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House Maintains Momentum For US OTC Monograph Reform, But Senate Remains A Question Mark

Executive Summary

With a new US Congress just convening, OTC monograph reform advocates face an old problem: the need for Senate action. The House has already cleared an OTC reform measure, as part of a pandemic preparedness bill, in the first days of the legislative session.

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OTC Monograph Reform Passes House Again As Clock Ticks On Session

House Energy and Commerce Democrat and Republican members who back monograph reform are co-sponsors of Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, which also includes provisions largely tracking with standalone monograph reform legislation that passed the House in July, including allowing 18-month market exclusivity periods for some ingredients, formulations or indications added to a monograph.

Elections Reshape Congress But Not Supplement Industry Regulatory Outlook

Democrats potentially could target tightening regulatory oversight of some industries after regaining a majority in House, but Trump administration's high priority on reducing regulatory burdens bodes well that legislation to expand FDA's current authorities over the US supplement sector will not emerge before Congress' next session opens in 2021. NJ Democrat Frank Pallone could be member of Congress most commonly mentioned and lobbied by supplement industry during next session as Energy and Commerce chairman.

Exclusivity Period Allowed By OTC Monograph Reform Likely Up To Conference Committee

Next step for OTC monograph reform legislation is Senate consideration; market exclusivity periods are likely focus of House/Senate conference. Separate bill to allow consumers to use health savings accounts to buy OTC drugs without a doctor's prescription clears House Ways and Means panel.

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