Lexology September 11, 2025
Earlier this week, the U.S. Food & Drug Administration announced that it is stepping up its enforcement related to misleading prescription drug advertising and is beginning a new rulemaking that will effectively put an end to most television commercials that promote prescription drugs.
In the FDA’s rulemaking, the FDA is proposing to remove the “adequate provision” exception, which allowed advertisers to include only major risks in advertising and then direct consumers to another location (such as a website or toll-free number) for full safety information. By requiring full safety information to be presented in broadcast advertising, it will make it nearly impossible – as a practical matter – for pharmaceutical advertisers to run television commercials.
In announcing the...
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