Health Affairs October 15, 2021
Peter J. Pitts

The Food and Drug Administration (FDA) needs a Deputy Commissioner for Regulatory Competitiveness. The “why” is obvious—too many health policy experts, medical product developers, and investors view the FDA as a hindrance to innovation. They see the agency as slow, risk averse, and unpredictable. But the FDA can (and, indeed, must) become an innovation accelerator and a competitiveness enabler.

Reporting directly to the FDA Commissioner, the Deputy Commissioner for Regulatory Competitiveness would aggressively develop, coordinate, and drive agency initiatives that allow new medical products and technologies to come to market faster and less expensively—without sacrificing sound regulatory science. The Deputy Commissioner would help to ensure that therapeutic monopolies are not allowed to continue years after patent expiry and that regulatory...

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Topics: AI (Artificial Intelligence), Biotechnology, Cures Act, Digital Health, FDA, Govt Agencies, Medical Devices, Pharma, Pharma / Biotech, Technology
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