“The U.S. House Oversight and Accountability Committee will investigate the practices of the Food and Drug Administration’s Center for Tobacco Products (CTP). Chairman James Comer is conducting the probe of the FDA’s regulation of tobacco and nicotine products through the CTP. The CTP has failed to effectively define and administer its tobacco and nicotine regulatory programs, resulting in industry uncertainty and unsafe products reaching the marketplace, according to a committee press release. In a letter to FDA Commissioner Robert Califf, Comer is requesting documents, communications and a staff-level briefing related to the CTP’s activities to ensure it is performing its regulatory function as intended. “We have deep concerns that CTP’s decisions have been influenced by political concerns rather than scientific evidence,” wrote Comer.“ Comments from FDA staff to RUF, which are no longer available on its website, reflect such concerns.
For example, one commenter said, ‘[i]n cases where reviews are finished and scientific decisions are made, they are also overruled by political agendas and pushed to change decisions.’ Another stated, ‘scientific disagreement is frowned upon, if not entirely suppressed,’ while a third said leadership was ‘… unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.’ FDA must clearly identify and publicize what scientific criteria are necessary for a product, to include [electronic nicotine-delivery system (ENDS) products] and smokeless products, to be authorized through the PMTA pathway and—where appropriate—the subsequent [modified-risk tobacco product applications (MRTPs)] pathway.”
ARTLICLE LINK: House Oversight Committee to Probe CTP
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