FDA’S LAX METHODOLOGY, PART 2

In my December 10 posting, I discussed how physicians are troubled by the FDA’s lax methodology in conducting clinical trial of drugs and medical devices. In today’s Torts Prof Blog , Bill Childs points out that today’s NY Times features an article by Gardiner Harris  entitled, “ F.D.A. Is Lax On Oversight During Trials, Inquiry Finds.”

The focus of today’s news is the FDA’s historic failure to address the financial conflicts  of doctors conducting clinical trials of drugs and medical devices.  Apparently, there are growing concerns that money accepted by doctors from drug and device makers “may hurt patients and skew studies,” according to Mr. Gardiner.

You may remember that in my January 9 posting, I noted that the New England Journal of Medicine had instituted a new policy to disclose financial conflicts of its physician-authors, news to which I was alerted by Gardiner Harris’s article in that day’s NY Times. 

I am hopeful that our President-Elect’s appointment of a new Surgeon General will help get the FDA back on track.  It would be nice to see that organization receive some press that did not reveal the existence of sloppy and potentially dangerous procedures.

In the meanwhile, it is outrageous that federal preemption remains available to protect drug and device companies whose products have been cleared by the FDA from lawsuits by victims of negligence in state courts.   When the FDA’s own clinical trials are suspect, the products that have passed clinical trials are suspect.  So it should not come as a shock that they might injure or kill an end user.  It is simply not fair to prevent a medical consumer who relied on the FDA’s “stamp of approval” from seeking redress in state court.  Stay tuned.