This is the third post in our multipart series evaluating the Food and Drug Administration’s (FDA’s) response to the Reagan-Udall Foundation report (the Report) on the operations of the Center for Tobacco Products (CTP). If you missed our prior posts on the Report and FDA’s response, check them out here, here, and here.
In this segment of our series evaluating FDA’s response to the Report (which can be found here and here), we review a subset of the Report’s recommendations and responses from two CTP Task Forces—Cross Cutting and Regulation and Guidance.
Cross-Cutting Task Force
This CTP task force responded to three Report recommendations as summarized below.
Recommendation 1: “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 the Center’s strategic objectives and plots an operational roadmap of the steps CTP will take over the next five years to achieve those objectives.”
- CTP Response:
- “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.”
- “…we will be appointing internal transparency liaisons within each CTP Office, who 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. We will also take immediate actions toward transparency; for example, a new webpage will feature the center’s responses to citizen petitions and we will resume posting scientific policy memos and reviewer guides when appropriate.”
- “We anticipate soliciting stakeholder input on the plan by summer and intend to release the strategic plan to the public no later than December 2023.”
Recommendation 13: “CTP should obtain public input during the development of the Strategic Plan and communicate with stakeholders and the public about the Center’s strategic objectives as well as key messages, and metrics for measuring plan effectiveness.”
- CTP Response:
- “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.”
Recommendation 15: “CTP should improve the overall transparency of the tobacco program, particularly with respect to the regulatory process and its scientific underpinnings.”
- CTP Response:
- “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.”
We agree with the Report’s recommendation that a Strategic Plan is critical to promoting transparency and increasing regulatory certainty for the tobacco industry because it should provide guidance about CTP priorities.
We also agree that CTP’s effort to solicit internal and external feedback in the development of its Strategic Plan is a good idea. A collaborative regulatory approach is critical for an industry that is constantly innovating. For this feedback to be truly effective, however, CTP will need to do more than just listen. It will need to incorporate that feedback into the Strategic Plan.
Finally, CTP’s creation of “transparency liaisons” is an interesting, but undefined response. Are these full-time positions? How will they be integrated into the various disciplines at CTP? How will CTP measure their success? Transforming CTP to include a culture of transparency and information sharing sounds like potential enhancements, but the proof will be in the pudding. CTP’s transparency liaisons should be more than just paper positions and have real influence on CTP’s information sharing. Of course, CTP will need to do more than create transparency liaisons, but it may be a good first step.
Regulation and Guidance Task Force
This CTP task force responded to one Report recommendation as summarized below.
Recommendation 5: “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.”
- CTP Response:
- “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.”
What this should be: CTP should continue to follow the science and require its policy goals to be informed by the science, as defined by the scientists and not by political appointees.
What this should not be: This effort should not override the independence of the experts and it should not be used to drive ideologically driven agendas deep into the organization. CTP’s recent history is rife with accusations of decisional interference and undue external political influence.
Finally, CTP should ensure it develops its policy program in the context of its Strategic Plan and that its actions are tied to goals in the Strategic Plan. If done properly, we believe a clear Strategic Plan complemented by a well-organized policy unit can provide regulatory certainty and implement a process for thoughtful collaboration when it comes to new rules and guidance.