Healthy Skepticism Library item: 13486

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Lenzer J.
Longer, better studies of coronary stents are needed, FDA tells industry
BMJ 2008 Apr 5; 336:(7647):743
http://www.bmj.com/cgi/content/extract/336/7647/743

Abstract:

After a year of controversy over the relative safety of drug eluting stents and bare metal stents, the US Food and Drug Administration has issued guidance to the industry on the development and testing of stents.

It recommends that all clinical trials should have a follow-up period of 12 months, instead of the current nine months, and that a data monitoring committee should continuously review all studies of drug eluting stents. The agency, which issued the guidance last week, will accept public comments on the recommendations for 120 days before it issues its final guidance.

Daniel Schultz, director of the agency’s Center for Devices and Radiological Health, said that the draft guidance “is part of FDA’s ongoing effort to provide regulated industry with recommendations on measures that can minimise the risks while preserving for patients the benefits of drug eluting stents.”

The guidance comes in response to a fractious debate . . .