House Maintains Momentum For OTC Monograph Reform, Senate Regard TBD
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.
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Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.
Senate's Over-the-Counter Monograph Safety, Innovation, and Reform Act goes next for consideration by House, which has had a bill by the same title on its floor for a vote since it was passed by Energy and Commerce Committee in late June.
"We believe that we're going to get this done," but "it's possible that ... language authorizing the collection of user fees is not included in this year's appropriation legislation," says Sen. Bob Casey during HELP Committee's confirmation hearing for FDA commissioner nominee Stephen Hahn.