Draft Guidance Outlines Requirements for Pre-Dissemination Review

This week, the Food and Drug Administration (“FDA”) issued a draft guidance document describing how it intends to implement the review of certain direct-to-consumer prescription drug television advertisements (“TV ads”) prior to dissemination. Categories of TV Ads Subject to Review This draft guidance outlines FDA’s implementation of the review authority granted under the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) that created section 503B of the Federal Food, Drug, and Cosmetic Act (“FDCA”) (21 USC 353(b)). Under FDAAA, FDA is authorized to require the submission of any TV ad for a drug at least 45 days prior to the ad’s dissemination. FDA can then require the drug’s sponsor to make changes to the ad or include additional information. Using a risk-based approach, FDA’s draft guidance proposes several categories of prescription drugs that would be subject to this pre-dissemination review. Additionally, FDA details the review submission process, including the information drug sponsors would be required to provide.

The draft guidance sets out six categories of TV ads that require pre-dissemination review:

• Category 1: the initial TV ad for i) any prescription drug, or ii) any new or expanded approved indication of a prescription drug;

• Category 2: all TV ads for a prescription drug subject to a risk evaluation management strategy (“REMS”) with elements to ensure safe use of the drug...

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