US Health Market In 2019: Unfinished Business Leaves Lasting Impression
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.
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Total GMP warnings in FY19 was 98, more than half to US firms. Warning to Dollar Tree “should serve as a reminder that although distributors may not be subject to CGMP requirement themselves, they are responsible for ensuring the drugs they distribute into interstate commerce are not adulterated,” says CDER compliance chief Donald Ashley.
Sanofi eyes $1bn top line growth from OTC switches of ED drug Cialis and flu drug Tamiflu after they launch by 2026, says CEO Paul Hudson. Like switch consultants, though, he acknowledges the high bar for approval moving additional Rx ingredients to OTC.
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.