How the FDA Impedes Innovation

Mike Mandel  has a good piece, significantly published by the Progressive Policy Institute, on the FDA and innovation. MelaFind is a handheld computer vision system, database and expert system that helps dermatologists to identify which skin lesions should be biopsied for melanoma. The device works quite well but the FDA has deemed the device “not approvable” because (quoting Mandel):

• The device did not do better than the experienced dermatologists in the study (“the FDA review team does not believe this is a clinically significant difference between MelaFind and the examining dermatologist”)
• The device was tested on lesions identified by experienced dermatologists, not on the broader set of lesions that might be identified by “physicians less experienced than these dermatologists.”
• The device did not find every melanoma in the sample (“Since the device is not 100% sensitive, if use based on the device’s diagnostic performance reduces the number of biopsies taken, harm could ensue in the form of missed melanomas.”)
• The device was not demonstrated to make inexperienced physicians the equal of experienced dermatologists (“Currently, formal training is offered to physicians to become board certified dermatologist and thus be able to diagnose clinically atypical lesions. The FDA review team would have to compare this board certification training to that offered by the sponsor to those physicians operating MelaFind to determine if it is found adequate.”

Some of these complaints are legitimate, others not so much. But even if MelaFind is not perfect today nor appropriate in all circumstances it’s exactly the type of innovation that we should encourage. Devices such as MelaFind could not only improve medical care they can reduce costs and make good quality medical care more widely available in developing countries, for example, where experienced dermatologists are in short supply.

Most importantly, innovations get better over time. But if you impede the first generation the second generation may never come into existence and, as Mandel notes, no first-generation device could satisfy the FDA’s conditions. It’s like refusing to give the Wright Brothers a license to fly because their first airplane only flew for 59 seconds.

The signal that is being sent by the FDA impedes all medical innovation.

For more on the FDA see FDAReview.org.