Meeting

Concerns about the ability of the FDA 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).

Substantial changes have occurred in the drug regulatory environment since these proposals were put forth. 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. The first meeting focuses on personalized medicine and the genetic basis of adverse events. The second meeting (date to be determined) will address post-market safety science. The third (date to be determined) will consider pre-market safety science. 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.