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 goal now is to have that process “conducted in an open, transparent way so people will have confidence and the appropriate trust,” the FDA’s commissioner, Dr. Andrew von Eschenbach, told reporters.
The proposed rules will be open for public comment for 60 days before the FDA makes a decision whether to revise or adopt them.
The moves come amid increasing pressure from Congress to make the FDA decision-making process more open. In recent months, congressional committees have investigated the agency’s handling of safety concerns with the diabetes drug Avandia and the antibiotic Ketek. Some Democrats have called on the FDA to bar scientists with potential conflicts from the review panels.
The FDA says a ban on all outside reviewers with potential conflicts is impractical because so many scientists whose expertise the government relies on have ties to industries under FDA regulation. The agency routinely grants waivers for experts to participate and vote in advisory committee meetings. The FDA often cites cases where advisers either work for universities that have received industry support or supervise others who have.
The FDA is not required to follow the recommendations of such outside advisers but usually does.
In 2006, a study found that more than one-fourth of the experts relied on for advice on drugs, including whether to approve new pharmaceuticals, has a financial conflict.
But only 1 percent of these reviewers were excluded from serving on FDA advisory panels because of those conflicts, which can include tens of thousands of dollars in corporate grants, contracts and consulting fees, according to the study by the consumer advocacy group Public Citizen.
