1. 1 Estimating CDER Resources Devoted to Safety Theresa M. Mullin, Ph.D. Office of Planning, Office of Commissioner April 15, 2005 Presentation to: FDA Science Board Advisory Committee

2. 2 Background of Internal Study to Quantify Extent of Drug Safety Effort Public discussion about drug safety based on: –Sense of urgency –Perceived imbalance in Center resources and attention devoted to "safety", based on –Limited data and limited set of perspectives reported by media Resource/budget figures available by office/program component [e.g., CDER, PDUFA, ODS], not by safety activity Full extent of FDA responsibility -- and attention -- to drug safety not accounted for

3. 3 Limited Information on Resources Devoted to Drug Safety Most readily available resource numbers were budget figures for CDER offices, not CDER safety activities –"This year, the safety office received less than $24 million of CDER's budget of almost $500 million" Washington Post, Nov. 18, 2004 Reports suggested limited understanding of CDER drug safety work, including pre-market review –"FDA and industry have gotten very successful at getting drugs to the market based on their efficacy...Safety has become a stepchild to the agency and the process" Washington Post, Nov. 18, 2004 –"Currently, the drug-review divisions generally oversee labeling and other decisions even after the medicines go on the market, with the drug safety office in an advisory role." Wall Street Journal, Nov. 19, 2004

4. 4 Goal: Provide More Complete Account Questions to Address –What activities are considered part of FDA’s “drug safety” efforts? –What level of effort does FDA devote to drug safety? –How much of FDA’s drug safety efforts are spent on pre- vs. post-market activities? Challenges –Analysis of safety incorporated into nearly all parts of CDER; not one office or one job function. –Time reporting data follows stages of review and monitoring in drug development; safety work cuts across these stages

5. 5 Overall Approach Select a sample of experts representing key offices and job functions Elicit individual expert’s estimate of percent of work time spent on safety-related activities Use time reporting data to extrapolate individual percentages to other technical staff to estimate percent safety effort for each office Use time-weighted averages to combine estimates from each office to estimate CDER percentage Form Study Team including OC/OPL and CDER/OM

6. 6 Offices and Job Functions for Sampling Frame Office of –New Drugs –Pharmaceutical Science –Pharmacoepidemiology and Statistical Science –Clinical Pharmacology and Biopharmaceutics –Compliance –Medical Policy –Executive Programs Job Function – Medical Officer – Consumer Safety Officer – Chemist/Chemical Engineer – General Health Scientist – Pharmacologist/Toxicology – Pharmacist – Mathematical Statistician – Public Health Program Specialist – Microbiologist

7. 7 Study Method Develop Multi-Attribute Model –Time reporting data 400 categories with pre-and post-market distinction Four-week reporting period; 100% reporting among technical staff –Used professional judgment to aggregate time-reporting categories, so as to Ensure meaningful bins for safety activities Maintain pre- and post-market distinction Account for “overhead” activities separately Conduct Formal Interviews –Followed Stanford/SRI principles for expert elicitation –Conducted 51 interviews –across offices and job functions-- using team of interviewers Use FY 2004 budget actual data

8. 8 Data Entry Table – p. 1

9. 9 Data Entry Table – p. 2

10. 10 Results: Level of Effort Devoted to Drug Safety in CDER in 2004 Percent of Work Time Spent on Pre-market Safety Activities Percent of Work Time Spent on Post-market Safety Activities Total Percent of Work Time Spent on Safety 32%18%50%

11. 11

12. 12 Estimated CDER FTEs Devoted to Drug Safety vs. Total FDA FTEs FDA Program AreaFY 2004 Actual – Total FTEs CFSAN910 CDER Drug Safety Activities 2,190 1,093 CBER797 CVM349 CDRH1,061 NCTR207 ORA3,872 Other Activities755 TOTAL10,141

13. 13 Conclusion Assuring drug safety involves most CDER offices and scientific experts from a wide range of disciplines, in work that –Begins at the earliest stages of drug development, before early tests in humans –Continues through oversight of clinical trials and marketing application review –Includes post-marketing surveillance, risk management, epidemiologic research –Involves oversight of commercial manufacturing quality –Includes proper labeling and monitoring of appropriate product promotion –Overall, accounts for approximately 50% of CDER staff time