Opinion: Patients might finally receive practical information with prescriptions — if the FDA doesn’t blow it

STAT September 12, 2023
Baruch Fischhoff, Steven Woloshin, Tamar Krishnamurti and Barry Dewitt

Patients often ask two questions about every medical treatment: Will it help me? Will it hurt me? The Food and Drug Administration knows many of the answers. It wants patients to know them, too.

After years of deliberation, the FDA has proposed giving patients a simple one-pager for every prescription drug with the information needed for safe and effective use. The new form will supplement the long package insert that patients currently get with their prescriptions — and which, we imagine, most people throw away without reading, just as we all tend to click on “Agree” on lengthy privacy policies online.

But we are afraid that the FDA will blow the opportunity with poor design and inadequate testing of the...

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