Comments in FDA Assessment Suggest Agency in Disarray

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    The U.S. Food and Drug Administration is in disarray and influenced by outside forces rather than scientific research, according to several comments submitted to the Reagan-Udall assessment of the performance of the FDA’s Center for Tobacco Products (CTP).

    In July, the FDA commissioned an independent review of the agency’s food and tobacco programs following months of criticism over its handling of a baby formula shortage and e-cigarette reviews. FDA Commissioner Robert Califf chose the nonprofit Reagan-Udall Foundation, a nongovernmental research group created by Congress to support the FDA’s work, to perform the review.

    As part of its work, the Reagan-Udall Foundation has been soliciting feedback from stakeholders.

    Many of the comments paint a picture of an agency struggling to fulfill its mandate.

    One commenter said that reviewers of premarket tobacco product applications (PMTAs) in the CTP Office of Science 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),” this person wrote.

    “In some divisions (e.g., Division of Nonclinical Science), 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.”

    Another commenter claims that arbitrary and politically driven timelines set externally (by a judge for example) are driving reviews as opposed to allowing for a thorough scientific review. “When errors are found, the CTP reviewers are blamed when in fact the lack of adequate time to complete the reviews are at fault.

    “Staff are burned out and constantly told to do more in less time and blamed for not meeting insane deadlines,” the commenter wrote. “In cases where reviews are finished and scientific decisions are made, they are also overruled by political agendas and pushed to change decisions.”

    To read all comments, please visit the Reagan-Udall Foundation’s stakeholder portal.