The Food and Drug Administration’s Center for Tobacco Products is making some changes.
Following a review from the Reagan-Udall Foundation, the CTP has outlined several action steps it intends to take based off the foundation’s recommendations. These steps include creating a five-year strategic plan, developing a more efficient framework for high-quality tobacco product application reviews and considering statutory changes to assist the center in enforcing the law, CTP Director Brian King said in a memo Friday.
FDA Commissioner Robert Califf commissioned the external evaluation on July 19, and the 39-page report detailing 15 recommendations for the FDA to make within the CTP was released Dec. 19.
The Reagan-Udall Foundation report validated many criticisms those in the tobacco industry already had with the agency: The premarket tobacco product application (PMTA) process is flawed, the agency’s goals are unclear and enforcement of illegal vapor products is lacking, the report said and industry experts previously shared with CSP Daily News.
“The actions outlined in CTP’s response to the evaluation are a blueprint for action, and there is still much work to be done,” King said. “While some of the report recommendations can be acted upon immediately, others will take time to fully plan and implement, but we are committed to incorporating the activities into CTP’s everyday workflow as expeditiously as possible. Toward that end, we are hard at work planning the timing and prioritization of each activity.”
King said the CTP will continue to provide updates on the center’s progress towards its new goals, including quarterly updates to its new webpage.
“I want to unequivocally reinforce that while CTP is committed to implementing these activities as expeditiously as possible, it will not be at the expense of continued progress on our standard portfolio of activities, as implementation of the recommendations will ultimately strengthen these activities,” King said. “As always, we will be driven by strong science, health equity, stakeholder engagement and transparency. I am proud to be at the helm of CTP during this critical juncture in its history and look forward to optimizing our efforts to best meet the center’s mission of protecting Americans from tobacco-related disease and death.”
Outlined are highlights of the CTP’s response plan, which it divided into the following six sections:
Cross-Cutting
The CTP will immediately initiate development of a comprehensive five-year strategic plan, King said, with the goal of issuing interim strategic goals by summer. Stakeholder input on the plan will be collected by summer and the strategic plan will be released to the public no later than December, he said.
Science and Application Review
The center has started developing a more efficient framework for high-quality tobacco product application reviews, King said.
“Our goals are to work internally and through engagement with external stakeholders to better communicate on scientific issues and practices to support efficiency, effectiveness and transparency; hire additional staff to enhance program management and implementation, including for application review; and increase internal communication to improve scientific engagement and deliberation,” he said.
The CTP will also hold more frequent meetings of the Tobacco Products Scientific Advisory Committee (TPSAC) to gather input on scientific issues related to its regulatory authorities. It is also welcoming a new Office of Science Director on March 26: Matthew Farrelly.
Regulation and Guidance
CTP will immediately initiate the FDA hiring process to create a new policy unit within the Office of the Center Director that would be responsible for providing overall policy coordination across CTP.
Compliance and Enforcement
The CTP will convene a summit with senior officials from the Department of Health and Human Services, FDA and Department of Justice to enhance its compliance and enforcement work.
It will also consider whether statutory changes are needed to assist the center in enforcing the law and explore alternative approaches to achieve compliance outside of judicial enforcement actions through DOJ.
For the first time in October the DOJ, on behalf of the FDA, filed complaints for permanent injunctions in federal district courts against six e-cigarette manufactures, which the agency said failed to submit premarket tobacco product applications (PMTAs) for their e-cigarettes and continued to illegally sell the products despite previous warning.
In February, the FDA filed civil money penalty (CMP) complaints against four tobacco product manufacturers for making and selling e-liquids without marketing authorization. This was the first time the FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug and Cosmetic Act’s (FD&C Act) premarket review requirements for new tobacco products.
King also said the CTP plans to be more transparent about its compliance and enforcement activities and its development of any new enforcement proprieties. It plans to create a comprehensive webpage for all enforcement activities for products that are illegally marketed without FDA authorization. It also has already begun planning for development of a searchable public database of all tobacco products that have an FDA marketing order.
Public Education Campaigns
CTP will develop, publish and promote resources that describe the mechanisms it uses to solicit and consider public input on its public education campaigns. It will also explore new ways for soliciting public input in its campaign program.
Resources
CTP will engage with the relevant entities within the FDA, HHS and the Office of Personnel Management to identify solutions to facilitate more timely and efficient hiring of qualified and diverse professionals who match CTP’s needs, King said.
“Additional user fees for all product types regulated by CTP, including for e-cigarettes, would help the center best achieve our mission, including allowing us to hire more staff to conduct product review and compliance and enforcement actions, among other activities,” he said.
Since fiscal year 2020, CTP has pursued an additional $100 million in user fees for tobacco regulation in its annual budget that is adjusted annually for inflation. Under the FD&C Act, FDA assesses and collects tobacco user feeds from domestic manufacturers and importers of cigarettes, snuff, chewing tobacco, roll-your-own tobacco, cigar and pipe tobacco. The user feeds provide funding for FDA’s tobacco regulatory activities.
Before receiving the Reagan-Udall report feedback, the CTP offices developed an approach for reviewing and assessing the recommendations. The process included establishing six task forces to assess and develop responses and all CTP staff were given the opportunity to provide feedback on the center’s approach to addressing the recommendations, King said. An advisory council of senior FDA leadership was also created to consult the task forces.
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