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FDA's Framework for Regulation Review: Ensuring Modernized and Effective Policies

On March 10, 2011, Leslie Kux, Acting Assistant Commissioner for Policy at the FDA, outlined the importance of reviewing regulations to adapt to evolving circumstances. The framework reflects on mechanisms established since the 1980s, including the Regulatory Flexibility Act, Executive Orders 12291 and 12866, and the FDA Modernization Act. Formal review processes involve retrospective assessments of existing regulations to ensure they remain relevant, incorporate new data, technology, and policies, and engage the public through Citizen Petitions and a unified agenda for transparent commentary.

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FDA's Framework for Regulation Review: Ensuring Modernized and Effective Policies

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  1. FDA’s Framework for Reviewing Regulations Leslie Kux Acting Assistant Commissioner for Policy U.S. Food and Drug Administration March 10, 2011

  2. Backdrop • 1980's • The Regulatory Flexibility Act • EO 12291 • 1990's • EO 12866 • REGO • FDA Modernization Act

  3. Formal Review Mechanisms: Final Rules • Retrospective Review of Selected Regulations • Usually due to changed circumstances, e.g., out-dated, statutory revisions, harmonization • Review When Revisions Made to Existing Rules • Is the specific regulation still valid, or should it be updated to reflect new policies, data, or technology

  4. Formal Review Mechanisms: Final Rules • Citizen Petition Process • 21 CFR 10.30 • 610(c) Review Required by RFA • FDA uses Unified Agenda to notify public of upcoming reviews and solicit comment • Letters to Small Business Community

  5. Formal Review Mechanisms: NPRMs and ANPRMs • Periodic Review to Determine if Withdrawal Appropriate • Current policy is every 5 years (2008; 2003;1994;1991) • Publish Notice in FR of candidate rules all NPRMs and ANPRMs published more than 5 years ago

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