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FDA Clarifies Advertising and Marketing Rules for Certain COVID-19 Drugs

November 2, 2022

The FDA has updated its rules for the advertising and marketing of several drugs to treat COVID-19 — Eli Lilly’s baricitinib, Genentech’s Actemra, AstraZeneca’s Evusheld, Pfizer’s Paxlovid, Merck’s Lagevrio and Eli Lilly’s bebtelovimab — to allow the companies to describe safety and efficacy from clinical trials in their promotional materials.

The agency previously allowed the use of information that is “product-specific, truthful, and non-misleading,” in labeling of products that received emergency authorizations, but stopped short of allowing the information in advertising, promotional or marketing materials. The materials must still state that the drug is not FDA-approved but is authorized for use during the COVID-19 emergency and must include a description of any limitations of clinical trial data.

Companies must submit materials to the FDA 14 days in advance so the agency can provide feedback on any significant issues.

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