Georgia Governor Proposal LInked To Medical Device Approval Which Was Slammed By GAO Report

The Governor of Georgia has proposed legislation endorsing a system that the Government Accountability Office (GAO) castigated in a report issued yesterday. The GAO concluded that almost twenty years after Congress directed that all high-tech medical devices be subjected to a thorough review by the Food and Drug Administration (FDA), before being placed on the market, the FDA still approves most such devices after minimal testing.
This report is especially timely since the Bush administration has long argued that FDA testing and approval shields the drug and medical device manufacturers from civil liability. The Governor of Georgia has just proposed legislation which would give similar protections to these drug and device makers under Georgia law.
The GAO report shows that the system is “fixed” to provide manufacturers speedy approval so that dangerous medical devices can be placed on the market with no recourse for innocent persons maimed or killed by the products.
In the report, the GAO recommended that the FDA. fulfill promises it made 14 years ago to fix its system for approving complex medical devices. The report was mandated by Congress in legislation passed in 2007 to reform the FD.A..
It also comes at a time when scientific reviewers within the FDA have disclosed that most medical devices are given quick approvals with minimal testing because manufacturers tell the FDA. that the products operate just like older, already-approved devices. These scientists have written letters to both Congress and President-elect Barack Obama seeking significant changes at the FDA. Investigations into their claims are ongoing both at the FDA and in Congress.