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.
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Kentucky Republican Brett Guthrie is strong proponent of health care affordability and innovation in pharmaceuticals and medical devices. He’s also monitoring FDA’s response to drug shortages and infant formula shortages.
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.