Physicians sit on the Food and Drug Administration's panel for device clearances, and some of those physicians have financial ties to device companies. Does that influence their decisions?
A new report from Nasdaq shows a cardiologist who received $100,000 from medical device makers was on the review panel for a Boston Scientific device. The cardiologist advised for Boston Scientific, and the connection wasn't disclosed. Several physicians on FDA panels receive financial compensation from device companies for various services. Is that a problem?
Here are six quick facts from the report:
1. Among orthopedic, gynecology and cardiology devices reviewed over the past two years, there were 122 panel members evaluating devices and a third received compensation from device companies.
2. Around 10 percent of FDA advisors reportedly received "something of value" from companies whose products they evaluated.
3. There were only 1 percent of the corporate connections disclosed.
4. Most of the time, the FDA follows committee advice on approvals.
5. Under current policy, the FDA discloses financial interests "only when it has determined the experts need a waiver in order to serve," according to the report. Physicians who receive payments aren't excluded unless their work was related to the specific topic or product.
6. The FDA often has challenges obtaining "highly qualified" physicians to serve on the panel because it takes time away from the physician's practice.