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What Comes After the FDA’s Drug Monopoly?

The Wall Street Journal

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November 15, 2025

The FDA's monopoly over drug and device approval—created by the 1938 Food, Drug, and Cosmetic Act and expanded by later amendments—wasn't inevitable and is long overdue for reform ("Advice for Makary's FDA: Get Out of the Way," Letters, Nov. 7).

- JEFFREY A. SINGER

Before the government seized that authority, private organizations like the American Medical Association and the U.S. Pharmacopeia helped certify safety and effectiveness. These voluntary systems informed consumers without restricting access to ca

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