|Is That Device Safe?|
The Food and Drug Administration has been justly pilloried for grievous flaws in its regulation of foods and drugs. Now Congressional investigators, and some of the agency's own scientists, are charging that the F.D.A. has failed to adequately regulate medical devices
The Government Accountability Office recently reported that the F.D.A. has failed - for decades - to subject some of the riskiest devices to a rigorous review mandated by Congress. A group of F.D.A. scientists complained to the Obama transition team - and before that to Congress and to the agency's commissioner - that during the Bush years, managers in charge of medical device reviews had corrupted and distorted the process in ways that put the public at risk.
Under a 1976 law, the F.D.A. is required to divide medical devices into three classes and to impose different levels of scrutiny. The riskiest Class III devices - such as implantable pacemakers and replacement heart valves - require the most stringent review, usually including clinical evidence that they are safe and effective.
Unfortunately, the law left a gaping loophole. Certain types of Class III devices already on the market, and later devices deemed substantially equivalent to them, could be approved for sale with the less stringent review - until the F.D.A. required them to pass a more rigorous test or put them into a lower class.
The agency made so little progress in closing the loophole that Congress in 1990 ordered it to quickly decide which classes the grandfathered devices should be in and to schedule rigorous reviews for those remaining in Class III. Although the agency has done that for most of the remaining devices, the G.A.O. found that it has still not completed the task.
In a recent five-year period, the F.D.A. used the less stringent procedures to clear 228 Class III devices, including certain types of metal hip joints and implanted blood access devices.
The Obama administration will have to send a clear signal to the bureaucracy that the days of neglect are over. Officials will also have to make clear that the Bush administration's practice of distorting science and weakening regulation to favor industry also is over.
We are pleased to hear that F.D.A. scientists have been raising the alarms. As Gardiner Harris reported in The Times, internal documents show that front-line scientists believe their managers have become too lenient with industry and, in one case, improperly forced them to alter reviews of a breast imaging device after Christopher Shays, a former Republican congressman from Connecticut, intervened on behalf of the manufacturer.
The G.A.O. has rightly urged the F.D.A. to make final decisions on all grandfathered Class III devices. That would be a good start - provided the reviews are honest and uncoerced - but not sufficient. The next F.D.A. commissioner should ensure that past decisions on medical devices were properly made. Given its sorry performance in so many areas important to public health and safety, the agency is ready for a major overhaul.
New York Times