This week the FDA issued a revised draft guidance describing the agency’s thinking on the requirements for consumer-directed print prescription drug advertisements and promotional labels. The document updates an earlier draft guidance from February 2015 with the addition of prescription animal drugs.
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Agency has responsibility for oversight of the labeling of drugs and the advertising of prescription drugs for human and animal use. This includes livestock drugs advertised in publications such as Bovine Veterinarian and Drovers CattleNetwork .
Under FDA rules, drug companies must include with their print ads a brief summary including of side effects warnings, precautions, contraindications, cautions, special considerations, important notes and effectiveness. This is referred to as the brief summary requirement.
For labeling FDA recognizes two types of labeling for drugs: FDA-required labeling5 and promotional labeling. Promotional labeling generally any labeling, other than the FDA-required labeling, that is devised for promotion of the product. Drug labeling generally must bear “adequate directions for use, although there are some exemptions if certain conditions are met.
The revised draft guidance recommends alternative approaches firms may use to develop content that can be used to fulfill both the brief summary requirement for consumer-directed prescription drug print advertisements and the requirements for consumer-directed prescription drug print promotional labeling pieces. The document also provides suggested research-tested formats for this information to illustrate possible approaches companies might use to satisfy the requirements of the statute and regulations.
The FDA will accept comments to the public docket regarding this reissued draft guidance from interested stakeholders until October 5.
For more information, visit the FDA website.