medical-devices-and-drugs

The Right to Try and the Future of the FDA in the Age of Personalized Medicine

Do citizens have the right to determine their own courses of treatment and to use medicines and devices that they think could improve their health? And, to the extent regulators seek to restrict that freedom, what is the practicality and cost of doing so? These questions animate the debate over the so-called “right to try,” a growing movement to allow terminally ill individuals to experiment with alternative medical treatments, therapies, and devices that are tightly controlled by the Food and Drug Administration (FDA). This essay argues that such an expansion of the right-to-try notion may be happening already as technological innovation decentralizes and democratizes medical decisions. This expansion does not mean that all FDA regulation will fade away, but it will necessitate a move away from the agency’s command-and-control methods of the past and toward a new focus on patient empowerment through enhanced choice, improved risk education, and clearer consent mechanisms.

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