David Hilzenrath at the Project on Government Oversight reports here about what strikes me as a bunch of future disasters waiting to happen. An excerpt:
When makers of medical devices learn that one of their products has malfunctioned in a way that could kill or seriously injure people, they are required to file a report with the Food and Drug Administration (FDA). The reports are meant to alert regulators that patients may be in danger. However, in the future, under a deal the FDA has negotiated with industry lobbyists, manufacturers could generally wait three months before reporting malfunctions, and they could report malfunctions in “summary” form, according to an FDA document. The deal apparently means that the government and the public could receive less detailed and less timely warnings.
The article then goes on to discuss other troubling deregulatory measures under the FDA-industry deal. For instance, the deal would:
-
Increase FDA reliance on private reviews arranged by device manufacturers, known as “third party reviews.” The agreement calls for the FDA to “establish a plan for eliminating routine re-review by FDA of Third Party reviews.” That “represents a potential lowering of medical device safety standards,” Jack Mitchell of National Center for Health Research said at a public FDA meeting last year, according to a transcript. The FDA has expressed dissatisfaction with third party reviews, including concern about “incompetent third parties,” and the agreement calls for the agency to take steps to improve them.
-
Under certain circumstances, stop the FDA practice of requiring manufacturers to conduct “post-market surveillance studies”—analyses of how safely and effectively devices are performing once the FDA has allowed them to be sold. The agreement says the FDA won’t require such studies if it has access to sufficient “real world data.”
-
Guarantee the medical device industry “at least” a quarter of the seats on the governing board of the National Evaluation System for health Technology (NEST). That organization is tasked with developing alternatives to the traditional scientific data used in FDA decision-making. The board seats would give the device industry another inside track to influence FDA policy.
