FDA receives proposal from Reagan Udall Foundation

The Reagan-Udall Foundation submitted a proposal to Robert Califf, the commissioner of the U.S. Food and Drug Administration (FDA), today. Many industry experts have criticized the findings of the investigation as "meaningless" and "unconvincing.

The report's conclusion is that stakeholders in the e-cigarette industry have observed a lack of "consistent enforcement" in the Center for Tobacco Products' (CTP) policies as they relate to reducing tobacco harm and guiding the application process for premarket tobacco products (PMTA), particularly.

The evaluation of the FDA Tobacco Plan was initiated at the request of Califf. The announcement of this news came as Califf attempted to quell several controversies surrounding his second term as head of the agency, including his issuance of a marketing denial order (MDO) to e-cigarette manufacturer Juul Labs, which he later had to retract.

The report emphasizes several broad issues that hinder the ability of the Center for Tobacco Products (CTP) to regulate the industry and reduce tobacco-related diseases and deaths. The report recommends that the CTP undergo "process improvements and identify and address policy and scientific issues" to support its regulatory framework. The review concludes that the implementation of CTP's plans is also hampered by "leadership and administrative turnover." Over the initial 13 years, the CTP operated under the leadership of seven different commissioners from three different administrative departments, and recently hired its third CTP director, Brian King.

The report states that policy changes that have a widespread impact on the industry have occurred without proper notification to stakeholders. The center is facing significant challenges in clearing its policies through occupational and political infrastructure. It took several years to establish the requirements and standards for managing application reviews, which has frustrated the industry and caused issues within the center itself when flawed applications were received. These issues in the review process have resulted in some applications needing to be re-evaluated and litigated. The current environment reflects an unexpected shift from the legally required pre-listing authorization framework to the reality of post-listing regulatory oversight.

According to the review, assessment, and resulting recommendations, the focus is on four areas of action: regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. The review and recommendations aim to assist the organization in making changes to better fulfill its regulatory responsibilities and strengthen relations with stakeholders.

The author of the report states that it identifies several fundamental issues that the center needs to address, and highlights that the report provides "recommendations for cross-disciplinary and specific projects to help CTP operate more effectively".

The main points of the report can be summarized as follows:

Experts note that the Center for Tobacco Products (CTP) has primarily operated in a passive mode, shifting from one challenge to the next due to external forces. They recommend that the center transition to a more proactive and strategic plan, taking time to strategically consider its position today and where it needs to go in the coming years with substantial engagement with stakeholders and the public. While the CTP's important mission is to protect the public from tobacco-related diseases and deaths and regulate products with no inherent benefit and significant social costs, it is a government regulatory program with a responsibility to operate efficiently, fairly, and transparently. The center's mission, vision, and goals should include the responsibility of an effective product regulatory agency and fulfill that responsibility within its capabilities. The group recognizes that the center needs to improve its process and address policy and scientific issues to support its regulatory framework to increase the effectiveness of its review process. To work more strategically, the CTP should collaborate with other entities to more quickly eliminate illegally sold tobacco products and provide more transparency to the public. While the center can do much on its own, experts point out that compliance with pre-market requirements in tobacco law, especially to help prevent youth tobacco use, requires participation and support from institutions outside of the FDA. The author encourages the organization to elevate this issue and take a more comprehensive approach by leveraging resources from other institutions and announcing a role in tobacco control. Overall, the report suggests that with FDA leadership support, the talented and dedicated CTP staff can address many of the issues presented in the report.

According to reports, many comments evaluated by Reagan Udall, who is said to be an FDA staff member, claim that regulatory agencies are in a state of confusion and are being influenced by external forces rather than scientific research. One comment pointed out that the pre-market tobacco product application (PMTA) reviewers in the CTP Scientific Office (OS) lack the autonomy to exercise "best scientific practices" when reviewing PMTAs. The report failed to address these issues.

The group is comprised of former federal public health leaders, regulatory strategists, and process improvement experts. Lauren Silvis serves as the group's chair, and members include Jane Axelrad, Keith Flanagan, Charlene Frizzera, and Alberto Gutierrez.

The group provided recommendations to assist the tobacco program at the institution in enhancing its operations, as it is committed to reducing harm associated with tobacco use," stated Lauren Silvis. "The Center for Tobacco Products has made significant progress in developing its tobacco product regulatory plan, and our suggestions aim to help the center develop more tools to achieve its public health objectives.

According to the report, the group received and carefully reviewed a range of stakeholder opinions, including those of FDA staff and the public, through multiple listening sessions, interviews, and online portals. The authors claim that the report offers "recommendations for cross-cutting and specific projects" for the FDA to consider, with a focus on regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders.

According to the Reagan-Udall Foundation, the report did not include any tobacco policy issues outside of the scope of evaluation.

An industry insider who refused to be named commented on the report, stating that the investigation results were "a joke" and "completely ignorant of the real issues with CTP." The anonymity was due to concerns that the FDA may retaliate against their brand during PMTA review.

On Monday, Califf stated that he will review the proposals with the aim of outlining the next steps for the organization before February.

Earlier this month, Reagan-Udall submitted a food report commissioned along with the tobacco report. The food report recommends restructuring the leadership of the agency to improve its response to emergencies, including the recent shortage of infant formula.

Reagan-Udall was created by Congress to support the FDA in fulfilling its mission. This non-profit organization receives funding from the FDA and industries regulated by the FDA, including pharmaceutical companies.