WASHINGTON (AP) The Food and Drug Administration announced proposed rules Thursday to reduce potential conflicts of interest among outside experts who advise the government on approval of drugs and other regulated products. The experts would have to disclose any financial ties to the industry under review.
Experts on the advisory committees would have to fill out a form disclosing the potential conflicts and explaining why they should still be able to advise the agency. If the FDA agrees to a waiver, the disclosure form would be posted on the FDA's Web site, typically at least 15 days before the committee meets.
Under the current system, outside advisers disclose potential conflicts to the FDA. The agency may grant a waiver if it is deemed in the best interest of the advisory process to have the expert's input. The FDA then announces when waivers are granted but does not routinely release the disclosure documents.
The proposed rules will be open for public comment for 60 days before the FDA makes a decision whether to revise or adopt them.