A report released by the Department of Health and Human Services found that the FDA doesn't always follow up on the status of marketed drugs. Post-approval studies are used to determine the long-term effects and unanticipated complications from a drug, and almost half of the drugs approved between 1994 and 2004 were required to conduct at least one postmarketing study. But HHS noted that of the 336 annual reports due in 2004, 35 percent were missing or contained no useful data. Additionally, the FDA reviewed only about 30 percent of the reports that were filed. The HHS's report concluded that postmarketing vigilance was not high on the list of the FDA's priorities. In response, FDA acting commissioner Andrew von Eschenbach said, "While we embrace several recommendations for improvement that are outlined in the report, we do not agree that FDA cannot readily identify whether or how timely postmarketing study commitments are progressing."
In the wake of the Vioxx debacle, postmarketing vigilance has taken on a new importance. If the HHS' investigation is accurate, such lapses have serious implications and could leave the door open for another major safety failure.
- read this Forbes report for more