Monday, February 23, 2009

Environmental attorney Sanders says GAO report warns that FDA is at high risk of failure in overseeing medical devices and pharmaceutical products.

The Government Accountability Office issued a report that warns that the FDA is a "high-risk" agency in the federal government. According to the GAO, the FDA is at high risk due to globalization, complex products and laws. As a result, FDA may be ill suited to ensure the safety of pharmaceuticals, biologic drugs, and medical devices.

That essentially means a large number of the American public may be at a substantial risk of harm from unsafe and ineffective medical products, including unsafe drugs and defective medical devices. And you thought the FDA was only failing at inspecting our food supply.

But don't worry about the manufacturers of such defective medical products, the federal courts are quick to protect the manufacturers from injured victims via federal pre-emption. That means, no redress of harm by manufacturers of defective dangerous medical productions in the America's tort system because the FDA is watching your back.

I encourage each of you to read through the GAO’s report on the FDA. The highlights of GAO's report is at http://www.gao.gov/highlights/d09271high.pdf.