The FDA’s tobacco program should be proactive, not reactive, an independent panel says after an extensive review


An independent panel of experts says a review of the US Food and Drug Administration’s tobacco program has found numerous wide-ranging problems that hamper its ability to regulate the industry and reduce tobacco-related illness and death.

FDA Commissioner Dr. Robert Califf asked for the review in July, anticipating the complexities ahead with the growing number of tobacco products. Experts were asked to take a closer look at how the agency manages the regulatory process and agency operations, including application reviews, compliance and enforcement actions, and stakeholder and public relations. The panel did not review FDA’s tobacco policy.

After the infant formula crisis, Califf also called for a review of the FDA’s handling of its efforts to keep the U.S. food supply safe, and the resulting report was highly critical.

A new report Monday by a separate panel convened by the Reagan-Udall Foundation said the Center for Tobacco Products’ efforts have had a “measurable impact” but are making the already difficult task of regulating a large industry even more difficult. product introductions, repeated changes in management and constant litigation.

Although the center has a “critical mission to protect public health from tobacco-related illness and death and regulates products with no benefit and great public cost, it is a government regulatory program committed to operating efficiently, fairly, and equitably. it is carried out in a transparent manner”, the report states. Instead, he was “forced to operate primarily in a reactive mode, bouncing from one challenge to the next.”

The panel even found a lack of clarity about the center’s goals and priorities, and a lack of transparency and communication. There were also concerns about the need for stakeholder and public input, as well as policy changes that occurred without notice and were inconsistently implemented.

When Congress passed the Tobacco Control Act of 2009, the FDA was given the authority to regulate the marketing, manufacture, and distribution of tobacco products. Manufacturers were required to submit an application to the agency and obtain a marketing permit before selling any new tobacco products.

The goal was to give the agency the ability to create regulations that would protect Americans’ health, but critics say it’s a fundamentally flawed effort because the products are harmful to health.

The Center on Tobacco Products has also faced criticism from anti-tobacco advocates who say the agency has been too slow to act and is missing court-ordered deadlines to regulate e-cigarettes.

This month, the U.S. Department of Health and Human Services’ Office of Inspector General released a report criticizing the FDA for failing to monitor online tobacco retail sales, saying that children’s tobacco use remains a “high concern” and that online sales are a potential opportunity for children to purchase products without verifying their age. the easy way.

According to the US Centers for Disease Control and Prevention, in 2022, approximately 17% of high school students, or more than 2.14 million high school students, reported using e-cigarettes. 1 out of every 30 high school students, or about 3.3%, reported using e-cigarettes in the past 30 days. For middle school students, the CDC says it’s 1 in 7 students. For smoking, 1 in 100 high school students smoked in the past 30 days in 2022, up from 2 in 100 high school students, according to the CDC.

Public health experts are concerned about youth use of tobacco products because it can become a lifelong habit. 9 out of 10 adult daily smokers try their first cigarette by age 18.

Since its inception, the Tobacco Products Center’s workload has grown “almost exponentially,” a new report says: It received 432 premarket applications for tobacco products as of October 31, 2019, but more than 8 million in fiscal year 2020. applied. alone The large number of applications being processed left the staff exhausted; the tobacco industry and public health advocates, in turn, are frustrated and are suing to address their concerns.

The report states: “Stakeholders have observed that the current application review process is extremely difficult and time-consuming, with submission requirements characterized as vague and frequently changing. And with so many filings, “The current environment reflects an unexpected transition from the law being structured as a pre-market authorization framework to the reality of a post-market regulatory environment.”

This environment has its challenges. Some manufacturers even continue to sell their products without marketing approval due to the lack of FDA action, even by “submitting defective applications or making frivolous applications to further delay enforcement actions.” But the enforcement process is long and difficult, and the final decision on whether to take punitive action against a company rests with the US Department of Justice, not the FDA.

The review panel recommended four key areas for improvement and offered recommendations “to help the Center develop additional tools to achieve its public health goals,” panel chairwoman Lauren Silvis said in a statement.

First, the Tobacco Products Center needs to be more proactive and strategic in thinking about where it stands and where it needs to go, the report says. “CTP should spend time with staff and public input to create and implement a Strategic Plan that identifies the Center’s strategic goals and lays out an operational roadmap for the steps CTP will take to achieve those goals over the next five years.”

The panel also suggests improving transparency and communication, clarifying expectations for the industry, and seeking public opinion on topics such as its education campaigns.

The center should improve its application review process, the report says, by developing a “clearer and more predictable framework” and clearly defining application requirements and expectations.

The Council also proposes to work with other agencies on implementation. “The FDA cannot single-handedly change the current tobacco enforcement paradigm. If tobacco law enforcement is a priority for the Agency and the Administration, significant resources should be devoted to creating enforcement processes that are more effective in ridding the market of illicit products, especially given the disproportionate impact of illicitly marketed tobacco products on youth public health. products.”

An interagency task force that includes the FDA, DOJ, the US Department of Health and Human Services and the Treasury Department could streamline the enforcement process and increase the consequences of violations, the report said. FDA may also consider independent approaches that do not require DOJ assistance, including “high-profile actions against wholesalers and distributors.”

Health officials will review the report over the next several weeks, Califf said in a statement Monday, with an update on next steps by early February.

“In the 13 years that Congress has mandated FDA to regulate tobacco products, we have made significant progress and made science-based regulatory decisions on a wide range of products,” he said. “Greater challenges and opportunities lie ahead as we determine how the agency will navigate complex policy issues and enforcement actions for the growing number of new products that could potentially have significant public health impacts.”

Erica Sward, assistant vice president of national advocacy for the American Lung Association, noted that the Tobacco Products Center is “a new center with a different mandate.” “It’s a really important reminder to have a strategic focus and get ahead of the curve and see that this can’t just be the responsibility of one center at the FDA, but that the whole of government needs to work together to really reduce the number one cause of preventable death in the United States.”

If manufacturers who market their products illegally see law enforcement agencies such as the Justice Department cracking down on other companies, “eventually they will think twice about selling their products in the United States,” he said, “but we’re not at that tipping point yet. We need more enforcement of the law.”

However, “we want the FDA to be primarily a public health agency, and we want the Center for Tobacco Products to work to protect public health,” Sward said. “Promoting harm reduction is not FDA’s responsibility or obligation under the Tobacco Control Act. … Its responsibility is to stop the sale of products that do not meet public health standards. And finally, it means the FDA must do more to remove all flavored tobacco products from the market, including menthol cigarettes and flavored cigars.

The tobacco industry is “doing everything it can to sabotage the center’s efforts,” he said, including flooding its system with applications “so it can then claim that the FDA is lagging and delaying.” But the American Lung Association is confident that “under Dr. Califf’s leadership [Director Brian King]the center will improve,” Sward said.

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