Actions to Address Recommendations from the Reagan-Udall Evaluation of CTP
On this page:
- Background: Reagan-Udall Foundation (RUF) Evaluation
- CTP's Review of the Evaluation Report
- Recommendations and Actions
Background: Reagan-Udall Foundation (RUF) Evaluation
In September 2022, per the request of the FDA Commissioner, Dr. Robert Califf, an independent expert panel facilitated by the Reagan-Udall Foundation began an operational evaluation of the agency’s Center for Tobacco Products (CTP). The evaluation’s goal was to help ensure that CTP has the tools to address today’s challenges as it works to prevent tobacco use among youth and to reduce tobacco-attributable death and disease.
The evaluation assessed processes and operations related to several topic areas within CTP’s portfolio, including:
- Regulations and guidance,
- Application review,
- Compliance and enforcement, with a focus on efforts to remove illegal products from the market, and
- Communication with the public and other external stakeholders.
The final report from the operational evaluation’s independent expert panel included 15 recommendations, which were released on December 19, 2022. Subsequently, CTP was charged by the Commissioner with leading the agency’s response to the recommendations, including developing a plan to meaningfully address the report’s findings and recommendations.
CTP's Review of the Evaluation Report
The approach used by CTP to review and respond to the evaluation recommendations was described in a statement released by the CTP Director. In brief, in January 2023, CTP convened six distinct task forces to address the recommendations, which were led by relevant center leadership for the topic area of focus. The task forces were comprised of agency staff with relevant subject matter expertise for each topic area, both across CTP and in other relevant FDA offices.
The task forces included:
- Science and Application Review
- Regulation and Guidance
- Compliance and Enforcement
- Public Education Campaigns
To ensure broad CTP staff engagement beyond just those serving on the task forces, a survey was sent to all CTP staff to seek their input on the report findings and actions to address the recommendations. The staff input was shared with the relevant task forces. The task forces convened throughout January 2023, during which they deliberated over actions to address the recommendations.
CTP welcomed the opportunity for the evaluation and appreciates the work of the independent expert evaluation panel. CTP is committed to addressing all 15 recommendations in the report as quickly as possible. Implementation of some recommendations will take time and others will require collaboration, including with federal partners outside FDA. Therefore, some activities will take longer to be initiated or completed. But regardless of whether these planned actions are immediate or long-term, CTP will continue to provide public updates on progress in achieving them.
Information on the status of CTP activities to address each recommendation are provided below, by topic area. The recommendation numbers correspond to those in the panel’s report. These activities will be updated routinely to reflect CTP’s latest progress.
Recommendations and Actions
To address today’s challenges and position itself for the future, CTP must pivot from a reactive mode to a proactive mode. CTP must invest the time, now, with staff and public input, to create and implement a strategic plan that identifies CTP’s strategic objectives and plots an operational roadmap of the steps CTP will take over the next five years to achieve those objectives.
- Effective immediately, CTP will initiate the development of a comprehensive 5-year strategic plan that will include robust internal and external engagement during its development, including the issuance of interim strategic goals by summer 2023. Development will begin by February 2023, with an anticipated release date of the comprehensive strategic plan no later than December 2023. The development of the strategic plan will include consideration of all the specific sub-components suggested by the evaluators, as well as elements to advance health equity.
CTP should obtain public input during the development of the strategic plan and communicate with stakeholders and the public about CTP’s strategic objectives as well as key messages, and metrics for measuring plan effectiveness.
- By summer 2023, as part of the larger strategic planning process that includes input from internal FDA staff and stakeholders, CTP will implement a robust external engagement plan to obtain public input on the strategic plan.
- Effective immediately, CTP will routinely communicate with stakeholders and the public about progress related to the strategic plan, including through regular updates to our webpage. Updates will include information related to development, strategic goals, release, and status of center activities to address each objective within the strategic plan.
CTP should improve the overall transparency of the tobacco program, particularly with respect to the regulatory process and its scientific underpinnings.
- By spring 2023, CTP will develop an operational strategy that facilitates a culture of enhanced transparency and information sharing, both internally within CTP and externally with stakeholders and the public.
- Effectively immediately, CTP will initiate activities to enhance transparency and information sharing across all programmatic areas, including establishment of internal transparency liaisons within each CTP office. These transparency liaisons will be responsible for objectively identifying areas for transparency enhancement, working with necessary personnel in their office to implement changes, and monitoring progress over time.
Science and Application Review
CTP should increase its use of the TPSAC to obtain expert input on scientific issues and policy development, including regulations, guidance, and data needs for effective product regulation.
- Effective immediately, CTP will work to increase use of TPSAC to obtain input on scientific issues related to its regulatory authorities; the next meeting will be held by fall 2023, with a goal of holding one or more TPSAC meetings per year. CTP will reassess and update the center’s criteria for holding a TPSAC meeting and will also reassess and update criteria for other types of convenings to discuss scientific issues. The topics brought before TPSAC may include broader scientific matters central to premarket evaluation, as well as discussions of individual product applications. CTP will also ensure that the necessary internal infrastructure is in place to support increased use of TPSAC.
CTP should develop a more clear and predictable framework for high-quality premarket tobacco product application (PMTA) and modified risk tobacco product (MRTP) application submission and reviews.
- Effectively immediately, CTP will undertake several actions to develop a more efficient framework for high-quality reviews, including: working internally and through engagement with external stakeholders to better communicate on scientific issues and practices to support efficiency, effectiveness, and transparency; hiring additional dedicated personnel to enhance program management and implementation, including for application review; and increasing internal communication to improve mechanisms for scientific engagement and deliberation.
- By the end of 2023, CTP will conduct a public meeting to explain current review processes and solicit external feedback; and explore options for providing more transparent and timely dissemination of information, as appropriate. In addition to a public meeting, future means of communication will include continued convening of webinars and issuance of guidance to industry. Beginning in spring 2023, CTP staff will present in public forums about our scientific processes. By spring 2023, we will resume the posting of scientific policy memos and reviewer guides, when appropriate.
Consider clarifying in formal policy CTP’s plans for triaging its substantive reviews to conserve resources when there are certain critical sections of the application that can be indicative of whether all sections of the application merit review.
- By spring 2023, CTP will initiate efforts to provide additional information about the center’s process for premarket reviews, including through presentations at symposiums, conferences and meetings where the center engages with stakeholders. CTP will also host at least one public meeting in 2023 to describe the processes for premarket review and provide an opportunity for stakeholder input.
- Effective immediately, CTP will explore additional options to structure reviews to be more flexible and less resource intensive, and so that efforts are more efficient. This includes continuing to explore topics for which a streamlined review could be implemented and including this issue in the public meeting to engage stakeholders in the discussion.
Regulation and Guidance
Recommendation 5: Create a More Effective Approach to Achieve Regulatory Review and Enforcement Goals
CTP should evaluate and redesign the current policy development program to create a more effective approach to achieving the regulatory review and enforcement goals that CTP establishes.
- Effective immediately, CTP will initiate the FDA hiring process to create a policy unit within the Office of the Center Director that would be responsible for providing overall policy coordination and issues management across CTP.
- By the end of 2023, CTP will develop, publish, and maintain a comprehensive policy agenda of rules and guidances that are in development or planned for development; development of the policy agenda will begin by February 2023, with an anticipated completion date of no later than December 2023. As part of developing this policy agenda and developing the strategic plan, CTP will solicit stakeholder feedback on potential rules and guidances related to the application review process, policies related to compliance and enforcement matters, and on ways to increase efficiency during the application review process. CTP will undertake an evaluation and redesign of our policy development program to create a more efficient approach to meeting CTP’s strategic plan. Following the initial publication, CTP will update the policy agenda annually.
- Effective immediately, CTP will explore alternative approaches to increasing transparency and opportunities for stakeholder feedback, which will be a focal point of action in redesigning the policy development program. Examples may include utilizing more public meetings when rolling out proposed rules to increase understanding of the proposals and utilizing advance notices of proposed rulemaking (ANPRM) to provide opportunities to engage stakeholders earlier in the rulemaking process.
Compliance and Enforcement
FDA should seek higher-level administration involvement to establish an interagency task force to make enforcement of the tobacco laws a government-wide priority, particularly to address the marketing of illegal products and the risks of youth use.
- Effective immediately, FDA will begin planning to convene a summit related to enforcement with senior officials from U.S. Department of Health and Human Services (HHS) Office of General Counsel (OGC) (including FDA Office of Chief Counsel), FDA Office of the Commissioner, CTP, and Department of Justice (DOJ).
- Effective immediately, FDA plans to continue activities with other government agencies and organizations to enhance enforcement and compliance activities. In addition to DOJ, these agencies and organizations include, but are not limited to: U.S Customs and Border Protection, the U.S. Postal Service, the Federal Trade Commission, Bureau of Alcohol, Tobacco, Firearms and Explosives, as well as with our compliance and enforcement partners at the state/local/territorial/tribal levels.
The agency should consider whether statutory changes to provide streamlined processes for tobacco enforcement, including increased consequences for Tobacco Control Act (TCA) violations, should be pursued.
- Effective immediately, CTP will consider whether statutory changes are needed to assist CTP in enforcing the law. If statutory changes are needed, CTP in coordination with relevant FDA and HHS offices and the administration, will seek such changes from Congress.
In addition to pursuing formal enforcement through DOJ, FDA should explore alternative approaches to achieving compliance.
- Effective immediately, CTP will explore alternative approaches to achieve compliance outside of judicial enforcement actions through DOJ. Approaches will include those related to enforcement priorities and developing additional website content to effectively educate industry and encourage voluntary compliance with FDA’s premarket requirements for new tobacco products. CTP has begun planning some of these activities.
Recommendation 11: Enhance Communication to Provide Greater Transparency on Compliance and Enforcement
CTP should enhance its use of public communications to provide greater transparency about the agency’s approach to compliance and enforcement, including prominently posting and maintaining a list of legally marketed products to facilitate voluntary compliance and discourage the sale of illegal products by manufacturers, distributors, wholesalers, and retailers.
- Effective immediately, CTP will be more transparent about its compliance and enforcement activities and its development of any new enforcement priorities. CTP plans to create a comprehensive webpage for all enforcement activities for products that are illegally marketed without FDA authorization, routinely reach out to industry trade groups and other industry stakeholders to keep them apprised of the development of new enforcement priorities and updates, enhance FDA’s Tobacco Product Marketing Order webpage, and develop a searchable public database of all tobacco products that have an FDA marketing order. This work has already been initiated, and the new web content will begin to be posted by spring 2023.
The center should ensure that the workplan and goals for the Office of Compliance reflect any new priorities that the center adopts as a result of its evaluation of additional enforcement approaches.
- By the end of 2023, CTP’s Office of Compliance and Enforcement will develop a new strategic plan related to this recommendation and it will be in alignment and in coordination with CTP’s new 5-year strategic plan; development has been initiated.
Public Education Campaigns
The center should solicit broad public input as it continues to develop its tobacco public education campaigns, which are critical to the public health mission.
- By spring 2023, CTP will develop and implement a plan to develop, publish, and promote CTP resources that describe the mechanisms CTP currently uses to solicit and consider public input on its campaigns, including formative research with campaign audiences, consultation with stakeholders, Federal Register notices, engagement at conferences, and analysis of social media posts. CTP will leverage opportunities to solicit and consider public input during upcoming public meetings on topics relevant to CTP campaign and public education strategy.
- Effective immediately, CTP will begin exploring a collaboration with an external entity known for scientific rigor and objectivity to develop and test a credible, sustainable, and comprehensive process for soliciting and considering public input on CTP’s campaign program. Feasibility of this approach will be determined within 3 months.
Recommendation 3: Improve Abilities to Recruit, Hire, and Retain Personnel to Meet Public Health Mandates
FDA should secure the agile hiring authorities and salary flexibility of the 21st Century Cures Act for the tobacco program to improve its ability to recruit, hire, and retain personnel with the needed skills to effectively meet its public health mandate around tobacco. FDA should also work with the Office of Personnel Management to develop solutions to facilitate hiring professionals that match the program’s needs.
- Effective immediately, FDA will continue to work with Office of Personnel Management (OPM) to develop solutions to facilitate and expedite hiring professionals that match CTP’s needs.
- Effective immediately, CTP will continue to engage with FDA, HHS, and OPM to identify solutions to facilitate more timely and efficient hiring of qualified and diverse professionals that match the center’s needs. Toward this end, CTP is currently partnering with OPM to potentially establish an Intra-Agency Agreement for additional hiring support. In addition, FDA is working with HHS to submit to OPM a new request for direct hire authority for the tobacco program.
The agency should continue to pursue securing user fees from each sector regulated by the center, including, for example, electronic nicotine delivery systems.
- FDA has pursued securing user fees for all products CTP regulates. In order to incorporate all deemed products into the tobacco user fee methodology and provide for an increase in user fees assessed and collected, FDA will work with Congress to modernize the tobacco user fee framework.
- Since fiscal year 2020, FDA has requested an additional $100M in user fees, indexed for inflation, in our annual budget and authority to include all deemed products among the tobacco classes for which FDA assess tobacco user fees.
- CTP has worked with appropriate FDA offices to educate relevant stakeholders, including Congress, about the beneficial impact that securing additional user fees for all regulated tobacco products would have on CTP’s ability to meet its regulatory mandate. An additional $100 million in user fees is critical for CTP to bolster tobacco regulatory activities across a variety of program areas, including increasing compliance and enforcement efforts, hiring more staff to handle the large volume of complex product applications, maturing CTP’s research programs to support regulatory priorities, and expanding formative research and public education campaigns.