FDA strengthens policy on vetting of advisers
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From: rpautrey2 on 8 Aug 2008 14:26 FDA strengthens policy on vetting of advisers Bernadette Tansey, Chronicle Staff Writer Tuesday, August 5, 2008 The Food and Drug Administration said Monday that it will look more closely at conflicts of interest when screening potential members of the influential expert committees that advise the agency on the approval of drugs. Appointments to the powerful committees, whose recommendations are usually followed by the FDA, have come under fire in recent years as Congress and watchdog groups scrutinized the agency after the withdrawal of the painkiller Vioxx in 2004. The consumer group Public Citizen found in a 2006 study that in 73 percent of the committee meetings from 2001 to 2004, at least one member had a financial conflict such as a grant from the drug company seeking approval of a new medicine. Some of the voting members' grants or consulting fees exceeded $100,000. Reacting to public pressure and new congressional requirements, the FDA issued four final guidance documents designed to limit bias on the committees and open their procedures to public examination. Consultants with a financial stake of more than $50,000 in all companies that could be affected by the outcome of an advisory board vote will, in general, not be allowed to participate. Advisers with stock, grants or other financial interests amounting to less than $50,000 may be allowed to attend meetings and vote if their expertise is deemed essential, and if the FDA grants a waiver. The rationale for the waiver, and the expert's personal financial stake would be posted on the FDA's Web site before the meeting. "It's imperative that we seek advice from independent experts, and that we do so in a way that is public, open and transparent," said Randall Lutter, FDA deputy commissioner for policy. Dr. Sidney Wolfe, director of Public Citizen health research group, said the new rules are weaker than the draft guidelines FDA released for discussion more than a year ago. Under those proposals, experts with conflicts of up to $50,000 would have been permitted to attend committee meetings, but not to vote. Wolfe said the new guidelines are somewhat better than FDA's past practices. "The whole underlying thought is that money talks," he said. "It is at least possible, though it's not certain, that it'll affect their vote." FDA senior policy adviser Jill Warner said the agency has been canvassing professional organizations and conducting other outreach measures to recruit independent experts. But finding advisers without ties to industry can be a challenge, she said. "To develop innovative products, industry relies on the same experts," she said. Warner said the new guidelines are more stringent than required by current law. Advisers would be disqualified from participating on a committee under certain conditions even if their financial stake did not reach $50,000. Experts would be ruled out, for example, if they served as principal investigators on a clinical trial of the product submitted to FDA for approval. They would also be disqualified if they led a clinical trial on a competing product. E-mail Bernadette Tansey at btansey(a)sfchronicle.com. http://sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/08/05/BUMI124S2O.DTL This article appeared on page D - 1 of the San Francisco Chronicle © 2008 Hearst Communications Inc. http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/08/04/BUMI124S2O.DTL |