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USFDA Guidance: Risk & Efficacy Information in Direct-to Consumer Prescription Drug Promo Labeling

A final guidance for the industry was issued today (27 June, 2023) by the US Food and Drug Administration titled "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertising."

This guidance provides recommendations for how quantitative efficacy and risk information may be presented in Direct-to-Consumer (DTC) promotional labeling and advertisements for prescription human and biological medicines, prescription animal medicines, and nonprescription animal medicines (collectively, "promotional communications").

Additionally, the guidance provides recommendations on how to include quantitative efficacy or risk information in direct-to-consumer marketing communications for drugs.

The guidance covers the below-mentioned topics:

  • Providing quantitative efficacy or risk information for the control group, when applicable

  • Presenting probability information in terms of absolute frequencies, percentages, and relative frequencies

  • Formatting quantitative efficacy or risk information

  • Using visual aids to illustrate quantitative efficacy or risk information

The suggestions provided in this guidance apply to quantitative efficacy and risk presentations in DTC promotional communications across various media types (e.g., print, electronic, audiovisual).

Also, there was another guidance that was released earlier today "Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act" which describes examples of how the FDA intends to apply section 503B’s wholesaling provision.


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