FDA Wants Drugmakers to Simplify Risk Information in DTC Print Ads

February 12, 2015

The FDA is making a second attempt at encouraging drugmakers to simplify the risk information they include in consumer print advertisements.

The agency issued draft guidance in 2004, never finalized, that tried to steer drugmakers toward easier-to-understand warnings in advertisements, but drugmakers largely resisted. Instead, they have traditionally included the full risk information from the drug’s package insert in advertisements, which often includes a lengthy list of every potential adverse event a drug can cause.

In new draft guidance issued last Friday, the agency clarifies what should and should not be included in DTC advertising, as well as offering new examples of the type of language it wants drugmakers to include in a section of the ad it calls the “consumer brief summary.”

For example, the risk information should make note of contraindications and black box warnings, but it need not list all potential adverse events. Adverse event warnings can be limited to just the most common adverse events for each approved indication, serious events and those that might force a user to stop taking the drug or alter dosage.

In terms of language used in the consumer brief summary, the FDA is recommending drugmakers translate warnings in the package insert into a conversational tone, using lay language. Instead of “contraindications,” for example, the FDA suggests using “do not use if you have” or “who should not use.” In place of “somnolence,” the agency recommends “drowsiness.”

Advertisements should also refer consumers to the FDA website where they can access full package insert information.

Comments on Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs are due May 7. View the guidance at www.fdanews.com/02-06-15-riskinfoguidance.pdf. — Lena Freund