WAITING IN THE WINGS — A slew of rules is sitting at the White House awaiting the Biden administration’s sign-off before the FDA can issue them. How many — if any — are pushed out the door before President-elect Donald Trump is inaugurated in January remains to be seen. The threat of a Congressional Review Act effort looms over every final rule released until then, and proposals published in that period could languish under the incoming Trump administration. Still, FDA lobbyists point to a few candidates for advancement because they’re either statutorily mandated, not overtly political or both. Tobacco regulation: The Biden White House is sitting on two final rules that would restrict the sale of menthol cigarettes and flavored cigars, but the threat of congressional review could keep them on ice. A former FDA staffer granted anonymity to discuss what regulations Biden could push out before he leaves office noted the uncertainty surrounding what the CRA’s restriction on reintroducing regulations in substantially similar form means. “There is significant downside potentially to putting out a rule banning menthol, having that go through the CRA process, where then the agency would not be able to reintroduce a rule substantially similar to that,” the former FDA staffer said. “So it may decide not to move forward with it at all rather than face that possibility.” Talc in cosmetics: This proposed rule, which would set standardized testing methods for detecting asbestos in cosmetics containing talc, was mandated by the 2022 law overhauling the FDA’s authority over that product class. By law, the agency was supposed to issue the proposal at the end of 2023, but the FDA didn’t send it to the Office of Management and Budget until Jan. 2, where it’s remained ever since. “FDA’s failure to do something as basic as protecting us from asbestos in an everyday product is one of many reasons people have lost faith in the FDA,” said Scott Faber, senior vice president for government affairs at the Environmental Working Group. The law directs the FDA to finalize the rule six months after the proposal’s public comment period closes, though agencies often blow such deadlines. Rx-to-OTC drugs: This proposal is a nonpartisan issue but has floundered at the agency in different iterations for years. The current version — known as “additional conditions for nonprescription use,” or ACNU — would set requirements for over-the-counter drugs that call for more consumer education than a label can provide to ensure users can safely take the medication without provider supervision. An example would be a questionnaire a consumer completes through an app to demonstrate they understand the directions before purchasing the product. When proposing the rule in 2022, the FDA said it would help expand OTC options for consumers and thus help public health. But some in industry and Congress have opposed a portion of the rule that would allow prescription and nonprescription versions of the same drug to be marketed simultaneously, arguing that would illegally undermine the existing regulatory pathway for prescription-to-OTC switches. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. How are the vibes in White Oak? Send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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