DTC Perspectives Article Out Now

Apologies for the lack of posting.

It's been a busy few months. I have, however, been writing, just not posting stuff to the blog. Some of the writing is for a longer book project.

I did, though, publish a column over at DTC Perspectives giving my take on what I have dubbed "Social Media Guidance Year." This of course comes on the heels of the new national holiday, June 17, which shall henceforward be known as Social Media Guidance Day.

Check it out: http://www.dtcperspectives.com/dtc-news/social-media-guidance-year.html

Master Class Early-Bird Discount Expiring Soon!

There are still spaces available in the November 12 & 18 sessions of Using Social Media Compliantly in Princeton, NJ, and Boston, MA, respectively.

These classes will go beyond the information presented in my recent articles (available here and here) about the FDA guidances, and focus on the key decisions that need to be made on the top three platforms (Facebook, Twitter, and YouTube) to use these platforms compliantly.

Right now, there is a $100 early-bird discount available, but that is about to expire, so if you're interested in attending, register now!

"Reminder-like" Promotions

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:

1. brand name (if any)
2. generic name of the product and/or active ingredients

All other elements are optional. Quoting directly from my article, the optional elements are:

1. quantitative ingredient statements (e.g., 20 mg)
2. dosage form (e.g., tablets or capsules)
3. quantity of package contents (e.g., 30 pills per bottle)
4. price
5. name and address of the manufacturer, packer or distributor
6. 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:

1. Brand name (if any)
2. Generic name of the product and/or active ingredients
3. "Please see..." statement directing people to the PI or Brief Summary
4. 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.

Podcast with PharmaGuy

I was interviewed for PharmaGuy's podcast today. One of the primary topics was the FDAnews Ad-promo workshop that I'm teaching October 15-16. It was a fun time, and here's the archive.

  

Check Out Business Podcasts at Blog Talk Radio with Pharmaguy on BlogTalkRadio

New Speaking Engagements

I have accepted an invitation to speak at the DTC Point of Care Conference on October 1st in Baltimore. Mukesh Mehta of PDR and I will be talking about the explosive growth in EHRs and the need to engage this new communication channel compliantly for providing patients the information they need while ensuring compliance.

Also, I have partnered with FDAnews to prepare a two-day workshop for ad/promo professionals. This workshop will present the basic principles that apply to all promotional communications. In addition, I'll be focusing on some of the areas that have been subject to recent clarification and guidance, including social media and product name usage.

FDAnews is offering a discount exclusively to readers of this blog. To get the details, fill out the contact form in the right rail and ask me for the discount code.

An Underutilized Phrase in SEM?

I suspect that "FDA-approved," "FDA-cleared," "approved by the FDA," and similar phrases are not fully appreciated by marketers of prescription products.

There is a tendency of marketers of prescription products to put on their blinders and see themselves and their product's performance solely in the context of other prescription products. Who's one slot above us on the IMS Health Rankings and who's one slot below? Are we gaining or losing ground?

But for consumers (and even HCPs for certain conditions), the decision set (your actual competitors in the marketplace) include many non-prescription, and even non-drug treatments. Dietary supplements, homeopathic remedies, and even home cures are legitimate considerations for treating many conditions, and many consumers don't distinguish between all of these categories as rigidly as people in the pharmaceutical industry.

However, the public in general holds the FDA in high esteem, and though criticism of the FDA certainly exists, most consumers consider the fact that the FDA has reviewed and approved (or cleared) a product as a guarantee of the product's quality and overall safety.

As such, the phrase "FDA-approved" can have significant value in a context (such as search engine marketing results), where the competition includes many products that are not reviewed, approved, or cleared by the FDA.

As part of FDAMA's passage in 1997, the prohibition on using this phrase was removed from the FD&C Act.

Since the implementation of FDAMA, FDA has not taken any actions for including the phrase "FDA-approved" or its variations in what otherwise would qualify as a reminder ad, and although FDA has never explicitly endorsed the phrase as being compatible with the reminder ad format, it certainly seems to qualify.

A reminder ad may not include any "representation or suggestion relating to the advertised drug product." 21 CFR 202.1(e)(2)(i) And the phrase "FDA-approved" certainly does not seem to violate that prohibition.

Redirecting Ads

Updated slightly to correct grammar and spelling, and to improve clarity.

In my article and presentation about search engine marketing for pharmaceutical products, I talk about a category of communications called Redirecting Ads.

These ads have the following characteristics:

1. The ads link to a product site
2. Do not mention a specific product
3. Do not imply a specific product

There were many such ads present in the violative materials posted by the FDA in its 2009 enforcement action about paid search, but none of the ads were cited by the FDA as violative. Given that the FDA went out of its way to take such a massive enforcement action and made clear in subsequent statements that this was intended as a clear statement to industry about what was considered unacceptable in this vital medium, it seems clear to me that FDA's silence on Redirecting Ads was deliberate.

The meaning of the silence is debatable. Did FDA think that such ads were outside its purview (this is my view, BTW)? Did FDA think that such ads were unimportant? Did FDA believe these were not prominent enough to merit inclusion in the enforcement action? Did FDA not want to muddy the waters by including Redirecting Ads? Or was it some combination of these different factors? We don't know, and FDA hasn't said anything.

The reason such ads are important (indeed, I would say vital) to people making use of social media is that it can be difficult to include all of the information that FDA requires in a product promotion in certain space-constrained social media platforms. Redirecting Ads avoid the need for meeting all of those requirements by essentially asking people to go to a separate destination where the sponsor CAN meet those requirements.

There are, however, more questions about how to use such an ad format correctly and compliantly. We know from FDA enforcement actions in the past that simply omitting the brand and generic name from an ad does not mean that the ad is considered not to be a product promotion.* That's why I include the characteristic that Redirecting Ads also do not imply a specific product. How though do you avoid such implications?

One clear means of implying a specific product would be via description. You could, for example, state that the ad was for Pfizer's treatment for erectile dysfunction and without ever mentioning the product name, everyone would know which particular brand you were talking about. In the context of HCP-targeted communication, describing the mechanism of action for a product might be another way to clearly identify the product if only one such product exists.

Additionally, some tag lines or other brand assets have developed a prominence and a life of their own to such an extent that simply using the phrases that have become identified with the product constitutes a mention of the brand name or an implication about which product is being discussed. In this context, it is interesting to note some recent television advertising has been running without having received any FDA enforcement action. This advertising clearly leverages brand assets that are identified with a specific product, but nowhere in the ad is the product name mentioned.

I'm glad there is an ad currently running on TV doing this because regardless of this specific execution, it highlights that Redirecting Ads might be vital to social media, but they are in no way limited to social media. Indeed, this advertising format is frequently used in other product categories, such as teaser campaigns for movies, which do not reveal the exact nature of the product in the teaser communications themselves, but instead send people to another location (whether to visit a website or to call a phone number) to learn more.

One of the downsides to Redirecting Ads is that it unfortunately is also a technique used heavily in some of the less savory areas of online advertising and promotion. Indeed, that's one reason that some publications produce lists each year of the "most dangerous celebrities to search" because people pushing malware and viruses attempt to lure visitors by promising one experience in their search campaigns and then directing to other locations.

Recently, I have faced the question of whether Redirecting Ads are inherently limited because their success brings about the end of their utility. 

For example, assume a sponsor of Brand X becomes enormously successful running a Redirecting Ad that reads, "Check out www.conditionXtreatment.com to alleviate your worst pain."

The more people click on the link and see the ad (which by definition explicitly discusses a specific product by name and meets all of the requirements for being a product promotion), the more they begin to associate both the website "www.conditionXtreatment.com" and the phrase "alleviate your worst pain" with Brand X. So, does there come a point where using either of those pieces of content becomes synonymous with using the name Brand X itself, and thus the ad that is intended to avoid mention of the product begins to be viewed as implying a specific product and thus violating the third condition for a Redirecting Ad?

It might. Indeed, there are brands whose taglines and marketing messages are probably better known than the brand name itself, but I suspect this problem would only arise after a Redirecting Ad campaign has been in the market for quite a while and thus marketers could feel confident in investing in such campaigns, though they will have to keep an eye out for when the proverbial Rubicon has been crossed.

* Yes, I do realize how convoluted this sentence construction is, but I also think it's necessary to make the point this way.