What Comes After the FDA’s Drug Monopoly?

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). 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 care.

The 1962 Kefauver-Harris Amendments, enacted after the thalidomide tragedy, required the agency to judge a drug’s safety and effectiveness—an expansion that has slowed innovation and delayed patients’ access to lifesaving treatments. Today’s “drug lag” and “drug loss” mean Americans wait years and pay billions more for medicines already available overseas.

What Comes After the FDA’s Drug Monopoly?

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