Sens. Richard Burr (R., N.C.) and Tom Coburn (R., Okla.) recently rolled out a new bill designed to significantly improve the regulation of drugs and medical devices at the FDA. The bill, called the “PATIENTS’ FDA Act” is “a bill to help make sure that the FDA fulfills its mission to ensure that patients have access to cutting-edge, life-saving drugs and devices as quickly as possible.”
The basic premise behind this piece of legislation — as expressed by Senators Burr and Coburn — is that the FDA needs to be subject to a great deal more Congressional oversight if it is to fulfill its public health mission in a predictable and timely manner and to keep medical innovation and job creation (related to the development of new drugs, diagnostics, and medical devices) from going overseas.
I found Forbes take on the bill interesting.
Avik Roy states “A lot of the Burr-Coburn plan involves requiring the FDA to do things it’s already supposed to be doing. But there are areas where Congressional action would be especially useful: in improving the accountability and transparency of FDA decisions; in modernizing the FDA’s use of information technology, given the enormous amount of clinical data it must track; reforming the agency’s clumsy conflict-of-interest rules; and making sure the agency is always thinking about the costs, as well as the benefits, of retarding innovation.
The basic problem with the FDA is its perverse incentives. The agency gets punished by Congress and the public when an approved product runs into safety problems, whereas nobody complains about the patients who are harmed when an important new medicine is stalled by the agency. As former FDA Commissioner Andrew von Eschenbach recently put it in the Wall Street Journal, “Until FDA reviewers can be scientifically confident of the benefits and risks of a new technology, it is their duty is to stop it—and stop it they will.””
The entire legislation is 55 pages in length, although the summary is a mere 7 pages. Something to keep on your bedside table to lull you to sleep at night…