US Regulatory SUNSET Misses FDA’s OTC Drug Regulations, But Reaches Supplement Rules
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.
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US HHS says rule, which would require reviews of most regulations every 10 years, would gobble up departmental resources and hurt public health.
Former FDA Commissioner Scott Gottlieb says OTC drug switch sponsors could expedite introduction of agency’s long-awaited proposed rule on switch NDAs by submitting applications. During CHPA webinar, he said innovation by industry guides agency in rulemaking.
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.