FDA Issues Draft Guidance on Presenting Risk Information in Promotional Materials

The US Food and Drug Administration posted a draft guidance for industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion, on its website May 26, that describes factors the agency considers when evaluating advertisements and promotional labeling for prescription drugs and medical devices. Although not stated, this draft guidance may have been pushed through as a result of the industry backlash from FDA’s issuance of 14 untitled letters for online advertising violations (see back story, FDA Issues 14 Untitled Letters for Online Ad Violations). The draft guidance applies to promotional materials for consumers and healthcare professionals as well as promotional materials in all media, including websites. The document also affects product benefit information that appears in promotional materials.

“FDA believes it is critically important to disclose risk information in prescription drug and medical device promotion appropriately and effectively to healthcare professionals and consumers,” states the draft guidance. “This information helps consumers know whether drugs or devices may be appropriate for them as well as what they should tell their healthcare professionals about before taking or using or while taking or using a product. It also lets consumers know what risks they might experience and what steps they need to take for safety reasons (e.g., no driving) because of taking or using a product.

Direct-to-consumer prescription drug advertising research has shown that 60%of patients believe ads directed at them do not provide enough information about risks, according to the dfaft guidance. In addition, 60% of physicians believe that “patients have little or no understanding from these ads about what the possible risks and negative effects of the products are,” states the guidance.

After providing a legal overview of the requirements under the Food, Drug, & Cosmetic Act regarding promotional language, the draft guidance offers insight into what FDA looks for in risk-related materials for drug products. Specifically, states the guidance, the agency focuses on the promotional item’s  “net impression (i.e., the message communicated by all elements of the piece as a whole),” according to the draft guidance. “Manufacturers should therefore focus not just on individual claims or presentations, but on the promotional piece as a whole,” advises the guidance.

The document describes a few examples, including one in which a full-page drug advertisement notes benefits in large type at the top of a page with risk information in small type at the bottom of the page. The draft guidance says the reader may perceive the product’s benefits to be greater than its risks based on the ad’s impression.

The draft guidance goes into detail on how FDA reviews promotional materials such as the language used for consumers (e.g., “fainting” versus “syncope”), the presentation of headlines and subheds, and the way risk information is conveyed in terms of focusing on the negative or positive aspects. The document also discusses, among other factors, the relevance and location of presented risk-information, the impact of an ad’s format such as font or its length such as a 30-second versus a 60-second commercial on the consumer, the target audience, and the information contained in package inserts.

“The agency hopes that by discussing the most relevant factors and by providing specific examples, manufacturers will gain a better understanding of what they should consider as they develop the content and format of their promotional communications,” concludes the draft guidance.