# Presentation: 410962

## FDA Science Board

**Introduction to Drug Safety**
- April 15, 2005
- Rockville, MD

*RADM Steven Galson, MD, MPH*
*Acting Director, Center for Drug Evaluation and Research*
*Food and Drug Administration*

## Drug Safety Policy Environment has Become More Contentious

- Risks of SSRI Antidepressants
- Withdrawals of COX-2 analgesics
- Allegations – FDA doesn’t care about drug safety
- Numerous Congressional oversight investigations and hearings: Drs. Woodcock and Kweder testimony
- Press Focus – has evolved towards more nuanced approach

- FDA SCIENCE BOARD

- April 15, 2005

## Slide 3

- FDA SCIENCE BOARD

- April 15, 2005

## The Drug Approval Pendulum 

**By Anne Applebaum/Washington Post **
**Wednesday, April 13, 2005; Page A17 **
- "It just breaks my heart when I think of American citizens having to go to Switzerland or Mexico to get the drugs and devices they need to stay alive because the Washington bureaucracy won't approve them."
- -- Rep. Thomas Bliley (R-Va.), 1995
- "When the FDA approves a drug, it should be a Good Housekeeping seal of approval. . . . Consumers shouldn't have to second-guess the safety of what's in their medicine cabinet."
- -- Sen. Chuck Grassley (R-Iowa), 2005

- FDA SCIENCE BOARD

- April 15, 2005

## Drug Safety Overview

- Drug Safety Top Priority Across Regulatory Programs - not just post-marketing surveillance
- New drugs
- Manufacturing/regulation of drug quality
- Generic drugs
- Regulation of clinical trials and promotional activities
- Pre-market safety evaluation based on mandate of Food, Drug & Cosmetic Act:  “All tests reasonably applicable” to safety

- FDA SCIENCE BOARD

- April 15, 2005

## Drug Safety Overview cont’d

- Implementation- Regulations:  Information that “the product is safe...for recommended use.”
- Series of FDA & International guidance documents spell out level of evidence needed for safety evaluation:  _science_ plus _judgment_ plus _policy_
- Lots of room for disagreement
- How safe is safe?
- Risk/benefit individual for each drug or class (no formula)
- Innovation & new products vs. more assurance of safety

- FDA SCIENCE BOARD

- April 15, 2005

## Have user fees modified how we balance benefit and risk?

- Withdrawal rate and black box warning analyses – NO EVIDENCE

## Slide 8

- FDA SCIENCE BOARD

- April 15, 2005

## Have Data Requirements Changed?

- Yes! More data submitted to support applications than ever before.
- Conclusion: Drug Supply safer than ever before, BUT
- There are issues:
- Science has moved ahead more with efficacy than safety analysis
- Bulk of studies conducted have as their main focus efficacy

- FDA SCIENCE BOARD

- April 15, 2005

## Safety Issues

- Science has moved ahead more with efficacy than safety analysis – doing same tox tests
- Size of premarket safety database determined by need of efficacy studies
- Rare or time-dependent effects not known at approval
- Cannot require additional safety studies after approval. Can only move to take drugs off market

- FDA SCIENCE BOARD

- April 15, 2005

## Safety issues – continued	

- Major additions to pre-approval safety database would be two-edged sword
- No national pharmacovigilance system

- FDA SCIENCE BOARD

- April 15, 2005

## Plan for this Morning

- Pre-Market Drug Safety:
- 	Armando Oliva, M.D.
- Labeling and Electronic Initiatives:
- 	Rachel Behrman, M.D., MPH
- Drug Safety Initiatives:
- 	Steven Galson, M.D., MPH
- Post-Market Drug Safety:
- 	Paul Seligman, M.D., MPH
- Drug Safety Resources:
- 	Theresa Mullin, Ph.D.
- Applying New Science to Drug Safety:
- 	Janet Woodcock, M.D.
- Committee Questions and Discussion

- FDA SCIENCE BOARD

- April 15, 2005