More than we asked for: Institute of Medicine reports on the FDA

November 1, 2006

Two years ago, when bad news about Vioxx (rofecoxib) hit the fan, the Food and Drug Administration (FDA) was roundly criticized for its failure to take sufficient account of studies showing that the drug carried cardiac risks. The FDA had to agree that something was amiss, and asked the Institute of Medicine (IOM) to undertake a study to determine what was wrong with the agency's drug approval process and what should be done to set things right.

Two years ago, when bad news about Vioxx (rofecoxib) hit the fan, the Food and Drug Administration (FDA) was roundly criticized for its failure to take sufficient account of studies showing that the drug carried cardiac risks. The FDA had to agree that something was amiss, and asked the Institute of Medicine (IOM) to undertake a study to determine what was wrong with the agency's drug approval process and what should be done to set things right.

Now the IOM Report is out-and it's a humdinger.

The fundamental problem at the FDA, according to the IOM committee that wrote the report, is the imbalance between the tightly regulated approval process for new drugs and surveillance that takes place after that approval-when drugs are aggressively marketed and come into widespread use. The initial approval process gets the lion's share of the agency's resources, with a very large percentage of funding coming from user fees paid by the pharmaceutical industry.

To that end, the committee makes a number of specific recommendations. Among them:

Download the report, The Future of Drug Safety, from the IOM at http://www.iom.edu/.