1 / 14

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

conroy
Download Presentation

FDA Regulation of Drug Quality: New Challenges

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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?

More Related