Drug, Device Makers Must Disclose Payments to Docs
PHOTO: The FDA may have to be more selective about the doctors chosen to serve on its advisory committees to evaluate drugs and medical devices. Courtesy of POGO.
February 11, 2013
The Food and Drug Administration has just announced it's looking for dozens of doctors to serve on advisory committees that evaluate new medical devices before they hit the market. But the agency is also operating under new rules that could make it harder to fill those vacancies. The Affordable Care Act requires drug companies and medical device makers to publicly disclose payments they make to doctors and hospitals.
Dr. Ned Feder, staff scientist with the Project On Government Oversight, said it's part of a trend to bring more transparency to the health-care industry.
"When you ask one of these people, 'Is this affecting your vote?' the answer is invariably, 'No, it's not, of course not; I'm giving you my best expert advice,'" he said. "But we want you at the very least to disclose it, and in many cases, you can't serve on the committee if you have a conflict of interest."
Feder says doctors already have to discuss potential conflicts of interest with the FDA, but the information is not disclosed, even to other committee members. The doctor-payment details are being compiled by the Secretary of Health and Human Services and should be available to the public next year.
This issue made headlines most recently when the birth control pill called Yaz was taken off the market. Some FDA committee members who approved it had financial ties to either Bayer, the original manufacturer, or to the company that made the drug's generic equivalent.
Feder says doctor payments range from a few hundred dollars to tens of thousands.
"It's hard to imagine that a person receiving this kind of payment will maintain complete objectivity over the value of the drug, its safety and its effectiveness," he added.
Critics of the new disclosure requirement say it will slow the approval of new medical breakthroughs, and that payments aren't payoffs, but legitimate fees for speaking, consulting or testing drugs and devices.
Feder says the goal of the new disclosure rule isn't to keep doctors off committees, but to ensure that potential conflicts are more transparent.