FDA Approves Non-Drug Treatments More Quickly than Drugs

In 2007 the FDA performed a thorough review and approved 27 medical devices and non-drug treatments, out of 41 applications for which a decision was reached.  Yet, during the same time period, 3,052 new applications were deemed "substantially equivalent" to existing technology and given only a cursory review – of which 2,640 were approved.  [See New York Times article.]

However, for drug therapies, the FDA's approval process is much slower. Before approving medications, the FDA requires they go through extensive trials involving thousands of people, over many years before patients have access to promising new drug therapies, and the process can cost upwards of a billion dollars.

It appears the model the FDA follows to fast track most medical devices is superior to the way the FDA currently evaluates new drug therapies. 

Comments (3)

Trackback URL | Comments RSS Feed

  1. Ken says:

    Has anyone done a study of how many people die because the FDA delays the approval of new drugs?

  2. Greg says:

    Ken, Sam Peltzman did the original study of this. I’m not sure if there is something more recent.

  3. Joe S. says:

    More evidence that the FDA is keeping us from having access to life saving drugs. On the potential benefits of more access just look at the Lichtenberg study, summarized a few posts below.