MelaFind was submitted for marketing approval in Europe in May 2011. It was approved just five months later. One key reason for Europe’s efficient approval process is that European governments don’t review medical devices directly. Instead they certify independent “notified bodies” that specialize and compete to review new products. The European system works more quickly than the U.S. system, and there is no evidence that it results in reduced patient safety. Rather than tweak the current system, why doesn’t the U.S. just adopt the European model and call it a day? Our health and our economy would be better off for it.
Reihan Salam points to a review by Daniel Klein from 2001 of a book by Henry I. Miller.
Miller develops a reform proposal that would attempt to institutionalize the cooperative virtues of the European systems. Drug development and application would be overseen by nongovernmental “drug certifying bodies.” They would compete with one another for hire by companies developing a new drug. The hired drug-certifying body would oversee investigation, help develop the new drug application, and then make an initial decision on the application—that is, decide whether to certify the drug. The European agencies would also be permitted to serve as drug-certifying bodies. The company and its certifying body would then go together to the FDA for final approval of the new drug. The FDA, therefore, would retain final authority, but would rely on a set of trusted drug-certifying bodies, which would compete to get it right, do it quickly, and keep fees low. Under such a regime, says Miller, the FDA “becomes primarily a certifier of certifiers, rather than a certifier of products.”
Speaking of the FDA, apparently, as soon as someone writes an app for a mobile phone that does something like monitor glucose levels, this threatens to make turn the phone into a medical device, inviting the FDA to regulate.Scott Gottlieb and Colleen Klasmeier write,
The ambiguity created by the guidance and the agency’s premarket review processes forces innovators to seek the FDA’s nod for every new launch and every small advance. This slows progress to a crawl. Worse, the lag may be almost entirely unnecessary, as most of these products are not properly regarded as a medical device in the first place.
I would imagine that Thalidomide would be cited forever as a reason not to do any of this. We must be “safe” at any and all cost to overall well-being and even overall safety.
Thalidomide is a good permanent reason to test new uses of chemical substances thoroughly for unknown and potentially harmful side effects and to learn who is susceptible to them.
It is not a good reason to regulate the use of technology to merely communicate or certain kinds of truthful information or display it in a way useful and easily digestible to the end user.
I used to work for a startup that pulled data from blood glucose meters onto phones. (I can’t read the gated WSJ article, so I don’t know if the company was mentioned, or what else was said).
There seemed to be a massive inflection point around “interpreting” data. If we just showed you the exact numbers from your meter, we were (not too onerous?) one class of medical device thingy. If we wanted to show a graph of those numbers, we became a higher class of device, with much more scrutiny applied.