Regulatory changes needed to spur market for comparative effectiveness research

The market for comparative effectiveness research is rapidly evolving. Private actors such as health plans that previously consumed this information, and medical product makers that want to compete on it, have increasing reason to conduct this research. This should shrink the role for federal programs aimed at these efforts.

In the past, market failures prevented some of this activity. In some cases, these market impediments are being righted. In other cases, they must be addressed.

Health plans often developed comparative analyses, but never had an incentive to publish them. They used these analytics to make private, proprietary decisions. As risk for the provision and payment of care shifts to providers, there will be a more vigorous market for the consumption and sharing of these analytics.

Health plans will now have ample incentive to market these data as a service to integrated health systems and providers that are bearing capitated risk. These analytics are increasingly being used for proprietary guidelines that health plans are selling to providers.

On the product-development side, the picture is different. So long as drug and device companies are prevented from speaking about the results of their comparative studies, they will have insufficient incentive to invest in these analyses.

The current bar for getting comparative claims onto drug and device labels is prohibitive. It requires trials that, in many cases, simply can't be executed.

There's no reason that regulators can't establish a two-tier system for medical claims. The first would continue to set a high bar for what product makers can promote to patients, and perhaps what they can share with providers; the second would set a separate bar for what information can be actively shared with those who make purchasing decisions.

As providers take a more active role in making economic decisions, they will have increasing need for comparative effectiveness information. Along with these changes will also come more opportunities for private actors to develop this kind of bottom-line data.

Dr. Scott Gottlieb, a resident fellow at the American Enterprise Institute, was deputy commissioner of the Food and Drug Administration from 2005 to 2007.