US FDA And OMB Should ‘Pause’ Billion-Dollar Quality Metrics Program, Industry Groups Say
High projected cost and low perceived benefit merits further dialogue on US FDA's quality metrics initiative, industry coalition says. One group might tap into Trump administration's anti-regulatory view in advising budget office that compliance could cost industry $1bn per year. Groups question whether initiative could wind up causing drug shortages instead of preventing them.
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Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.
High ratings could strengthen company financial performance, agency suggests. But stakeholders would need to understand the difference between site QMM and product quality for the incentives to work properly. More details to follow in upcoming workshop.
Based on industry feedback from pilot programs, agency proposes for discussion a layered approach to quality metrics reporting that industry sectors and individual manufacturing facilities could tailor to their needs.