Senate Bill Would Streamline Medical Device Approval

When it comes to approving medical devices for patients to use, the Food and Drug Administration is handcuffed by conflict of interest rules that it says slow the process. A bipartisan trio of senators have introduced a bill that would ease the rules in favor of getting devices approved quicker, possibly at the expense of medical ethics.

Reuters reports the bill would counteract a 2007 law that stopped advisory panelists with ties to either the companies that manufacture the devices or their competitors from serving without waivers. The FDA said the law makes it difficult to find experts to fill out its panels, hurting patients by holding beneficial devices in limbo.

According to the senators, the new legislation would hold expert panelists to similar requirements in other areas of the federal government. A like-minded law is said to be in the works in the House of Representatives.

Skeptics, which include patients and consumer advocates, say the legislation is unnecessary because the FDA isn’t looking hard enough for experts and doesn’t use up its allotment of waivers.

Senators propose relaxing FDA conflict rules [Reuters]