Biden Regulatory Freeze May Pause SUNSET Rule
Tactic aims to allow incoming Administration to scrutinize so-called ‘midnight rules’ issued in the final days of the Trump Administration before they take effect. Regulators may also solicit stakeholder comments on delayed rules.
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Use of preferred and non-preferred specialty formulary tiers will be allowed but preferred tiers are not necessarily limited to generics and biosimilars and coinsurance for non-preferred specialty drugs cannot exceed 33%.
Expiration dates in HHS’ final SUNSET rule exclude OTC drugs after CCHPA and other groups argue the rule would create more problems than it would solve. But dietary supplement regulations are subject to the rule.
Among those judged eligible are FDA rules governing adverse event reporting and the Unique Device Identification System.