FDA Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs

FDA: Advertisements “should focus on the most important risk information rather than an exhaustive list of risks.” 

Over the past few years, the Food and Drug Administration (FDA) has conducted numerous studies showing that consumers don’t actually read the long list of risks and adverse events included in printed drug advertisements. Consumers may get overwhelmed by the amount of information, or may lack the technical background to understand the content. FDA believes this could be harmful to consumers for a number of reasons–some may disregard the information if it is confusing, or consumers may avoid truly beneficial medication based on an ad’s overemphasis on certain peripheral risks.  

Last Friday, the agency released guidance that “strongly recommended” companies change their methods for disclosing risk information in consumer-directed prescription drug ads and promotional labeling. FDA stresses “consumer-friendly language” and recommends that only the most serious and most common risks associated with a product, instead of an exhaustive list that includes “less pertinent information,” be included.

View the Guidance: Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs

Under FDA regulations, a print advertisement for a prescription drug must include “a true statement of information in brief summary relating to side effects, contraindications…and effectiveness” (21 CFR 202.1(e)(1)). The agency notes in its guidance that companies often fulfill this requirement by including the complete FDA-approved package insert (PI). To fulfill the adequate directions for use requirement for consumer-directed print promotional labeling for prescription drugs, companies have also used the PI.

FDA believes that since the target audience for the PI is actually healthcare professionals, companies should tailor the risk information in consumer-directed materials to the intended reader–one that may not be able to fully comprehend the technical language in the PI. Instead, FDA outlines an alternative disclosure approach they call a “consumer brief summary.” 

FDA’s guidance encourages consumer-friendly language. “The consumer brief summary should be written in language designed for understanding by a broad target audience with various levels of literacy skill,” the agency states. “Technical language scientific terms, and medical jargon should be avoided.”  FDA recommends that companies should say “do not use if you have…” rather than “contraindications,” for example. 

The guidance also offers somewhat vague formatting suggestions. “Arranging information in text boxes (i.e., paragraphs of information on a similar topic surrounded by borders) with headings…and other attention-drawing symbols (e.g., bullets, capitalization of select words or phrases) may also be useful to consumers,” FDA states. 

As to content, the agency’s “current thinking is that the consumer brief summary should provide clinically significant information on the most serious and the most common risks associated with the product and omit less pertinent information.”

FDA offers information that companies should still include in the consumer brief summary:

• Boxed Warning
• All Contraindications
• Certain information regarding Warnings and Precautions, including “the most clinically significant information from the Warnings and Precautions section(s) of the PI; information that would affect a decision to prescribe or take a drug; monitoring or laboratory tests that may be needed; special precautions not set forth in other parts of the PI; and measures that can be taken to prevent or mitigate harm. 
• Most frequently occurring Adverse Reactions, and if the product has more than one indication, the most common Adverse Reaction for each indication being promoted. Other Adverse Reactions must also be included, “such as those that are serious or those that lead to discontinuation of the drug or dose adjustment.” 
• Material information about risks, including their severity and potential early warning signs
• Any clinically significant drug interactions
• Information related to special populations – children, the elderly, pregnant or nursing women, people with liver or renal impairment
• Information regarding topics consumers should discuss with their healthcare providers
• Reminder that this information is not comprehensive

Despite the last bullet point, companies still have to include quite a comprehensive risk profile in their printed ads. What can companies exclude under this new guidance? “[D]osage and administration, how the drug is supplied, clinical pharmacology, specific directions regarding use of the drug (such as how to perform an injection or how to use a patch), or how long the drug takes to work,” states FDA. “However, excluding certain information from the consumer brief summary does not mean that the same information can be omitted from other parts of the promotional piece (e.g., information that a drug is administered via an injection versus orally might be material information that is required in the main body of the promotional piece, while detailed instructions for use may be omitted from the consumer brief summary).”

FDA also includes some potential, reader-friendly formats that companies may use, including prescription drug “facts box,” a Question and Answer section, and standardized headings.

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The agency’s recommendations to include clear, understandable language is a laudable goal, and it will be interesting to see how companies incorporate this into their ads. However, promotional materials that minimize a product’s risks have long been one of the FDA’s prime enforcement targets. It is unclear whether this guidance provides enough certainty for companies to feel comfortable leaving off a few “peripheral risks.” 

Comments are due on this guidance by May 11, 2015.