Reforming the FDA

by Reihan Salam

Towards the end of his review of Joseph V. Gulfo’s new book Innovation Breakdown, a harrowing first-hand account of how the FDA nearly killed a promising new medical technology, George Mason University economist Alex Tabarrok references Europe’s approach to regulating medical innovation: 

Compare MelaFind’s experience in the U.S. with its reception in Europe: 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.

Henry Miller of the Hoover Institution has advanced a proposal along these lines. Instead of certifying products itself, the FDA would work through approved nongovernmental drug-certifying bodies; pharmaceutical and medical device companies would hire these bodies to evaluate the efficacy of new products, but the FDA would have final say. One obvious concern is that biotech firms might hire unscrupulous, low-cost drug-certifying bodies that do a slapdash job. Yet these bodies would presumably fail to pass muster with the FDA, which would continue to serve as the last line of defense. The desire to hire the cheapest and most compliant drug-certifying bodies would have to be balanced against the desire to hire a body that will get its decisions approved. 

Less controversially, Miller calls for a U.S. commitment to accepting the judgments of select foreign regulatory authorities with strong reputations for protecting the interests of consumers, like those found in the European Union, Canada, and Japan. Both strategies could do much to facilitate innovation in the life sciences.