FDA Proposes Study to Improve DTC Print Ad Disclosures

June 21, 2017

The FDA is proposing an experimental study to examine the effects of risk disclosures and fine print in direct-to-consumer drug advertising.

Historically, drug sponsors include their products’ risk information in the main claims section and a separate summary page to fulfill Section 502(n) of the FD&C Act, which requires a “brief summary” describing side effects, contraindications and effectiveness, and 21CFR 202.1, which requires a “fair balance” between the three categories of information.

However, recent research indicates far more consumers read the main body of the ads compared to the summary. In addition, repeating information can also lead to “overwarning” — people can start to ignore warnings if they are continually exposed to them. — Zack Budryk

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