The Need for FDA Reform: Four Models

The FDA’s role in drug and device approval needs to change, and only Congress can bring drug and device marketing into the 21st century. The FDA should be reformed to create a market in which different patient and doctor preferences regarding risks and benefits can be better served. Allowing for a diversity of preferences will improve patient health outcomes.

Decentralizing decision-making must include trusting doctors and patients to make informed decisions by allowing a technologically competitive marketplace to help them make life- and health-altering decisions. The models proposed in recent FDA reform research are workable solutions that encourage policymakers to trust in people, technology, and competitive markets, not government regulators and an outdated regulatory system.

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