Last week, FDA released a draft guidance document in response to requests for more specific guidelines on how risk information should be disclosed in consumer-directed advertisements. This revised draft guidance, Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs, replaces a January 2004 draft guidance discussing risk disclosure and applies only to printed advertising and promotional materials for prescription drugs and biological products.
Under Section 502(n) of the Federal, Food, Drug, and Cosmetic Act, companies are required to provide a brief summary relating to side effects, contraindications, and effectiveness in any print advertisements for prescription drugs. Currently, most companies satisfy this requirement by including a copy of the complete risk-related section of the package insert (PI). See 21 U.S.C. § 352(n); 21 C.F.R. § 202.1(e)). Additionally, promotional labeling for prescription drugs must be accompanied by “adequate information for such use” that is the same “in language and emphasis” as the FDA-approved labeling. 21 U.S.C. § 352(f)(1); 21 C.F.R. § 201.100(d). Companies generally meet this requirement to provide prescribing information in promotional labeling by providing the complete PI. See 21 C.F.R. § 201.100(d). However, as anyone who has ever reviewed the PI for a drug can tell you, this information is far from “brief” or consumer-friendly. The font is tiny, the language is often highly technical, and it is clearly not designed for lay use.
In the revised draft guidance, FDA acknowledges recent social science research indicating that current methods of fulfilling the requirements to disclose risk information in print media are largely ineffective. When exhaustive lists of all possible adverse events are listed in a small font using highly technical language, consumers may not comprehend the most important information or even bother to read the material at all. The revised draft guidance attempts to remedy this problem by assuring firms that if they adopt one of two alternate approaches designed to simplify the presentation of risk information, FDA will not object. The revised draft guidance also offers suggestions for how to make the presentation of risk information user-friendly and outlines some general requirements for how this important information should be presented in a “consumer brief summary.”
User-Friendly Language
First, FDA encourages companies to make the consumer brief summary more accessible. Companies should use “consumer-friendly” language that can be understood by a broad audience with varying literacy skills (e.g., “do not use if you have . . .” or “who should not use . . .” rather than “contraindications”). Overly technical language and medical jargon is discouraged. The consumer brief summary should employ signals such as headlines and subheadings in order to guide consumers as they review it and ensure that they focus on the most relevant information. Companies should pay attention to details like font size and should carry over elements such as logos and branded colors to ensure that consumers understand the connection between the summary and the promotional piece.
Simplified Content
Second, in terms of content, FDA wants to ensure that the summary provides “clinically significant information on the most serious and the most common risks” associated with a drug instead of providing an exhaustive list of information. FDA encourages companies to look to available standards such as FDA-approved patient labeling and Medication Guides as a starting point for deciding what risk information should be included. Additionally, the “Highlights of Prescribing Information” as required by the final rule for Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products (21 C.F.R. § 201.56(d)(1)) are also an appropriate reference point for making this decision. Companies should keep in mind that more detail than is published in the Highlights may be required because the consumer brief summary will not be accompanied by the full PI.
Regardless of format, the consumer brief summary should provide information addressing:
- Boxed Warning, if applicable
- All Contraindications
- Certain information regarding Warnings and Precautions
- 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.
Additionally, the most frequently occurring adverse reactions should be listed in the same order as in the PI. If there is more than one indication, the most common adverse reaction for each indication promoted should be included; the piece should not include pooled adverse reactions for all indications. Serious adverse reactions or reactions leading to discontinuation of the drug or a dose adjustment should be listed unless they are repeated elsewhere. Material information on risks should also be included. For example, what are the early warning signs of a known risk?
The summary should also include the indication for the use being promoted, any clinically significant interactions, and information on any topics consumers should discuss with health care providers. Finally, companies should consider if other information such as special information relevant to specific populations (e.g., children, the elderly, pregnant, or nursing women), should also be included. Dosing and administration information and other specific directions in the FDA-approved labeling need not be included. However, because the risk information in the consumer brief summary is not comprehensive, there should be a statement warning consumers of this fact and reminding them to speak to a health care provider or pharmacist if they have questions. A toll-free number or website address where consumers can obtain the FDA-approved labeling should also be provided.
User-Friendly Formatting Options
Finally, the revised draft guidance describes two possible options for formatting a consumer brief summary in a more user-friendly manner. The first is a familiar format that has been shown to be effective. Under the revised draft guidance, FDA now suggests that firms create a Prescription Drug Facts box that is similar to the OTC Drug Facts box. Risk information could appear in a box and standardized headings could assist consumers in focusing on the important information. The guidance suggests the following headings:
- Uses
- Do not use if
- Warnings
- Ask a health care provider before use if
- When using this product you may have
Alternatively, a Question and Answer format can also help consumers understand the most important drug information. Under this suggested format, the headings would take the form of questions. For example:
- What is [drug] used for?
- When should I not take [drug]?
- What Warnings should I know about [drug]?
- What should I tell my health care provider?
- What are the side effects of [drug]?
- What other medications might interact with [drug]?
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