Oct. 19, 2018 – It is important for drug companies to make quantitative presentations of risk or efficacy information in direct-to-consumer (DTC) ads more consumer friendly, according to draft guidance issued by the FDA’s Office of Prescription Drug Promotion (OPDP). The draft guidance, “Presenting Quantitative Efficacy and Risk Information in [DTC] Promotional Labeling and Advertisements,” was announced by the agency in the Oct. 17 Federal Register.

“The new draft guidance on presenting quantitative efficacy and risk information in DTC advertising builds upon the FDA’s ongoing research program to provide helpful clarification to the industry on how best to present comparisons, both in wording and in visuals,” said Coalition for Healthcare Communication Executive Director Jon Bigelow.

OPDP states that the need for this draft guidance arises from it observing an increase in quantitative presentations of efficacy and risk information in DTC promotional materials submitted to the agency. “FDA understands that firms may experience challenges when determining how to present this kind of quantitative information in DTC promotional materials,” the draft guidance states. “For these reasons, FDA is issuing this guidance to provide recommendations … and to encourage firms to follow these recommendations when including such information in their DTC promotional materials.”

The draft guidance, which OPDP states applies to all DTC promotional materials, regardless of medium (e.g., print, electronic, audiovisual, broadcast), covers the following topics:

• Presenting probability information in terms of absolute frequencies, percentages and relative frequencies;
• Formatting quantitative efficacy or risk information;
• Using visual aids to illustrate quantitative efficacy or risk information; and
• Providing quantitative efficacy or risk information for the treatment group and the control group.

Each topic is described in detail, outlining the pros and cons of different approaches and providing samples of various information treatments. For example, OPDP states that consumers receiving information about a drug’s efficacy and risk rates in terms of absolute frequencies or percentages can more easily process and evaluate the information than when the same information is in a format that requires them to perform a calculation to interpret the probabilities. Alternatively, OPDP cites research that suggests consumers do not understand relative frequencies (e.g., a 33 percent reduction in symptoms).

The agency is accepting comments on the draft guidance until Dec. 17.