FDA: Absent for Many Drug Committee Hearings
Public Citizen, a non-profit public interest organization, has petitioned the U.S. Food and Drug Administration (FDA) to give oral presentations at all advisory committee meetings that involve the presentation of specific products. According to a recent article published in The Lancet, of the 275 public meetings of the FDA's Human Drug Advisory Committee occurring between 1997 and 2006, 49 included no oral scientific presentation by the agency. In contrast, drug company representatives made presentations at every meeting but one.
Among those meetings lacking an oral presentation by the FDA was a May 17, 2006, meeting of the Peripheral and Central Nervous System Drug Advisory Committee, where an application by Novartis was made to add a clinical indication to its drug rivastigmine (Exelon). The manufacturer sought the approval of its drug to treat the dementia associated with Parkinson's Disease. Briefing documents submitted prior to the meeting were found by the FDA to contain serious flaws, including a failure to demonstrate that the dementia associated with Parkinson's Disease could be clinically evaluated as a distinct kind of dementia. Ultimately, however, the review committee found in favor of Novartis, granting the new clinical indication for its drug, after the FDA made no oral presentation of its concerns at the meeting.
According to Public Citizen, advisory committees can not be expected to make independent judgments on prescription drug matters if they hear testimony exclusively from pharmaceutical manufacturers, and not from the FDA, the agency charged with protecting the public interest.
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