FDA weighs oversight changes after formula, Juul issues

FDA weighs oversight changes after formula, Juul issues
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WASHINGTON (AP) — The director of the Food and Drug Administration (FDA) has called for a review of the agency’s food and tobacco programs after months of criticism over its handling of formula shortages for babies and e-cigarette reviews.

Tuesday’s announcement comes as FDA Commissioner Robert Califf tries to overcome several controversies that have dominated his second term at the helm of the agency, including the late response to contamination problems at the world’s largest infant formula plant. country.

“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 center, which regulates traditional cigarettes and vaping products, faces challenges in navigating policy and enforcement issues of “a growing number of novel products that could have significant public health consequences,” said.

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

The ad review comes a day before Califf is due to testify before the Senate agriculture committee on FDA oversight of food safety.

More than two dozen consumer groups have asked Califf to appoint an official to oversee all of FDA’s food operations, which are spread across multiple centers responsible for nutrition standards, plant 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 solution, or leadership alone is the solution,” Califf said. “There is an ongoing concern that we really need to fix the fundamentals, which includes all of those elements.”

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 annually in user fees from industry. The agency recently sought 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 leading US vaping company. A federal court quickly blocked the agency’s order. fda then regressed more in court, saying he needed more time to review Juul’s application because of its “unique scientific issues.”

The FDA has also had trouble reviewing millions of other vaping company applications, leading to multiple missed regulatory deadlines in the past two years.

Califf brought up funding challenges again, noting that the FDA cannot collect user fees from vaping companies that ship their products. The agency has asked Congress for that authority.

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

Last week, the FDA announced it would lose another deadline to phase out thousands of illegal e-cigarettes that use synthetic nicotine. FDA officials specifically asked Congress to give the agency authority over those products, which had used a loophole to circumvent regulation.

Sen. Dick Durbin, an Illinois Democrat, suggested Califf should resign if the agency can’t quickly phase out such products.

President Joe Biden caliph beaten for the FDA job in large part because of his previous experience with the agency, which he led briefly during the Obama administration. Califf, a respected cardiologist and researcher, planned to focus his time at the FDA on combating medical misinformation and optimizing the agency’s data systems.

But those efforts have been overshadowed by new controversies, including political outrage over the scarcity formulathat has forced the US air lift million containers of formula from Europe. The FDA recently said it would help foreign manufacturers stay in the US market long-term in an effort to diversify the supply of formula here.

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

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

In May, Calif. tested before congress about missteps that delayed the agency’s response to contamination problems at the Michigan formula plant that caused the shortage. While many of the problems occurred before Califf started work, he had trouble explaining 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 food director and a separate deputy commissioner for “food policy and response.” The deputy commissioner focuses more on safety, but has no direct authority over food center staff or regional staff who inspect plants.

“He has serious structural leadership problems,” the representative said. Rosa DeLauro told Califf during the hearing.

DeLauro, a Democrat from Connecticut, said Tuesday that the FDA 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,” he said in an emailed statement.

Responding to multiple crises is a standard part of leading the FDA, which regulates industries that account for about a fifth of all US consumer spending.

Despite the recent controversies, some experts say Califf has done a good job, considering the growing polarization around the issues and products the FDA oversees.

“Running the FDA is becoming just as complicated, maybe more complicated, than running a cabinet-level executive department,” said Daniel Carpenter, a professor of government at Harvard University. “I think Califf has navigated quite a tense environment politically and done so with remarkable skill.”


Follow Matthew Perrone on Twitter: @AP_FDAwriter


The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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