FDA’s Proposed Standards Require Clear, Complete Communication in Prescription Drug Advertising

Hallowell, Maine, July 1, 2010—Prescription Policy Choices, a nonprofit, nonpartisan organization working to expand access to safe, effective, and affordable prescription drugs, has joined with more than twenty other consumer and health care stakeholder groups to comment on and support the FDA’s proposed new standards for direct-to-consumer advertising of prescription drugs. On Friday, June 25, 2010, Community Catalyst's Prescription Access Litigation filed comments to the FDA on the groups’ behalf.

“PPC’s support of the FDA’s proposed new standards for direct-to-consumer advertising of prescription drugs is directly aligned with our efforts to promote policies we believe will help improve access to safe, effective, and affordable drugs,” states PPC Executive Director Ann Woloson. “Information about prescription drug side effects and contraindications is as important—if not more important—as information about prescription drug benefits.”

The standards will help protect consumers by ensuring that direct-to-consumer radio and TV advertising is “presented in a clear, conspicuous, and neutral manner,” thereby enhancing consumers’ understanding of the risks associated with prescription drugs. More specifically, the standards will ensure the following:

• Information is presented in language that is readily understandable by consumers.
• Audio information is understandable in terms of the volume, articulation, and pacing used.
• Textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily.
• The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.

“Unfortunately, direct-to-consumer radio and TV advertising is often skewed toward portrayals of people living idealized lives thanks to the benefits of whichever drug is being promoted,” says Woloson. “In contrast, side effects and contraindications are downplayed or even masked by advertisers eager to promote and sell their drugs.”

“Some prescription drugs are beneficial, but others have risks that may outweigh the benefits,” continues Woloson. “PPC works to ensure consumers, providers, and policymakers have access to clear, objective, evidence-based information about prescription drugs for making well-informed health-related decisions.”