Dangerous Times: The FDA’s Role in Information Production, Past and Future

Dangerous Times: The FDA’s Role in Information Production, Past and Future

By Amy Kapczynski. Full Text Here.

The FDA faces many current threats to its power as a drug regulator. Many so-called right-to-try bills have passed at the state level, and versions have been introduced federally that could reduce or eliminate the Agency’s ability to oversee expanded access to experimental drugs for seriously ill patients. The recently passed 21st Century Cures Act urges the Agency to approve drugs with less evidence, but gives it no significant new tools to ensure that companies produce adequate data after a drug enters the market. In the last few years, several courts have called into question whether core parts of the FDA’s drug regulatory framework are consistent with the First Amendment. To understand the stakes of these potential shifts—and to appreciate their significant dangers—we must articulate more clearly the central aim of the FDA’s drug regulatory system. That aim is not to paternalistically protect patients, nor is it to certify the quality of medicines. It is instead to foster the production and validation of high-quality information about medicines. Unregulated markets cannot adequately perform either function, and modern FDA law is shaped substantially by this fact. The point is underappreciated both in the academic literature and in policy debates. But once it is clearly sketched—via an analysis of the market for information about medicines and the FDA’s drug marketing restrictions—we can more clearly see the problems posed by these recent challenges to the FDA’s drug regulatory authority. Quite simply, they put at risk our system for understanding the medicines we put in our bodies. They should be rejected or stayed until we know better how to make them compatible with the FDA’s critical information production and validation functions.