FDA Introduces New Conflict of Interest RulesAug 6, 2008 | Parker Waichman LLP
The Food & Drug Administration (FDA) has finally taken steps to address potential conflicts of interests among members of its advisory panels. What remains to be seen is whether the FDA's new policies will effectively put an end to possible conflicts of interests caused by the financial ties advisers often have to the drug industry.
Advisory panel members are experts who advise the FDA on matters such as drug approvals and labeling changes. Recent scandals surrounding the misguided approvals of drugs like Vioxx have raised questions about the FDA advisers and the financial ties - such as a grant from the drug company seeking approval of a new medicine - some of them have to the drug industry.
In 2006, the consumer advocacy group Public Citizen published a study which found that at least one advisory panel member had a financial relationship with a drug company in 73 percent of the FDA advisory committee meetings held from 2001 to 2004. Some of the voting members' grants or consulting fees exceeded $100,000.
Critics of these financial arrangements argue that they could potentially influence the way an advisory panel member votes. Reacting to both congressional and public pressure, the FDA has issued four final guidance documents designed to limit bias on the committees and open their procedures to public examination.
Under the new rules, FDA advisers with a financial stake of more than $50,000 in all companies that could be affected by the outcome of an panel vote will, in most cases, 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 reason for the waiver, and the expert's personal financial stake would be posted on the FDA's Web site before the meeting.
Advisers would not be able to participate on a panel 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 a product their committee was considering for approval. They would also be disqualified if they led a clinical trial on a competing product.
Many FDA critics say the new rules don't go far enough to insure that all conflicts of interest are avoided. Dr. Sidney Wolfe, director of Public Citizen health research group, told the San Francisco Chronicle that 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.