medical-devices-and-drugs

Health Options Foreclosed: How the FDA Denies Americans the Benefits of Medical Research

In recent decades, the Food and Drug Administration (FDA) has assumed increasing premarket authority for drugs and devices. Given how the FDA’s regulatory stance has inhibited breakthroughs in the development of medical products, it appears that the agency will stand in the way of emerging technologies such as nanotechnology, synthetic biology, nanorobotics, virally delivered telomerase, and cellular therapy. These new technologies represent not only the means to prevent and cure diseases, but also the key to helping people live longer and healthier lives. We conclude, therefore, that an incremental approach to reform—one that would keep the FDA as the sole arbiter of new medical technologies—is unlikely to work. Rather, we think that a regulatory system based on competitive market approval of drugs and devices is more likely to strike the appropriate benefit-risk balance, including that inherent in the compassionate use of experimental medical treatments.

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