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Regulatory News | 06 February 2015 | By Alexander Gaffney, RAC
The pharmaceutical advertising you see in magazines and newspapers will soon include less information in the hopes of better conveying what the actual risk of the drug is, the US Food and Drug Administration (FDA) announced today.
The change represents a substantial shift in policy for the agency, which has traditionally favored the inclusion of as much risk information as possible in its advertising. For example, FDA's Office of Prescription Drug Promotion (OPDP) frequently sends out "Untitled Letters" warning companies about the omission of risk factors in their printed promotional materials.
Editor's note: A previous version of this article implied that FDA's new approach to presenting risk information would apply to the "main body" of the advertisement itself. That is incorrect. The policy only applies to information accompanying an advertisement, which has traditionally included the full prescribing information (PI) for the drug.
But as Regulatory Focus has previously reported, recent notices issued by FDA have indicated that the agency is in the midst of a refinement in its advertising regulatory strategy. Since 2012, FDA has announced at least 11 studies on how consumers understand drug advertising, including on whether direct-to-consumer advertising
should contain only the "major risks" associated with a drug.
Read more about FDA's DTC drug advertising studies in our Regulatory Tracker here.
At issue for FDA: While they want to ensure consumers are made aware of the risks of a drug, listing too many risks can make an otherwise safe drug sound just as dangerous as a drug that isn't safe. That can leave consumers confused, and even prompt them to avoid starting life-saving treatments.
Other consumers might simply ignore the risks of a drug advertisement altogether if they are listed alongside a lengthy list of potential problems.
Now FDA has announced a new approach toward print—not television—drug advertising.
Their new draft guidance document,
Brief Summary and Adequate Directions for Use: Disclosing Risk information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs, will allow drug companies to adopt an approach FDA calls the "Consumer Brief Summary."
FDA said the change toward requiring less—though still sufficient—information in DTC advertising would "provide better and more actionable information for consumers."
"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," the agency wrote in its draft guidance document.
Perhaps the most interesting shift observable in FDA's guidance is that it doesn't simply shift away from its existing approach—it practically disowns it.
"FDA strongly recommends against the use of the traditional approach to fulfill the brief summary requirement in consumer-directed advertisements, an approach in which risk-related sections of the PI are presented verbatim, often in small font," it wrote. The current listing of information is "of limited value to consumers," since most of that information is written with physicians and healthcare providers in mind, FDA wrote.
Currently, many drug companies list all drug risks alongside their print advertising to ensure compliance with FDA's regulations. The omission of any risk information can sometimes result in FDA issuing so-called "untitled letters" to the companies demanding corrections be made.
The problem with this approach, as FDA explained, is that nearly half of all consumers (40%) admit that they "do not usually read any of the brief summary in DTC prescription drug print advertisements."
While FDA "does not plan to object" if companies continue to list the full prescribing information in the drug advertisement, neither will it object to companies who wish to use "consumer-friendly language" in their DTC print advertising aimed at consumers.
"The consumer brief summary should be written in language designed for understanding by a broad target audience with various levels of literacy skills," FDA wrote, adding that it envisioned a more "conversational tone" in describing the risks of a drug.
For example, drug companies are encouraged to use phrases like, "Do not use if you have" or "Who should not use" rather than, "This use is contraindicated in…"
Companies may also use different content layouts and subheaders to present information, FDA wrote. FDA said it would permit anything using a "readable format," and recommends companies either use a question-and-answer format ("When should I not take this drug?") or a "Drug Facts Box" format.
So which risks will be contained alongside the DTC advertisements? FDA said it wants "clinically significant information on the most serious and the most common risks associated with the product."
"Less pertinent information" should not be included, the agency added.
But that language raises a question: How does one define "clinically significant" or "pertinent"? FDA's guidance isn't entirely helpful on this point. FDA notes that any information that would be included within a Medication Guide—used to highlight the major risks of a drug—should be included, but it also mentions that not all information in those guides needs to be included. Information within the "Directions for Use" section, for example, might not need to be included.
The guidance calls for "alternative formats" to address any boxed warnings, all contraindications, and information about the "most clinically significant information from the Warnings and Precautions section," information that would "affect a decision to prescribe or take a drug," any special precautions or risk-mitigation measures.
The most frequently-occurring adverse events should also be included.
For drug companies, the guidance may raise more questions than it answers. Faced with the difficult choice of deciding which drug risks are or aren't clinically relevant might prove to be difficult and risky from a regulatory perspective. Any omission, however small, might result in an untitled letter from FDA.
The guidance, for example, doesn't contain much detail on which information companies can definitely exclude from their drug advertising.
However, it does call for any company that does omit information to list a statement on the advertising explaining that the "risk information provided here is not comprehensive," and to visit the drug company's website to access the full prescribing information (PI).
Comments on FDA's new approach are being accepted for 90 days.
Brief Summary and Adequate Directions for Use: Disclosing Risk information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs (FR)
Tags: DTC Advertising, FDA Regulation of Advertising, Pharmaceutical Advertising, Drug Advertising, Guidance, Draft Guidance, OPDP