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FDA Should Give Oral Presentations at All Advisory Committee Meetings, Public Citizen Tells Agency

June 21, 2007

FDA Should Give Oral Presentations at All Advisory Committee Meetings, Public Citizen Tells Agency

Current Meetings Often Lack FDA Expert Testimony, Petition Says

WASHINGTON, D.C. – Agency experts should be required to give presentations at all future Food and Drug Administration (FDA) advisory committee meetings discussing specific products, Public Citizen said in a petition filed today.

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 FDA. 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.

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.

“In our research, we found that the FDA did not present at 18 percent of advisory committee meetings that occurred from 1997 through 2006,” said Dr. Peter Lurie, deputy director of the Health Research Group at Public Citizen and an author of the petition. “Drug sponsors have made their case at every meeting but one, while the agency frequently has abdicated its obligation to provide an objective view of the data.”

For example, on May 17, 2006, the Peripheral and Central Nervous System Drug Advisory Committee met to review Novartis’ application to add an indication for its drug rivastigmine (Exelon) for the treatment of dementia associated with Parkinson’s disease. In its briefing documents submitted prior to the meeting, the FDA identified serious flaws in the Novartis application. The company failed to demonstrate that the dementia associated with Parkinson’s disease was clearly defined or that it could be clinically evaluated as a distinct form of dementia. Novartis also could not prove that rivastigmine had any clinically meaningful benefit and did not replicate its findings.

“Had the FDA made an oral presentation on rivastigmine to counter Novartis’s biased sponsor presentation, committee members might have paid more attention to the problems with the company’s application,” said Lurie. The committee voted in Novartis’ favor, and the FDA later approved the new indication for rivastigmine.

The Federal Advisory Committee Act of 1972 orders agencies to make certain that advisory committees are not improperly influenced by special interests so that the recommendations they give are independent and impartial.

“An advisory committee cannot make an ‘independent judgment’ if committee members are poorly and selectively informed and thus likely to be more familiar with the drug sponsor’s point of view than that of the FDA,” the petition concludes. “That committee members hear from the FDA is critical, for it is the FDA, not self-interested drug companies, that is entrusted with protecting the public.”

To read the petition sent to the FDA, click here.