Exclusivity Period Allowed By OTC Monograph Reform Likely Up To Conference Committee
This article was originally published in The Rose Sheet
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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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.
House passes, with large bipartisan support, Pandemic and All-Hazards Preparedness and Advancing Innovation Act, which includes Over-the-Counter Monograph Safety, Innovation, and Reform Act for modernizing FDA's system overseeing vast majority of OTC drugs. Provisions would allow FDA to use administrative orders, rather than notice-and-comment rulemakings, to add ingredients, dosages, delivery formats or indications to monographs, or drugs marketed without approved applications.
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.