Industry ties to doctors and other health experts who serve on Food and Drug Administration advisory panels would be disclosed in more detail under guidelines the agency is developing.
FDA Deputy Commissioner Scott Gottlieb said Monday the draft guidelines would also provide more information about which conflicts are eligible for an agency waiver allowing panelists to participate.
The advisory committees, composed mostly of doctors and researchers who offer opinions on whether drugs and devices should be approved, have come under scrutiny in recent years over some panelists’ ties to manufacturers.
“We want to be more transparent, and specific, about these reasons, to the maximum extent possible, so people can better understand the relationships that we accommodate and our reasons for doing so,” Gottlieb said in prepared remarks for a discussion on government advisory panels later Monday.
The agency released the remarks ahead of the event, sponsored by the advocacy group Center for Science in the Public Interest (CSPI).
Twenty-three FDA advisory committees meet throughout the year to evaluate drugs and biologics, while another 21 evaluate devices. A handful of other panels weigh food, animal products and other areas. The FDA is not required to follow advisory panel recommendations but it usually does.
Potential conflicts of interest can range from stockholdings and research grants to speaker and consultant fees.
Pressure from Congress
Some critics, including editors of leading medical journals, argue that at the very least such ties give an appearance of a conflict and require doctors to disclose links when publishing articles. CSPI says no ties are acceptable.
Others say it is common practice for researchers to receive funding from industry, and many doctors have argued that it does not affect their judgments or practice of medicine.
“It is simply the case that top experts are going to sometimes have these kinds of relationships. In some cases ... we want these experts on our committees precisely because they have this experience,” Gottlieb said in his remarks.
Congress has gotten involved, last year requiring the FDA to publish which panelists have received a waiver 15 days before a committee meets.
In May, the House passed a measure banning any scientist with financial links to drug or device companies from serving on the FDA’s committees.
CSPI’s Merrill Goozner, who heads the group’s Integrity in Science Project, said the FDA was wrong to argue that only researchers who work for industry have expertise.
“There are people out there who conduct clinical trials ... but they do it on somebody else’s nickel,” he told Reuters. Those experts are harder to find, he added, but it can be done. It just takes a little while longer.”
