The Food and Drug Administration needs to overhaul its structure so that a single person is clearly in charge of its food programs, an independent panel said in a report
WASHINGTON—The Food and Drug Administration needs to overhaul its structure so that a single person is clearly in charge of its food programs, an independent panel said in a report released Tuesday. The report from the Reagan-Udall Foundation for the FDA, a nonprofit created by Congress and funded largely by the FDA, also recommended that the agency boost the visibility of its food programs and create a new center focused on nutrition to elevate its role.
nationwide shortages of baby formulaMuch of the report, prepared after a review by a panel of former government officials and food-safety and public-health experts, focused on ways to create a more straightforward leadership structure at the FDA. “The lack of a single clearly identified person to lead the Human Foods Program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil,” the report said. Mr. Califf said in a statement Tuesday that the FDA would provide details of a new vision and structure for the FDA’s food programs in public comments by the end of January. Currently, two top officials with overlapping jurisdictions both report to Mr. Califf: Susan Mayne, director of the Center for Food Safety and Applied Nutrition, which sets food standards and drafts many regulations; and Frank Yiannas, deputy commissioner of the Office of Food Policy and Response, which responds to outbreaks and recalls, among other responsibilities. In addition, a separate arm manages the FDA’s inspectors. The existing structure creates problems by discouraging FDA employees from sharing information or collaborating with each other, a particular problem during crises including the recent baby-formula shortage, according to the report. The FDA could improve its operations either by establishing a separate Federal Food Administration, split off from a Federal Drug Administration, within the Department of Health and Human Services, or by reorganizing the lines of command within the FDA, the panel suggested, giving several different options. “The lesson of the Titanic is you need someone in the pilot house looking out for icebergs. Every one of these options would put a single person in charge of food safety,” said Scott Faber, senior vice president of government affairs at the Environmental Working Group, a nonprofit focused on public health and the environment.Photo:The Consumer Brands Association would oppose the creation of a new food agency because it would take too long to confirm a new political appointee, said Roberta Wagner, the group’s vice president of regulatory and technical affairs. She said the group, which represents food and beverage companies, would prefer to see a deputy commissioner of food programs within the FDA. Michael Taylor, a former deputy commissioner for foods and veterinary medicine at the FDA and a current board member of Stop Foodborne Illness, a public-health nonprofit, applauded the report for documenting myriad problems within the FDA’s food program and urging structural changes. “If you boil it down, the status quo has been blown out of the water and that’s good,” Mr. Taylor said. “The question is how do you follow through and make the change.” The report said the FDA is also hamstrung by a defensive, risk-averse internal culture, noting its employees at times appeared reluctant to take action “unless they feel that, with certainty, the action could withstand legal challenges.”problems at a major baby-formula plant that exacerbated existing shortages and left parents scouring stores for supplies. The agency also has been faced this year with illness outbreaks tied to peanut butter and ice cream, among other foods, that have sickened hundreds of people. About 48 million Americans, or one in six people, get sick from foodborne diseases each year, sending about 128,000 to the hospital and killing around 3,000 people, according to data from the Centers for Disease Control and Prevention.How should the FDA improve its food regulation programs? Join the conversation below. The independent review also found that the FDA hasn’t been able to shift its focus to preventing food-borne outbreaks before they occur and instead has been reacting once they have. Lawmakers had hoped to change the agency’s operating mode when they passed the Food Safety Modernization Act in late 2010, the biggest overhaul of federal food-safety regulations in 70 years. The seven major rules that make up the law established new requirements for food manufacturers, importers, farmers and others, and gave the FDA new powers, including holding companies responsible for keeping plants clean and reducing the risk of pathogens such as salmonella andBut 12 years after the bill’s passage, the FDA is still completing rules around ensuring that the water used to grow fruits and vegetables is safe after the food industry objected toFoodborne illness outbreaks have continued in recent years, tied to foods from leafy greens to ground beef and melon.have roiled the produce industry, for example, resulting in deaths and millions of dollars in losses for growers, retailers and restaurants. Tuesday’s report also recommended that the FDA boost the prominence of its activities related to nutrition, saying that the agency has a significant role in helping to prevent diet-related diseases and encourage healthier eating. The report urged the creation of a new Center for Nutrition with its own funding and leadership, regardless of what other changes are made at the FDA. “The devil will be in the details of how they would manage that,” said Donna Garren, executive vice president at the American Frozen Food Institute. She said her group wouldn’t be opposed to a center on nutrition, but cautioned that “setting up a new agency is not an easy process and it will cause some disruptions.” While both Democrats and Republicans are broadly supportive of improving Americans’ diets, Republicans have balked at some steps that would restrict choices offered to consumers or, in some instances, school children eating lunch.Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
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