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FDA Regulation of Drug Quality: New Challenges

FDA Regulation of Drug Quality: New Challenges. Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research, Food and Drug Administration November 16, 2001. Regulation of Drug Quality: Current Status. Pharmaceutical industry manufacturing sector highly regulated

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FDA Regulation of Drug Quality: New Challenges

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  1. FDA Regulation of Drug Quality: New Challenges Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research, Food and Drug Administration November 16, 2001

  2. Regulation of Drug Quality: Current Status • Pharmaceutical industry manufacturing sector highly regulated • FDA review and approval of process, documentation, and facility required prior to approval • Many process changes require FDA review and approval prior to institution • Ongoing manufacturing subject to FDA inspection and GMP standards conformance

  3. Current Status of System for Ensuring Drug Quality • US Drug products are of high quality, BUT • Increasing trend toward manufacturing-related problems • Recalls • Disruption of manufacturing operations • Loss of availability of essential drugs • Negative impact on new drug approvals

  4. Current Status System for Ensuring Drug Quality, cont • US drug products are of high quality, BUT • Low manufacturing and QA process efficiency--cost implications • Innovation, modernization and adoption of new technologies slowed Introduction of new technologies in facilities not for US market

  5. Current Status System for Ensuring Drug Quality, cont • US Drug Products are of high quality, BUT • High burden on FDA resources • About 4,000 manufacturing supplements submitted yearly • FDA inspectors unable to meet statutory biennial GMP inspection requirement • Lower scrutiny of non-domestic industry

  6. How Did We Get Here? • System evolved beginning 30-40 years ago--when sectors of industry lacked rigorous SOPs • Science/technology base did not evolve as quickly as in other sectors

  7. How Did We Get Here? (CONT) • GMP standards are empirical, not science based • International conference on Harmonization--consensus based standards (1990’s) • Industry--regulatory risk averse

  8. The Discovery-Development-Manufacturing Challenge • The drug discovery revolution • identification of promising new molecular entities for development is not “rate-limiting” • Significant ongoing efforts to improve drug development processes • minimize high attrition rates • Need for innovation in manufacturing process R&D • significant, long-term, impact on public health and industry

  9. Challenges for FDA • How to encourage innovation while ensuring high quality • Successful adoption of new technologies will IMPROVE overall quality • How to successfully shift from empirical to science based standards for manufacturing process quality

  10. Challenges for FDA • How to decrease reliance on pre-approval review and physical evaluation • How to recruit and train a scientific workforce proficient in application of new technologies

  11. Today’s Approach • Presentation of Problem from variety of perspectives • Use of PAT as an EXAMPLE of new technology

  12. Speakers • Doug Dean and Frances Bruttin (PricewaterhouseCoopers, Pharmaceutical Sector Team) • G. K. Raju (Executive Director, MIT’s Pharmaceutical Manufacturing Initiative) • Norman Winskills (Vice President Global Manufacturing Services, Pfizer) and Steve Hammond (Manager, Process Analytical Support Group, Pfizer) • Ajaz Hussain (FDA Deputy Director, Office of Pharmaceutical Science) - Regulatory perspective on new scientific approaches

  13. Questions for the Science Board • Are you able to support the approach? • What resources do you suggest FDA draw on? • Are there additional aspects to regulation of pharmaceutic quality that we should focus on?

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