Community Update: Improving The Science Of Drug Safety
- When:
- Wednesday, September 02, 2009 - Friday, October 02, 2009 (10:30 AM)
- Topic(s):
- Biomedical and Health Research, Public Health
- Activity:
- Forum on Drug Discovery, Development, and Translation
- Board(s):
- Board on Health Sciences Policy
Biomedical Science & Policy Discussion Series
A Three Part Series
When: September 2, 2009
Where: Reserve Officers Association - One Constitution Avenue, NE, Washington, DC
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COMMUNITY UPDATE: IMPROVING THE SCIENCE OF DRUG SAFETY
A three part meeting to discuss progress that has been made in safety science since the release of the IOM Drug Safety report and the 2007 FDAAA legislation.
Concerns about the FDA’s ability to ensure the safety of drugs grew in the 1990s and 2000s as a result of several adverse drug safety findings and high profile recalls. As a result, a number of studies were conducted to assess FDA’s drug review system and consider reforms. Concerns focused on several areas, including staffing and funding levels, FDA’s focus on premarket review, the system for monitoring postmarket data, authority to regulate drugs already on the market, and the capacity for adapting to the rapidly evolving molecular and genomic basis of drug development. Several major proposals for reform were put forth:
- The Institute of Medicine (IOM). The Future of Drug Safety (September 2006).
- The FDA response to the IOM report (February 2007).
- The Food and Drug Administration Amendments Act (FDAAA), enacted into law September 2007.
- The FDA Science Board. FDA Science and Mission at Risk (November 2007).
Since then, substantial changes have occurred in the drug regulatory environment. To examine these changes and consider the extent to which they address the concerns expressed in these proposals, the IOM is hosting a series of three meetings. In each meeting, experts in drug development and regulation will consider the changes that have occurred within and beyond the FDA, their potential for enhancing drug safety, and further improvements needed to ensure the safety of drugs.