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Is CTP’s response to the Reagan-Udall report just a lot of hot air?
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While it is quite clear CTP did not fare too well in its evaluation by the Reagan-Udall foundation panel, what remains to be seen is how well it will act and improve.
Last July, US Food and Drug Administration (FDA) commissioner Robert Califf ordered a “comprehensive evaluation” of the Center for Tobacco Products (CTP) in the wake of a slew of criticism over the agency’s handling of premarket tobacco product applications (PMTA); issuing an administrative stay on its own marketing denial order that Juul pull its products from the US market; and senators Dick Durbin (D-Ill.) and Susan Collins(R-Maine) calling out what they perceived to be the agency’s lack of action in regards to the synthetic nicotine ban.
Despite initial reservations and skepticism shared by public health advocates and tobacco industry players alike, results from the review, conducted by an independent, five-member panel of experts from the Reagan-Udall Foundation (most of whom were former high-ranking FDA staff), were not in CTPs favor.
CTP deemed “reactive and overwhelmed” Focusing on four specific areas – regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders – the panel found CTP to be “reactive,” its staff “fatigued,” and its constituents (namely public health advocates and the tobacco industry) “frustrated”. The report described how the workload associated with the PMTA process and other regulatory oversights CTP has been tasked with is too much for CTO to handle. It also said CTP has “struggled to function as a regulator.”
The review also highlighted CTP’s “lack of clarity, transparency, and communication” as a recurring issue across the four evaluated areas.
In regards to its goals and priorities, the panel found that CTP is “unclear in communication and practice,” adding that the panel was unable to identify a comprehensive plan that clearly identifies CTP’s priorities, future direction, as well as near- and long-term goals and objectives. This contributes to a lack of public and stakeholder input into CTP’s regulatory, scientific, and enforcement priorities and policies.
For application review, the panel determined that “CTP must do a better job of explaining how and why it weighs the evidence, explicitly quantifying the trade-offs it is willing to accept, and distinguishing policy judgments from scientific information and determinations.” Pointing out that a lack of clarity means extraneous work for both applicants and CTP, the panel said, “CTP has a responsibility to clearly identify application requirements, if for no other reason than to reduce the burden on the Agency itself and improve efficiency.”
In terms of compliance and enforcement, the panel acknowledge that while CTP and FDA cannot independently bring enforcement actions in court and require the US Department of Justice (DOJ) to do so on FDA’s behalf, failure to take timely action against illegal products in the market not only jeopardizes public health but also undermines FDA’s credibility and effectiveness in tobacco regulation. The panel recommended establishing an interagency task force to make enforcement of tobacco laws a government-wide priority, exploring alternative approaches to pursuing enforcement through DOJ, and better using public communications to provide greater transparency about the agency’s approach to compliance and enforcement.
Communication with the public and other stakeholders is consistently a weak point for CTP. The panel said CTP could use its communication more strategically to improve its overall transparency particularly over its processes, the state of the science involved, and regulatory decision-making as well as obtain more public input.
FDA/CTP’s (somewhat) underwhelming response
Following the report on the evaluation findings and recommendations which came out in December last year, in late February FDA commissioner Califf called upon Congress to approve a user fee agreement with the e-cigarette industry to fund “the enormous workload” the agency has had to struggle with. “To achieve these goals, we need to have the appropriate resources to hire and retain staff with the skills needed to effectively meet our public health mandate around tobacco,” Califf said.
In a statement, CTP director, Brian King, provided more details about CTP’s action plan, which includes developing a five-year strategic plan; designating internal transparency liaisons within each CTP Office who would be in charge of impartially identifying opportunities to improve transparency; resuming posting scientific policy memos and reviewer guides “when appropriate”; building a new webpage to showcase its responses to citizen petitions; hiring more staff and increasing internal communication; utilizing the Tobacco Products Scientific Advisory Committee more for its input on scientific issues; and organizing a meeting with the US Departments of Health and Human Services and Justice to examine how CTP should enforce its compliance efforts.
Skeptics may believe CTP’s announced plans to be merely empty words or a lot of hot smoke that are unlikely to yield real action or effect change. And that belief may not be too far off the mark.
Last December, two memos submitted to the US Court of Appeals for the 3rd Circuit revealed that the office of director King intervened to oppose the CTP Office of Science’s (OS) recommendation to approve Logic Technology’s menthol vaping products. The memos were part of Logic’s petition for a stay of the marketing denial order (MDO) issued for its menthol vapes. Logic’s legal team said the memos reveal the extraordinary fact that OS reversed its science-based recommendation to issue marketing granted orders for Logic’s PMTA for its menthol-flavored electronic nicotine-delivery systems [ENDS] after receiving pressure from the new CTP director and his office, the Office of Center Director [OCD].”
In the first memo dated October 25, OS said it examined Logic’s PMTA, including its product-specific evidence, and concluded that authorizing the marketing of Logic’s menthol-flavored ENDS was appropriate for the protection of public health. However, OS reversed course after King and OCD, to whom OS reports, concluded that all menthol-flavored ENDS should be treated as disfavorably as a category.
In the second memo, the same change in policy is reiterated, and it is implied that meetings were held to address OS staff concerns about the propriety of the decision-making process that led to the rejection of Logic’s menthol PMTA.
OS was also worried that the new OCD strategy would remove all ENDS products with flavors other than tobacco. Effecting change in CTP and how it works would likely require more than a five-year plan, a new website, more meetings among different departments, and high-ranking officials paying lip service to transparency and improved communication. Old habits may just be too ingrained in the center’s leadership.