Wednesday, April 22, 2009

Medical Devices and the FDA

It is not unusual to see pharmaceutical companies under investigation for dubious practices--like obscuring data from clinical trials or outrageous marketing tactics. But in recent years, the US Food and Drug Administration has also been under the gun. 

Now, the issue is about the approval of certain medical devices. From an article in the NYT:
Nine dissident scientists signed letters to President Obama and others in the administration charging that agency officials had acted illegally and that patients were routinely put at risk by medical devices approved for sale despite significant and often unanimous objections from scientific reviewers.
The FDA will have a chance to defend itself, but these kind of news affect the public's perception of the agency and in turn, it affects medical writers, who are in the midst of the controversy. 

I wonder what circumstances surrounded the development of the regulatory documents submitted for the approval of these medical devices. Were the medical writers responsible for these documents aware of the reviewers' objections or not? 

Maybe the objections were clear in the documentation submitted but the FDA approved the devices anyway (we don't know the details). 

We'll see what comes out of this after the meeting and will know more details if the Institute of Medicine gets involved as the NYT article suggests.

1 comment:

Anonymous said...

The Times article was just the latest in a string of outrageous FDA stories. Check out this blog's reaction to it. ( God help us if the Medical Device Act doesn't pass and the FDA is allowed to have the final word on device safety.