On December 19, the Reagan-Udall Foundation, an independent nonprofit tasked by Congress to help modernize the Food and Drug Administration (FDA), released a commissioned report on the agency’s Center for Tobacco Products (CTP).
The expert panel—which mainly consisted of former agency higher-ups—concluded that the CTP has to pivot from “a reactive mode to proactive mode.”
It identified the lack of a coherent plan at the center charged with authorizing or rejecting vaping products, and called for transparency at an agency long characterized by its absence. Yet Reagan-Udall’s demand for an “operational roadmap” was accompanied by a call for more enforcement tools to be put at the FDA’s disposal.
The almost 40-page report highlighted that Reagan-Udall was “unable to identify a current comprehensive plan that clearly articulates CTP’s priorities, direction for the future, and its near-term and longer-term goals and objectives.” Its sweeping suggestions included improving communications and transparency, perhaps through a potential public meeting; adopting methods to allow more stakeholder input; developing clearer frameworks for “high-quality” marketing applications for nicotine products, and increasing “use of the Tobacco Products Scientific Advisory Committee (TPSAC),” an advisory panel that could help guide the center.
Alex Norcia – Filter – 2022-12-20.
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