FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 22-23, 2008

1. FDA Advisory Committee for Pharmaceutical Science and Clinical PharmacologyJuly 22-23, 2008 Introduction and Update Helen N. Winkle Director, Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration

2. Welcome • Ken Morris – chair of advisory committee • Returning members and SGEs • New members • FDA staff • Interested participants

3. What’s New in CDER? • Scientific Challenges and Skepticism • Various Initiatives affecting CDER

4. Exciting and Challenging Times in OPS • Made progress • Implemented concepts to improve quality – new CMC review paradigm (QbD) • Modernized our science base for generic drug approval • Improved capability to meet the demand for generic drugs • International harmonization • But… • More post approval actions required • Vulnerabilities in drug safety program • Growing skepticism about generic drugs • Still determining if science sufficient to have follow-on biologics • Must deal with new dosage forms and new technologies • Need for adequate training to meet growing requirements and changing processes

5. Initiatives and Other Activities Affecting Programs in OPS • Continuing • Pharmaceutical Quality for the 21st Century Initiative • Critical Path Initiative • PDUFA • New • Science Board Report • IOM Report • Safety First/ Safe Use • FDAAA

6. General Purpose of Initiatives and Activities as Relate to CDER • Ensure adequate scientific support for ensuring safety, efficacy and quality of marketed products • Provide scientific and technical methods to improve predictability and efficiency to better develop and manufacture drug products • Facilitate adoption of quality management techniques in regulatory processes • Implement risk-based approaches to product regulation • Enhance postmarket authorities to better ensure product safety – maintain focus on drugs once they are on the market • Improve upon professional culture • Prepare scientific and regulatory processes for future – including understanding new technologies and preparing for different ways of developing drugs (e.g., novel dosage forms) • Ensure adequate resources

7. Role of Advisory Committee • Advisory committee purpose is basically to promote a better FDA and industry understanding of the unique challenges in the present and future healthcare environment • Committee’s role is to provide scientific advice in order to help FDA in responding to these challenges • Science Board Report of 2007: • “…science at FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current emerging regulatory responsibilities.” • Collaboration necessary through advisory committee is a must

8. Agenda – 1st Day • Nanotechnology • Brought before committee before as an awareness topic • Issued Agency report in Fall 2007 – need for regulation throughout FDA • Still need to determine how best to regulate in CDER and what we need to focus on to ensure safety of products containing nanoparticles • Lead in Pharmaceutical Products • National focus on all products containing lead • Ensuring focus on pharmaceutical products as well – need to be prepared and informed • Need to ensure appropriate regulatory framework

9. Agenda – Day 2 • Bioequivalence for Locally Acting Drugs that Treat Gastrointestinal Conditions • Need to ensure using most scientific bioequivalence methodology • Drug Classification of Orally Disintegrating Tablets • Nomenclature and consistency issue • Use of Inhaled Corticosteriod Dose Reponses as a Means to Establish Bioequivalence of Inhalation Drug Products • Need to ensure using most scientific bioequivalence methodology