This week at the Food & Drug Law Institute's Advertising & Promotion Conference, FDA made a subtle, but vital, clarification in the context of discussing the scope of its guidance on space-limited contexts.
The clarification came on the penultimate slide* of FDA's presentation about the space-limited and correcting misinformation guidances. On that slide, and during that portion of the corresponding presentation, FDA noted that the guidance explicitly set aside any discussion of reminder advertising, and addressed the prohibition for use of the reminder ad format by sponsors of black box drugs.
FDA then proceeded to note that although reminder advertising and promotion is prohibited for black box drugs, the FDA has long recognized in traditional (i.e., offline) communications the ability of sponsors of black box drugs to engage in "reminder-like" promotion.
The key distinction for reminder-like promotion vs. reminder promotion is that reminder-like promotion must have an"[a]ccompanying PI or brief summary" and a statement to "Please see..." the accompanying PI. Reminder promotions do not have such requirements.
At this point, it's useful to briefly recap the traditional reminder advertising/promotion requirements:
As I discussed in my article on search engine marketing, traditional reminder advertising has only a few required elements:
- brand name (if any)
- generic name of the product and/or active ingredients
All other elements are optional. Quoting directly from my article, the optional elements are:
- quantitative ingredient statements (e.g., 20 mg)
- dosage form (e.g., tablets or capsules)
- quantity of package contents (e.g., 30 pills per bottle)
- name and address of the manufacturer, packer or distributor
- other information so long as it makes “no representation or suggestion” about the product use
So, FDA is acknowledging this week the existence of a separate category of communication with a distinct set of requirements. For reminder-like promotion, the required elements appear to be:
- Brand name (if any)
- Generic name of the product and/or active ingredients
- "Please see..." statement directing people to the PI or Brief Summary
- Provision of a PI or Brief Summary immediately accompanying the advertisement
This presentation was a welcome clarification for many reasons. Perhaps the most important reason is that many people in industry have been concerned that FDA's guidance provisions make it impossible for sponsors of black box products to engage in communication channels with space limitations.
Second, many of the communications that seem most appropriate in social media, and other space-limited contexts would most likely make use of formats that fall under the category of reminder or "reminder-like" communications, such as sending a Tweet to a customer who is asking where she/he can find information about the most common side effects associated with a drug.
There are, though, still many questions to be answered about these "reminder-like" communications. Among those that leap immediately to mind are:
- What are the rules about what you may or may not include in a reminder-like promotion?
- Are you permitted to include all of the same information in a reminder-like promotion as in a traditional reminder ad for a drug without a black box?
- Are there any additional requirements for the reminder-like ads beyond the link or physical accompaniment of the prescribing information?
- When engaging in reminder-like promotion online, must the link to the PI be a direct link, or would it suffice to have a link to page where a link to the full PI is presented along with additional information?
- Is it permitted (or required) to mention that the product has black box warnings in the reminder-like promotion?
- If either, is there specific language that should be used to describe those warnings?
These last few questions are particularly important for the context of space-limited contexts explicitly addressed by the guidance because the current Google Black Box ad format makes use of the following phrase, which sponsors are not permitted to alter:
"Click to see full safety and prescribing information, including boxed warning. More info"
Many people (including me) think that this language is confusing in consumer-directed promotion because consumers probably aren't familiar with either a PI or the phrase "boxed warning."
So, although that language is appropriate for HCP advertising, it seems as if a more consumer-friendly version should exist.
For example, "Click to see full product benefit and risk information, including all serious warnings. More info"
I hope this recent presentation by FDA furthers the conversation about how sponsors of black box products can make use of space-limited contexts while remaining compliant with FDA promotional regulations.
* Note that I'm not sure whether the slides will be available for non-FDLI members and non-conference attendees. There does not appear to be any log-in requirement to access this link. FDA generally makes their public presentations available, so if the link is blocked for any users, contact me and I'll let you know when FDA posts the presentations.