FDA assesses oversight changes after formula, Juul issues

WASHINGTON (AP) — The head of the Food and Drug Administration has called for a review of the agency’s food and tobacco control programs after months of criticism of their handling of infant formula shortages and reviews of e-cigarettes.

Tuesday’s announcement comes as FDA Commissioner Robert Califf tries to brush off several controversies that have dominated his second term as the agency’s head, including the belated response to contamination concerns at the company’s largest plant. country infant formula.

“Fundamental questions about structure, function, funding and leadership must be addressed” in the agency’s food program, Califf said in a statement. The agency’s Tobacco Centre, which regulates traditional cigarettes and vaping products, faces policy and enforcement issues related to “a growing number of new products that may have significant health consequences public,” he said.

Califf said the Reagan-Udall Foundation — a nongovernmental research group created by Congress to support the FDA’s work — would convene experts to provide assessments within 60 business days of food and tobacco operations. Experts should consult FDA staff as well as outside groups to gather a wide range of opinions. Califf and his team have already begun meeting with outside stakeholders, the FDA noted.

The announcement of the review comes a day before Califf is scheduled to testify before the Senate Agriculture Committee about the FDA’s food safety oversight.

More than two dozen consumer groups have called on Califf to appoint an official to oversee all FDA food operations, which are scattered across several centers responsible for nutritional standards, factory inspections and animal feed. But Califf told The Associated Press in an interview that he believes more fundamental changes are needed.

“I don’t think structure alone is really the answer, or leadership alone is the answer,” Califf said. “There’s an ongoing concern that we really need to correct the fundamentals, which includes all of those things.”

Califf said he agreed with criticism that the food program has been underfunded compared to the FDA’s drug program, which receives more than $1 billion a year in user fees from industry. The agency recently requested more food funding and authority to help track supply chains to prevent future shortages.

Parents and politicians have also expressed frustration with the agency’s handling of a recent decision to ban all e-cigarettes from Juul, the American leader in vaping. A federal court quickly blocked the agency’s order. The FDA then backtracked in court, saying he needed more time to consider Juul’s claim because of its “unique scientific issues.”

The FDA has also struggled to review millions of other applications from vaping companies, resulting in several missed regulatory deadlines over the past two years.

Califf again cited funding issues, pointing out that the FDA cannot collect user fees from vaping companies that submit their products. The agency has asked Congress for this authority.

“I don’t think anyone anticipated that there would be 6.7 million vaping product applications coming in during a pandemic that was stressing the entire agency,” Califf said.

Last week, the FDA announced it would miss another deadline to remove thousands of illegal e-cigarettes that use synthetic nicotine.. FDA officials specifically asked Congress to give the agency authority over these products, which had used a legal loophole to circumvent regulations.

Sen. Dick Durbin, a Democrat from Illinois, has suggested that Califf resign if the agency cannot quickly remove these products.

President Joe Biden appealed to Califf for the job at the FDA largely because of his previous experience at the agency, which he briefly led during the Obama administration. A respected cardiologist and researcher, Califf planned to focus his time at the FDA on combating medical misinformation and streamlining the agency’s data systems.

But those efforts have been overshadowed by new controversies, including political outrage over formula shortages.that forced the United States to airlift millions of containers of infant formula from Europe. Recently, the FDA said it would help foreign manufacturers stay in the US market for the long term, in an effort to diversify the supply of formulas here.

Califf previously predicted the formula shortage could last until July. He said Tuesday that retail data shows supplies have improved with increases in US production and imports.

“What you’re going to see is a gradual exit from the current situation as more and more formulas become available,” Califf said.

In May, Califf testified before Congress on the missteps that slowed the agency’s response to the contamination issues at the Michigan compounding plant that sparked the shortage. While many problems arose before Califf began his work, he struggled to explain who was ultimately responsible for food safety within the FDA bureaucracy.

The FDA food program has a byzantine leadership structure in which there is a director of food and a separate deputy commissioner for “food policy and response.” The deputy commissioner is more focused on safety, but has no direct authority over food center staff or regional staff who inspect factories.

“You have serious structural leadership issues,” Rep. Rosa DeLauro told Califf during the hearing.

DeLauro, a Connecticut Democrat, said Tuesday that the FDA’s assessment must contain input from non-FDA experts and interest groups to be credible.

“A report that includes recommendations to preserve the status quo is unacceptable,” she said in an emailed statement.

Responding to multiple crises is integral to the direction of the FDA, which regulates industries that account for about one-fifth of all consumer spending in the United States.

Despite recent controversies, some experts say Califf has done a good job given the growing polarization surrounding FDA-supervised issues and products.

“Running the FDA becomes as complicated, if not more so, than running a cabinet-level executive department,” said Daniel Carpenter, professor of government at Harvard University. “I think Califf navigated a fairly politically charged environment and he did so with remarkable skill.”


Follow Matthew Perrone on Twitter: @AP_FDAwriter


The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.

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