Off-label information solicited by a drug manufacturer violates which US federal act?

Off-label information solicited by a drug manufacturer violates which US federal act?

• A. FD&C Act
• B. Pure Food Act
• C. Federal Trade Commission Act
• D. Consumer Protection Act

Answer: (A)

In the United States, promotion of drugs for off-label uses is governed by the Food, Drug, and Cosmetic Act. This act requires that drug labeling and promotional materials reflect only FDA-approved indications. Soliciting or distributing information about unapproved uses is considered misbranding and illegal promotion, which the FDA enforces under the FD&C Act. The other options aren’t the primary federal basis for this restriction: the Pure Food Act is an older predecessor, the FTC Act governs general truth-in-advertising but the specific prohibition on off-label promotion rests with the FD&C Act, and there isn’t a federally enacted “Consumer Protection Act” that applies here.

In the United States, promotion of drugs for off-label uses is governed by the Food, Drug, and Cosmetic Act. This act requires that drug labeling and promotional materials reflect only FDA-approved indications. Soliciting or distributing information about unapproved uses is considered misbranding and illegal promotion, which the FDA enforces under the FD&C Act.

The other options aren’t the primary federal basis for this restriction: the Pure Food Act is an older predecessor, the FTC Act governs general truth-in-advertising but the specific prohibition on off-label promotion rests with the FD&C Act, and there isn’t a federally enacted “Consumer Protection Act” that applies here.