With pressure mounting on the agency to revise its drug-review practices to ensure that new treatments are as safe as possible before hitting the market, the FDA announced it would look into how it chooses members for its panels and how it handles possible conflicts of interest among panelists in order to establish "best practices" for the process.
As part of its probe, the FDA said it would review the processes for nominating panel members, choosing consultants with expertise specific to the meeting topic, developing competing products lists, screening for conflict of interest and using special government employees outside of an advisory committee meeting.
The FDA's panels of medical experts hold a lot of sway in the agency's drug-approval decisions, with the agency following its panels' advice to approve or deny approval of a new drug in the vast majority of cases.
The agency typically goes to its panels for recommendations on new drug applications in cases where the agency is concerned about a particular safety signal in the application's clinical data or when the potential new treatment would be the first approved in a new drug class.
As scrutiny of the FDA's drug-safety gate-keeping mission has intensified, critics have raised concerns over the possible bias of panel members, many of whom have financial ties to drug companies. The agency's current panel system requires that panel members disclose such ties.
In fact, last month the Journal of the American Medical Association published a study by consumer advocacy group Public Citizen showing that at least one FDA panel member disclosed a conflict of interest -- such as a contract with a drug company or grant of more than $100,000 -- in 73 percent of the 221 advisory committee meetings held from Jan. 1, 2001, to Dec. 31, 2004.
Such conflicts "have a small but important association with voting behavior," said Peter Lurie, the study's lead author and deputy director of Public Citizen's Health Research Group.
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