Drug, Device Makers Must Disclose Payments to DocsAudio, Slider Monday, February 11th, 2013 Would you like to receive e-mail alerts when we have breaking news? Click here!
CHARLESTON, W.Va. – The U.S. Food and Drug Administration (FDA) has announced it is seeking dozens of doctors to serve on advisory committees that evaluate new medical devices before they hit the market. However, the agency is 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, a staff scientist with the Project On Government Oversight (POGO), said it is part of a trend to bring more transparency to the health-care industry.
“When you ask one of these people [receiving payments], ‘Is this affecting your vote?’ the answer is invariably, ‘No, it’s not, of course not – I’m giving you my best expert advice,’” Feder said. “We want them at the very least to disclose it, and in many cases, they can’t serve on the committee if they 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 known as “Yaz” was taken off the market. Some FDA committee members who approved it had financial ties to either Bayer or the company that made the drug’s generic equivalent.
Doctor payments range from a few hundred dollars to tens of thousands, Feder said.
“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 said it will slow the approval of new medical breakthroughs, and that payments are not “payoffs,” but legitimate fees for speaking, consulting or testing drugs and devices. Feder said the goal of the new disclosure rule is not to keep doctors off committees, but to ensure that potential conflicts are more transparent.