Monograph Reform Legislation In Play As FDA, OTC Industry Get Real On Changes
FDA and CHPA preparing for changes to monograph procedures the agency and industry negotiated, including a user fee program, and are included in legislation passed by House and introduced in Senate. But neither the agency nor the trade group expects to be entirely ready before the legislation passes, whenever that might be.
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In draft guidance on format and content for OMORs, CDER framed recommendations by same model it’s used for guidances on other drug applications, common technical document for registration developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
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.
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.