‘We need an empowered, expert food safety leader at FDA with direct authority over the key components of the foods program,’” Mandernach said, according to prepared remarks.

Mandernach noted that food safety leaders have “great confidence” in Frank Yiannas, the deputy commissioner for food policy and response, but he doesn’t have the same authority that was granted former deputy commissioners for foods and veterinary medicine — a post that was eliminated in a Trump administration reorganization at the agency. Instead, Mandernach said, Yiannis “is a leader among equals,” on par with the director of the Center for Food Safety and Applied Nutrition, Susan Mayne, and the associate commissioner with regulatory affairs, which oversees all food and drug inspections. All three positions report directly to the FDA commissioner, a decentralized structure that “results in slow decision-making, limits coordination across the functional areas, and inconsistent approaches or silos which reduce effectiveness,” he said.