The Government Accountability Office today lambasted the FDA for failing to create a "clear and effective process" for managing post-market drug safety. The report was ordered by Senator Charles Grassley, who suggested that the FDA's seal of approval for drug safety isn't warranted. The report was requested in 2004 as the agency was reeling from revelations about its handling of the cardiovascular dangers of Vioxx and teen suicides linked to antidepressants.
The most immediate question raised by the report was whether the Office of Drug Safety will be removed from the Center for Drug Evaluation and Research, which also includes the Office of New Drugs. Critics have called for drug safety personnel to operate separately from the group responsible for drug review. The GAO didn't make any direct recommendations, but did call on the FDA commissioner to clarify the role. The report also recommended that Congress look at requiring post-marketing studies. Currently the studies are often agreed to and regularly ignored.
- here's the report [1] from USA Today for more information
Links:
[1] http://www.usatoday.com/news/health/2006-04-23-fda-safety_x.htm