Friday, April 15, 2011
On the FDA's failure to protect the public
In February, I wrote about a new report published in the Archives of Internal Medicine that concludes that 70% of all medical devices recalled since 2005 had been approved by the FDA through a controversial “fast-track” process, which only requires the manufacturer to provide minimal data on safety and effectiveness. Go here for that story and links. In a related story, it is being reported now that Federal analysts testified this week that the FDA is failing to protect the public from defective medical devices by allowing them on the market with little testing through an industry-exploited fast-track approval program. Go here for the full story. Go here for a recent post on this subject. Crticism of the FDA as an inefficient agancy are nothing new, of course. If you go to the right side panel of this blog and click on the FDA section you can scroll down for many older posts discussing past criticism on the process to approve drugs, the lack of proper supervision of the drug industry, the FDA's failure to take drugs off the market and so on. Here are a couple of recent posts on this subject: here and here.