FDA rolls out new conflict rules

The Food and Drug Administration linkurl:unveiled;http://www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html new, tougher linkurl:conflict of interest;http://www.the-scientist.com/news/display/24056/ rules yesterday (Aug 4). Key among the regulations was one that linkurl:prohibits;http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACWaiverCriteriaFINALGuidance080408.pdf physicians or researchers who have more than $50,000 worth of financial interests in pharmaceutical or medical device companies from

Bob Grant
Bob Grant

Bob Grant is Editor in Chief of The Scientist, where he started in 2007 as a Staff Writer.

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Aug 4, 2008
The Food and Drug Administration linkurl:unveiled;http://www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html new, tougher linkurl:conflict of interest;http://www.the-scientist.com/news/display/24056/ rules yesterday (Aug 4). Key among the regulations was one that linkurl:prohibits;http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACWaiverCriteriaFINALGuidance080408.pdf physicians or researchers who have more than $50,000 worth of financial interests in pharmaceutical or medical device companies from offering expert advice as members of linkurl:FDA advisory panels.;http://www.the-scientist.com/blog/display/53953/ The new rules, issued in one draft guidance and four final guidance documents, also state that the FDA will linkurl:publically release;http://www.fda.gov/oc/advisory/GuidancePolicyRegs/AC48HourFINALGuidance080408.pdf briefing materials pertaining to advisory committee meetings no later than 48 hours before the meeting occurs, and that votes taken at these meetings will occur linkurl:simultaneously;http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACVotingFINALGuidance080408.pdf rather than sequentially, avoiding the potential for one vote to affect the next. The FDA also claims to have made its linkurl:Web site;http://www.fda.gov/ more navigable so that the public can easily access information relating to advisory panels. "It's imperative that we seek advice from independent experts, and that we do so in...
://www.the-scientist.com/news/display/24056/ rules yesterday (Aug 4). Key among the regulations was one that linkurl:prohibits;http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACWaiverCriteriaFINALGuidance080408.pdf physicians or researchers who have more than $50,000 worth of financial interests in pharmaceutical or medical device companies from offering expert advice as members of linkurl:FDA advisory panels.;http://www.the-scientist.com/blog/display/53953/ The new rules, issued in one draft guidance and four final guidance documents, also state that the FDA will linkurl:publically release;http://www.fda.gov/oc/advisory/GuidancePolicyRegs/AC48HourFINALGuidance080408.pdf briefing materials pertaining to advisory committee meetings no later than 48 hours before the meeting occurs, and that votes taken at these meetings will occur linkurl:simultaneously;http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACVotingFINALGuidance080408.pdf rather than sequentially, avoiding the potential for one vote to affect the next. The FDA also claims to have made its linkurl:Web site;http://www.fda.gov/ more navigable so that the public can easily access information relating to advisory panels. "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's deputy commissioner for policy, in a linkurl:statement;http://www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html from the agency. "Today's announcement strengthens our processes." The guidances were issued in response to a linkurl:law;http://www.fda.gov/oc/initiatives/HR3580.pdf that, in part, required the FDA to progressively cut back on the number of conflict of interest waivers it issues to advisory panel members who report financial interests but posses "essential expertise." The current rules do allow for such waivers to be granted for potential panel members who report less than $50,000 in pertinent financial interests. linkurl:Merrill Goozner,;http://www.the-scientist.com/blog/display/54836/ director of the Integrity in Science Project at the research watchdog group Center for Science in the Public Interest, said that the new rules are a step in the right direction. "[The FDA is] eliminating people with gross conflicts of interest," he said. "That's a start." But Goozner said that while the new FDA conflict rules are welcomed, the agency can do more to address conflicts of interest and other issues surrounding drugs and health care such as post-market monitoring and comparative effectiveness research. "[The new conflict rules] establish some interesting precedents and we look forward to continuing to push [the FDA] to further toughen the rules," he said. "There's just a whole host of issues that get wrapped up into making our health care system more effective and efficient."

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