The GAO has recently issued a report on medical devices. The thrust of the report is that “high-risk” medical devices do not receive enough scrutiny from the FDA and that recalls are not handled well. This report and other evidence indicates that the FDA is likely to require more testing of devices. As of now, most medical devices are approved on a fast track that requires significantly less testing than that required for new drugs. (As I have discussed in a forthcoming Cato Journal article, medical devices are also subject to more immunity from state produce liability lawsuits.)
The GAO report is remarkable. The GAO defines its mission as
“Our Mission is to support the Congress in meeting its constitutional responsibilities and to help improve the performance and ensure the accountability of the federal government for the benefit of the American people. We provide Congress with timely information that is objective, fact-based, nonpartisan, nonideological, fair, and balanced.”
But the report on medical devices is entirely unbalanced. It deals only with procedures for approval and the recall process (both of which are judged inadequate.) There is no discussion of either costs or benefits. That is, no evidence is presented that there is any actual harm from the “flawed” approval and recall processes. Even more importantly, there is no evidence presented about the benefits to consumers from easy and rapid approval of medical devices.
As is well known, virtually all economists who have studied the FDA drug approval process have concluded that it causes serious harm by delaying drugs. The import of the GAO Report is that we should duplicate that harm with medical devices. This is an odd and perverse way of providing a “benefit” to the American people.
Filed under: consumer protection, cost-benefit analysis, regulation, torts Tagged: FDA, Medical Devices