More criticism of FDA's medical device approval process

Not long ago, we recounted a controversy within the Food and Drug Administration regarding its division charged with approving medical devices.  That controversy was further stoked yesterday when nine scientists within the division authored a letter to President Obama criticizing FDA management of the approval process and charging that unsafe devices are routinely approved without adequate testing.

The FDA is the arm of the federal government charged with approving medications and medical devices.  For thirty years, it has divided medical devices into three categories depending upon their relative danger.  Category I devices are simple, safe tools suchs as tongue depressors, forceps and reading glasses which pose little danger to consumers and require almost no investigation or approval.  Category II devices pose some potential danger and are subject to fairly superficial safety review which is completed promptly. The New York Times identified the mercury thermometer as a typical Category II device.

The problem arises with potentially dangerous Category III devices such as pacemakers, replacement heart valves, and joint replacements.  Congress charged the FDA with close scrutiny of these devices, but allowed existing devices to be "grandfathered" for approval without a new investigation.  The FDA granted this approval for existing devices and their "substantial equivalent" without ever defining the latter term.  Despite warnings and threats from Congress over the past 15 years, the FDA has continued to grandfather for approval all manner of "equivalent" devices with inadequate investigation. 

Over the past two decades it has become apparent that poor management within FDA, poor oversight of manufacturer-physician relationships, and "medical money" in general have resulted in unwarranted and unsafe approval of numerous devices that have caused death or injury to patients.  The nine "dissident" scientists claim that "patients are routinely put at risk from high-risk medical devices that are approved for sale even though manufacturers have never proved that the products are either safe or effective".  The Government Accounting Office recently released a report that came to the same conclusion. 

The nine scientists' January, 2009, letter to the Obama Administration claims that FDA management has now commenced an investigation of them for making their complaints public through correspondence with Congress and the incoming President.  The scientists suggest this is an attempt to intimidate and silence them for blowing the whistle on a persisting, unsafe condition.

This controversy gained heightened importance and received additional scrutiny during the summer of 2008 when device manufacturers sought and received immunity from private lawsuits through an appeal to the conservative U.S. Supreme Court:  the Court majority held that consumers received adequate protection from the FDA and that Congress intended, back in the 1970s, to shield manufacturers from meddling with the approval process through state-approved legal actions.  This "reinterpretation" of Congress' 1970s intent was a reversal of the Court's previous thinking on the issue, thirty years removed from the Congressional act.  A similar case seeking immunity for drug manufacturers who have gained FDA approval of medications is currently pending before the Court.