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House Maintains Momentum For OTC Monograph Reform, Senate Regard TBD

 
• By Malcolm Spicer

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.

The House Energy and Commerce Committee didn't wait long in the 116th Congress to send to the floor legislation that would overhaul FDA's OTC monograph process. The Senate, on the other hand, has been willing to wait on considering the changes.

The House on Jan. 8 passed, in a 401-17 vote showing large bipartisan support, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019, H.R. 269, which includes language comprising the Over-the-Counter Monograph Safety, Innovation, and Reform Act for modernizing the regulatory system overseeing the vast majority of OTC drugs

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