"FDA should give oral presentatins at advisory c'tee meetings," says Public Citizen

Agency experts should be required to give presentations at all future US Food and Drug Administration advisory committee meetings discussing specific products, the consumer body Public Citizen said in a petition.

In a study published by the medical journal The Lancet in December 2006, Public Citizen reported that 49 of 275 public meetings of the FDA's human drug advisory committees that reviewed drug product applications between 1997 and 2006 did not include an oral presentation on the product by the agency. Because a drug or product's sponsor cannot be relied upon to present unbiased information, advisory committee members can be left with a one-sided oral presentation on which to base significant public health recommendations, it claims.

Public Citizen's petition calls on the FDA to require that all future advisory committee meetings include an oral scientific presentation by FDA staff on the products reviewed, including a thorough safety and efficacy assessment. Currently, advisory committee members receive briefing materials from both the drug sponsor and the agency before the meeting, but there is no guarantee that they will evaluate the hundreds of pages of information in detail, the petition argues.