My Photo
Name:
Location: Red Bank, NJ

I have dedicated my law practice for the last 25 years to the wrongfully injured and their families. The purpose of this blog is not to provide legal advice. If you need legal help you can contact me at cplacitella@cprlaw.com or visit our website at www.cprlaw.com. Thank You

Wednesday, August 30, 2006

Federal judge throws out third-party Payor claim claiming preemption


The FDA is not competent to monitor the safety of drugs in the marketplace. The GAO wrote a clear and concise report reaching this and other conclusions in 2006. If FDA has inadequate resources and authority to ensure safety of drugs in the marketplace, because they cannot truly appreciate the evolving risks, then how can the FDA possibly be the final arbiter of an appropriate label? Not possible.
The preamble assumes the FDA actually knows what should be on product labels. The reality according to the GAO is much different.
FDA, by the way, agreed with the conclusions of the GAO, calling them reasonable. But FDA has had no comment, far as I know, about the GAO's recommendations for improving the system.

0 Comments:

Post a Comment

Links to this post:

Create a Link

<< Home