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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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.
A Good Guidance Practices regulation from the US HHS, pushed through the rulemaking process in the waning days of the Trump administration, will likely delight the medtech industry and be pushed back on by the FDA, experts tell Medtech Insight.
It’s unlikely any industry stakeholder or FDA official expected a bill providing emergency economic relief to consumers, industries and health care services and facilities in response to a pandemic, including extensive support opportunities for small businesses, would be the vehicle that delivers on both of the industry’s congressional wishes. The supplement industry also looks for help in CARES Act.