On Mar. 12, 2012, FDA released a draft guidance document for industry direct-to-consumer (DTC) television advertisements that describes FDA’s plans for implementing predissemination review.
The FDA Amendments Act of 2007 authorizes FDA to require drug companies to submit DTC TV ads for a drug no later than 45 days before dissemination of the ad. After reviewing, FDA can recommend changes needed to protect the consumer or changes consistent with prescribing information. FDA can also recommend including statements that address the efficacy of the drug for specific population groups. The new draft guidance lists the categories of TV ads FDA plans to review, explains how it will notify sponsors that review is required, and details the information sponsors will need to submit.
In the guidance document, FDA says that the categories targeted for predissemination review will “enable the agency to leverage its limited resources to best protect the public health by ensuring that certain high risk and high impact TV ads accurately and effectively communicate key information about advertised products, including their major risks and indications.” The six targeted categories include:
Category 1: Initial TV ad for a prescription drug or for a new or expanded approved indication for any prescription drug
Category 2: TV ads for prescription drugs subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to assure safe use
Category 3: TV ads for Schedule II controlled substances
Category 4: TV ad for a prescription drug with a safety labeling update
Category 5: TV ad for a prescription drug after the sponsor received an enforcement letter relating to the TV ad for that product
Category 6: Any other TV ad identified by FDA (1).
The guidance was prepared by the Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research, in cooperation with the Advertising and Promotional Labeling Branch in the Center for Biologics Evaluation and Research at FDA. The comment period is open for 60 days.
1. FDA, Guidance for Industry Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad Pre-Dissemination Review Program (Rockville, MD, March 2012).