OTC Monograph Reform May Have To Launch Without User Fees, Senate Sponsor Says
"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.
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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.
HELP Committee ranking member Patty Murray said because of Hahn's evasive responses to questions about curbing youth e-cigarette use during committee meeeting, she would oppose his confirmation. She also said she was not convinced Hahn would uphold FDA standards.
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.