FDA's ineffective use of c'tees slammed

The US Food and Drug Administration is not using its own advisory committees effectively when considering new drug approvals, says a study from the consumer group Public Citizen, the results of which are published in a letter in the current issue of UK-based medical journal, The Lancet. These showed that the the FDA follows committee recommendations only 72% of the time and does not present its own reviews in 18% of cases.

Public Citizen said it found that the FDA often allows drug firms to make oral presentation without a countervailing FDA view and that only around 24% of New Molecular Entities approved between 2000 and June 30, 2006, were preceded by advisory committee meetings. Also, fewer such advisory panels are being convened now than was the case in the late 1990s, it stated.