Feb. 9, 2015 – In a revised draft guidance document released Feb. 6, the FDA is updating a 2004 version that covers brief summary requirements for consumer-directed print drug ads by calling for standardized formats that are easier for consumers to read and understand and recommending that drug firms do not disseminate the full, FDA-approved package insert (PI) to fulfill the adequate directions for use requirement for direct-to-consumer (DTC) ads (ucm069984).
“While a long time in the making, this draft guidance follows both the research and the common sense of making the print brief summary both relatively brief and more useful to consumers,” said Coalition for Healthcare Communication Executive Director John Kamp. “The guidance moves the regulation of DTC print much closer to the realities of consumer perception,” he said.
Specifically, the new draft guidance states that FDA “believes that the brief summary should focus on the most important risk information rather than an exhaustive list of risks and that the information should be presented in a way most likely to be understood by consumers.” Accordingly, the agency “strongly recommends” that companies not use the “traditional approach” in which risk information is pulled verbatim from the PI, often in a tiny font, in order to fulfill the brief summary requirement.
“Because the target audience of the PI is health care providers, it is written in highly technical medical terminology, which is potentially of limited value to consumers who may not have the medical or scientific background to understand this information,” the draft guidance states. The agency also provides social research results supporting its conclusions and adds that the “exhaustive lists” of risk information in the PI are hard for consumers to comprehend or retain.
The draft guidance offers firms “options for disclosing risk information” in print DTC ads, and states that “FDA does not intend to object if a firm does not include ‘each specific side effect and contraindication’ from the PI in the brief summary.” In lieu of the PI, the agency would prefer a “consumer-directed document” that it refers to as a “consumer brief summary.” This summary would offer consumers risk information in a standardized format and include only “the most serious and the most common risks associated with the product, while omitting less important information,” a Feb. 9 notice in the Federal Register states (2015-02527).
The FDA “recommends that any Boxed Warning, all Contraindications, certain information regarding Warnings and Precautions (i.e., the most clinically significant information from the Warnings and Precautions section 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 the taken to prevent or mitigate harm), and the most frequently occurring Adverse Reactions should be included.”
The agency also recommends that the information provided also include the indication for the use being promoted, patient directives (such as “discuss with your health care provider any pre-existing conditions” or “tell your health care provider if you are taking any medications”), as well as other types of information that are relevant to the drug or specific indication referred to in the promotional material.
Further, because the risk information in the consumer brief statement is not comprehensive, the summary should include a statement: “(1) reminding consumers that the information provided is not comprehensive, (2) suggesting that consumers speak to their health care provider or pharmacist, and (3) containing a toll-free telephone number or website address … where consumers can obtain the FDA-approved product labeling.”
In terms of format, the new draft guidance recommends “formats that have been tested in research,” which include a “Prescription Drug Facts Box” format (similar to those used for over-the-counter drugs) and a “Question and Answer” format.
The FDA is accepting comments on the new draft guidance until May 11, and specifically requests comments on the following issues:
- In the revised draft guidance, FDA provides recommendations regarding the content and format of the consumer brief summary. Is this the most useful information for consumers to use in determining whether to take a medication or seek more information about a product, and if not, what information would be more useful?
- FDA is also interested in relevant research that has been conducted or alternative formats that were developed after we received comments on the 2004 draft guidance.
- In the revised draft guidance, FDA suggests that the adequate directions for use requirement be fulfilled by providing the consumer brief summary rather than the full PI for the product. FDA seeks comments regarding this recommendation.
For additional commentary on the new draft guidance, see this post in Pharma Marketing Blog: http://pharmamkting.blogspot.com/2015/02/disclosing-risk-in-dtc-print-ads.html