In August 2017, PDG published a paper entitled FDA OTC Monograph Changes Coming: User Fees, Pre-submission Meetings and Electronic Submissions. Although not included in the Food and Drug Administration Reauthorization Act (FDARA: included among others PDUFA VI/GDUFA II), the changes have emerged in Senate Bill 2315, introduced on January 17, 2018.
CHPA reported “Today, the House Energy and Commerce Health Subcommittee approved bipartisan draft legislation to reform and modernize the regulatory system that oversees the majority of over-the-counter (OTC) medicines – the OTC Monograph system. The draft bill, authored by Representatives Bob Latta (R-OR), Diana DeGette (D-CO), Subcommittee Chairman Michael Burgess (R-TX), Vice Chairman Brett Guthrie (R-KY), Ranking Member Gene Green (D-TX), and Rep. Debbie Dingell (D-MI), was reported out of the subcommittee by voice vote.” On February 13, 2018, CHPA issued an update noting that “the Administration anticipates a modernized OTC Monograph system will be in place by 2019.”
On February 19, 2018 “PUTTING AMERICA’S HEALTH FIRST FY 2019 President’s Budget for HHS” was updated and included the following statement: “The Budget also includes a legislative proposal to modernize the over-the-counter drug monograph system. The Budget envisions a framework that converts burdensome rulemaking to a streamlined administrative order process; removes barriers to innovation; implements a new mechanism for quickly responding to urgent safety issues; reduces the backlog by finalizing unfinished monographs; and creates a user fee program for over-the-counter monograph drugs. To support this effort, FDA will collect an estimated $22 million in user fee resources in FY 2019 and $134 million over the 5-year authorization.”
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