Personalized Medicine: Facilitating a Partnership with the FDA

The path to personalized medicine traverses a largely uncharted legal and regulatory landscape that offers both challenge and opportunity. As we advance rapidly into an era of medical treatment tailored to individuals with information from increasingly sophisticated diagnostic tests, the FDA and other regulators are faced with a new paradigm that includes labeling of approved drugs with companion diagnostics and the co-development of drugs and companion tests.

As diagnostic technologies grow more complex, laboratory-based tests that do not require FDA clearance present a certain opportunity to industry and a challenge to regulators. Possible legislative proposals for incentives for co-development of drugs and companion diagnostics create potential new challenges and opportunities for regulators and industry. Personalized medicine will also play an increasing role in studying post-market drug safety.

The healthcare system, including providers, payers, and patients face equal challenge and opportunity in the changing legal and regulatory landscape of personalized medicine. This includes the roles of comparative effectiveness initiatives, possible limitations on payment for tests and physician services, as well as patient privacy issues. The success of personalized medicine demands knowledge and careful navigation of this legal and regulatory landscape.