FDA Device Regs Help, Hurt Consumers: Study
Research conducted by University of Pennsylvania Wharton School professors on second and third generation coronary stents supports the FDA position that reductions in medical device approval standards would reduce consumer welfare. But it also supports FDA reform proposals saying that more relaxed premarket requirements and enhanced post-market surveillance would yield considerable consumer welfare gains. In a Public Policy Initiative issue brief, the authors say that any gain from a change in review standards would critically depend on the rate and cost of learning via post-market surveillance.
The researchers looked at approval of Class 3 coronary stents in the U.S. and the European Union (EU) and created a model to capture the regulator’s tradeoff between consumer risk exposure and access to innovative products. “Our research sheds some much needed light on the consumer welfare implications of current FDA regulations and takes a useful step toward clearing up some of the confusion prevalent in the debate over the risk-access tradeoff,” they write.
The approval process for Class 3 devices in the EU is very different from the FDA process, the researchers found. To obtain a CE mark of conformity in the EU, a Class 3 medical device needs only to demonstrate safety and performance, not necessarily effectiveness. “Compliance with this standard usually can be demonstrated with much simpler and cheaper clinical trials than required by FDA,” the report says. “For this reason, medical device manufacturers (many of which are U.S. based) typically introduce products in the EU well before they seek FDA approval, if they decide to enter the U.S. market at all.”
The researchers’ model found that the predicted greater access in the EU is evident in the fact that, on average, 49% of the stents used in the EU are unavailable in the U.S. And the predicted greater risk in the EU is suggested by the facts that, on average, products in the EU experience less usage overall and higher volatility in usage patterns when first introduced. The U.S., the researchers say, exhibits no such patterns. “The estimated model also suggests that without any clinical trials, the stent market could virtually fail, with very few patients selecting a stent due to the risk of receiving a low quality device,” they add.
The model found that if post-approval learning rates approach those observed from clinical trials at comparable cost, the benefits from such a policy change are substantial. “There is merit … to the argument that requiring shorter trials with enhanced post-approval testing could improve consumer welfare,” the paper concludes, “but the gains from this policy critically depend on the rate and cost of learning via post-market surveillance. For some products, observational learning from real world use may make it difficult to infer product quality (i.e., not having the randomization built into treatment and the control available in clinical trials). For other products, though, and likely for those in our sample, the problem is simply a lack of systematic data collection and sharing of information.”