US GAO Review Of FDA’s OTC Drug Oversight Signals Waiting For Monograph Reform Benefits
Benefits of OTC monograph reform legislation passed in March likely will take at least several years, according to GAO report to Congress. It notes the FDA still is analyzing the legislation and it may need two years to add and train staff.
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Senate Appropriations Committee has bills for federal agencies’ FY2021 budgets. The committee, which also published each subcommittee’s report accompanying its appropriation legislation, has not scheduled hearings to vote on the bills.
Many questions remain following the late March enactment of the US CARES Act, which overhauls the FDA’s OTC drug regulatory framework and resets the GRASE status of long-used sunscreen drug ingredients whose safety and effectiveness have come under question at the FDA.
With much of FDA's work currently focused on the COVID-19 pandemic, the agency has limited resources available to implement monograph changes authorized by recent legislation. Drug firms awaited a monograph overhaul with expectations for success where they previously failed, but they need FDA's guidance to succeed.