Numerous comments from purported staffers of the U.S. Food and Drug Administration for the Reagan Udall assessment of the performance of the FDA’s Center for Tobacco Products (CTP) claim the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research.
One comment stated that reviewers of premarket tobacco product applications (PMTAs) in the CTP Office of Science (OS) lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs.
“Scientific disagreement is frowned upon, if not entirely suppressed, and punished through various backhanded methods (e.g., lack of assignments, projects, and other opportunities that are needed for career development/promotion),” the comment states. “In some divisions (e.g., Division of Nonclinical Science [DNCS]), leadership pushes a ‘gotta get em’ mentality onto staff, which is unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.”
In July, the FDA commissioned an independent review of the regulatory agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews. FDA Commissioner Robert Califf chose the non-profit Reagan-Udall Foundation, a non-governmental research group created by Congress to support the FDA’s work…
VaporVoice – 2022-10-28.
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