WTA?

Disclosure: I sit on the Google Health Advisory Board, and Google has been a client of PhillyCooke Consulting. Nothing in this post has been shown to Google or received the endorsement or approval of anyone at Google. I have discussed the topic of this post with Google employees.

"Why this ad?" (WTA) functionality has suddenly become hot news in the pharmaceutical industry. For those of you who have not noticed it previously, or heard the hubbub, here's the deal.

Google takes transparency quite seriously, and given the privacy concerns everyone has about trusting any company with as much information as Google maintains on people, it's understandable why.

As part of its transparency efforts, Google added some new functionality to its search engine marketing (SEM) results a few years ago. Users are able to learn why a particular ad is being presented to them.

In practice what users see is a symbol (either an encircled letter "i" or a green triangle) next to a promoted message.

The red box surrounds the symbol in mobile and desktop search results that
enable the user to learn more about the ad targeting.

Users who click on the symbol see a question appear, "Why this ad?"

These images show the "Why this ad?" popup that users see after clicking on the symbol.

Clicking on the question prompts a further box to appear with information about why that particular ad was displayed to the user.

There are differences between the functionality in a desktop/laptop and a mobile environment. For example, in the mobile environment, the shadow box effect obscures and separates the underlying ad from the information supplied by Google more than the overlaid box alone that is seen on a laptop.

Both mobile and desktop ads display the root URL of the destination from the ad at the top of the box, and both allow signed-in users to opt out of seeing ads from that URL via a slider at the bottom of the box, which again displays that root URL of the destination webpage.

The reasons provided for what the ad is based on will vary depending on what caused the ad to appear. The factors listed in SEM ads will always include the search terms and might also include factors such as location (if the user permits Google to access that information) or that the user has previously visited the site.

The WTA information and functionality is not advertising content. No advertiser is permitted to alter this content or has any control over it. Advertisers indirectly influence it via the parameters that they set for determining when their ads appear. For example, if an advertiser targets only users who have previously visited their website, then that factor might appear, whereas if the targeting is solely based on the search terms, then it would be less likely to appear.

Some people have recently learned about this functionality and raised questions about whether it poses a potential risk for violating the Food and Drug Administration's (FDA) advertising regulations.

The scenario these people envision is that a company is using a redirecting ad, which by definition doesn't include the brand name in the ad itself but instead redirects users to a Brand.com website. If a user sees such an ad and clicks on the WTA symbol, and then clicks a second time on the "Why this ad?" popup, the user will see the brand name appearing because the brand name is most often the root URL of the home page for the destination of the redirecting ad.

The FDA has made clear via previous enforcement actions (such as many of the infamous 14 search letters from 2009) that merely using the brand name in a URL is considered by the FDA to be a mention of the drug for the purposes of advertising the product, and carries with it all of the requirements associated with any other product name mention.

Depending on the type of ad, the requirements might include only the inclusion of the brand and generic names and the relative sizing of the two, or they could be as extensive as the inclusion of the complete indication statement, dosage form, etc., associated with a full product promotion.

Let's first address the idea that a company could be out of compliance because the brand name of its product appeared without the generic name. The brand name is appearing in a location over which the company has no control. As mentioned earlier, the popup box is not itself an advertising unit. Companies cannot ask Google to change the information that appears in the box, and they have no control over it. There is some indirect influence, but this is definitely not a company-owned or company-controlled communication. Consequently, it would seem that this appearance of the brand name would be analogous to a newspaper using the brand name, and newspapers frequently use the brand name of drugs without including the generic name. 

FDA would never take enforcement action against a company for that type of third-party action, and it is hard to imagine that they would do so here.

Then there's a second issue. Depending on whether a user is accessing the ad via a mobile device or a desktop computer, the user might be able to see the underlying ad at the same time as the overlay. It is certainly possible that this could mean that a user sees both the brand name and some of the underlying redirecting ad, which was so carefully designed by the company to avoid including the brand name. In some cases, there is information in the redirecting ad that would be considered by the FDA to describe the product's use. And in that same set of infamous letters from 2009, FDA made very clear that including some description of a product's use with the brand name carries with it the full requirements associated with a complete production promotion (indication statement, etc.).

Does that pose a risk of FDA enforcement? 

For FDA to take an enforcement action in this instance, FDA would have to hold a company accountable for a message over which it has complete control (the underlying redirecting ad) when that message is combined with a separate message over which the company has no control.

It seems hard to believe the FDA would do something like that.

I admit that I would be happier if the WTA overlay box behaved the same way on a desktop as it does on a mobile device, with the shadow box effect that obscures the underlying ad and that also makes the separation between the two communications more clear.

But even without this change being implemented, I see an extremely low risk that FDA would take an enforcement action for an advertising publisher creating a tool that reveals more information than an advertiser wanted included in their ad.

While Google is determining what (if any) changes to make to its WTA functionality in light of the latest stir, I would submit for all of the reasons above that this poses a low risk of enforcement.

FDA's One-click Study

At the beginning of November, FDA announced its intention to conduct a study looking at the so-called "one-click rule." As readers of this blog know, I've termed this, "The 'Rule' That Isn't."

The basic idea behind any version of the one-click rule is that companies can meet their fair balance requirement (21 CFR 202.1(e)(5)(ii)) by including a hyperlink to the risk information, rather than by providing the risk information itself in the original communication. As I've written about previously, this idea has had significant allure for marketers of prescription products but there has never been any indication from the FDA that it was open to it...until now.

I have been working with a few different clients preparing comments on the study proposal outlined by the FDA. Those will be posted to the docket and available for public view at a later date.

In this post, I wanted to take a step back and look at what this study means (and what it doesn't mean) for the immediate and future use of space-limited contexts by prescription product manufacturers and FDA guidance about this issue.

In 1998, FDA took its first enforcement action for Internet marketing. At the time, the FDA noted that "the link to the full prescribing information alone is insufficient to meet the requirements...that advertisements contain fair balance."

This began an 18-year history of the FDA making clear that it did not acknowledge a one-click "rule." This position was further solidified via FDA's 2014 guidance on space-limited contexts (the so-called "Twitter Guidance") that directly addressed the use of Twitter and search engine marketing formats that explicitly limit the number of characters. In that guidance, FDA asserted, "Regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication." This is as explicit a rejection of any version of a one-click rule as FDA could possibly have made.

Just one sentence earlier in the guidance, FDA further asserted that, "If an accurate and balanced presentation of both risks and benefits of a specific product is not possible within the constraints of the platform, then the firm should reconsider using that platform for the intended promotional message (other than for permitted reminder promotion)."

Combined, these two statements established a framework that FDA was explicitly acknowledging could not be used by some manufacturers of prescription products for making claims about the benefits of their products. The consequences of this framework is that in certain contexts only products not subject to FDA's fair balance requirement would be able to provide benefit information about their products.

Of course, "benefit" information includes any suggestion of the product's indication. In practice, this means that prescription products manufacturers are frequently prevented from letting people know that their product(s) are possible treatment options for them; and that FDA's official position, as expressed in the 2014 guidance, is that this is fine.

Many people objected to this aspect of the draft guidance (see, for example, the comments from PhRMA), and that resulted in a brief movement to include a version of the one-click rule in the 21st Century Cures Act.

In that context, FDA's openness to studying these issues is a major step forward. Rather than simply assuming without any evidence that the public is harmed by companies following some version of a one-click rule, FDA is actually studying the issue.

This positive development is balanced, however, with the study design itself. In the proposed study, FDA is comparing a format that makes use of a one-click rule with a format that follows the recommendations from the 2014 guidance. One problem with this study design is that it is comparing a format that the FDA has acknowledged is not available to all product manufacturers because of the nature of their specific indications and risks. Indeed, I'm not aware of a single company that has attempted to use the format FDA demonstrated in that guidance for Google search or a Twitter ad.*

In addition, although FDA's willingness to study this topic is refreshing, the study announcement coming late in 2016 would seem to indicate that the status quo will remain for several years. It has been more than a year since FDA has released any new or updated guidance related to advertising and promotion (the last one was a minor revision in August of 2015), and the existing FDA guidance on space-constrained contexts has some glaring issues, independent of the position on one-click.

Taking a generous view of FDA's speed in fielding this research, it would be difficult to imagine that the final study results would be available before the end of 2017. FDA absolutely takes the work of its research team into account in developing guidance, including the ad-promo research. That probably means that the earliest we would see any update to the 2014 guidance would be 2018.

That's four years after FDA released the draft guidance and nine years after the 2009 hearings. FDA can't be expected to provide guidance that keeps up with the pace of technological change. Indeed, I think that's a virtue rather than a drawback to FDA's approach. It's better to have guidance that lags slightly behind innovation rather than wasting time developing guidance on topics that prove to be mere flashes in the pan. Consider the wasted effort if FDA had developed a guidance dedicated to Sidewiki after its 2009 hearings.

This, however, is a very different situation. FDA's enforcement activity related to its rejection of any version of the one-click rule has spanned nearly 20 years. Throughout that time, marketers of prescription products who want to inform the public about how they can help have been hindered in the ability to make that information available in the platforms that people are showing they prefer. And only now is FDA announcing its intention to see whether that position has any basis in actual experience. 

* If anyone is aware of such an ad, please share it in the comments or via the contact form in the right rail.

Google's Latest Ad Format Update

Google recently announced a change to its standard ad unit. This marks the third significant change affecting marketers of prescription products in the past year who are using Google.

At this point, I'm definitely seeing the need to revisit my article on using Google to market prescription products and even the presentation from last fall's FDLI Advertising and Promotion conference is now out of date. Over the next few months, I will be providing more on that.

In the meantime, here's the skinny on the update.

Google is fully embracing a mobile-first world view and is expanding the character count limitations for text ads.

The chart below (lifted from Google's public blog post) shows the breakdown between the current and the new formats.

For the ad copy, an additional 35 characters will be available for the headline, and an additional 10 characters will be available for the description. As pointed out by Convergence Point Media, in practice, this might expand the total characters available in a description even more than 10 characters because the description will no longer be treated as two separate 35-characters fields. That might mean that marketers are able to avoid the waste that sometimes is entailed in the current two-line description.

The primary benefit for marketers of prescription products is that it will be easier to meet their requirements for promoting drugs without a black box via a reminder ad and for black box drugs to fit all of the required elements for a reminder-like ad. This is most particularly relevant to fixed dose combination products. When the product being promoted has four or five active ingredients, it can very quickly be difficult to fix everything into the current character count limitations. Yet, failure to use the full established name remains on FDA's radar both in guidance and enforcement as a key regulatory requirement.

In addition to this expansion of the character counts, the display URL will be treated differently. Currently, marketers are able to manually enter a distinct display URL for their ads. In the new ad format, the display URL will be "automatically extracted" from the destination URL, with some (but only minimal) ability to customize the display URL seen by users.

This change has far greater implications for prescription product marketers, as it is precisely the ability to have a difference between the destination and the display URL that enables marketers to make use of redirecting ads.

If the ads automatically extract the base URL from the destination URL, then the mismatch between display and destination URL that is essential to redirecting ads will no longer be possible. This would significantly limit prescription product marketers' options. 

The biggest concern is for smaller, less well known brands. For those brands a reminder ad is not viable because very few people are already aware of their brand name; hence a reminder ad that doesn't describe the product's use has no value. But if the redirecting ads are eliminated, then such lesser known brands would have no way of attracting people who are looking for treatments. By assumption, these brands are not as well known which also means that their organic listings are not likely to be very high, so this would have a deeply chilling effect on the information available to people using Google. In essence, Google paid search would no longer be a viable means for building brands, but only for maintaining brands built on other platforms.

At the moment, Google has not provided any information about when this update will move beyond its initial testing to be available for everyone, or when it will be mandatory that ads adopt this new format. For now, this is simply something that marketers and regulatory professionals will need to stay abreast of.

It is also important to note that Google isn't synonymous with search, though it is the largest platform by a significant margin. Yahoo! and Bing remain very large players in this arena, and there's no reason to assume that Yahoo! and Bing will automatically adopt Google's changes. As a practical matter, this will probably mean having multiple sets of paid search campaigns going through the review and approval process.

Google SEM Changes Update

In June, Google announced changes to the ways search engine marketing (SEM) would work for marketers of prescription drugs. The background on the changes and the full original update is available here.

Recently, Google has provided additional detail about the new vanity URL policy, some new options, and hard dates for implementation.

First a quick backgrounder (see the earlier post for a more extensive background).

Background

Google eliminated the black box ad format that was created in 2009, and it announced that changes would be coming to its policy on the use of redirecting URLs (aka vanity URLs) by marketers of prescription products. SEM ads that make use of redirecting URLs are one specific instance of a more general category of ad I call redirecting ads.

Redirecting ads are not limited to search engines, but they're featured very prominently in search engine marketing. The basic idea behind a redirecting ad is that the ad itself does not promote a prescription product, instead it directs viewers to another location (website, toll free number, etc.) where a prescription product is being promoted. Marketers of prescription products make use of them extensively in space-limited contexts, such as SEM, because it can be difficult to fit all of the required elements from a full product promotion into such contexts.

For SEM ads, marketers often have to use these ads because their only other option is using a reminder ad, and a reminder ad is by definition worthless if the person seeing the ad doesn't already know the name of the product.

So, the key features of a redirecting SEM ad are:

1. Does not mention or imply a specific prescription product
2. Provides a link to a prescription product website
3. Displays a URL that does not match the destination page URL

It's that third element (the mismatch between the display and the destination URL) that has caused Google some agita. Google has long had a policy that prevents advertisers from having a significant mismatch between the display and destination URL. Google has previously been making an exception to that policy for marketers of prescription products precisely because there didn't seem to be any other option for them when a reminder ad would not work.

June Announcement

In June, Google announced that it would be changing its exception to that policy. At the time, Google said that instead of permitting marketers to invent their own display URL, Google would limit marketers to just three options.

1. Use CompanyName as the display URL
2. Use CompanyName.com as the display URL
3. Use "Prescription treatment website" or "Prescription device website" as the display URL

Latest Update

Now, Google has changed those options. First, Option 1 is no longer available. The only possible display URL using a company's name is for the display URL to be CompanyName.com. Moreover, to use that option, the URL itself must be live and the advertiser must own the URL. It is important to note that although the DISPLAY URL will be CompanyName.com, the DESTINATION URL  (i.e., the page people land on when they click on the ad) is completely under the control of the advertiser and does not have to be the company's main website.

In addition, the display URLs available under Option 3 have expanded significantly. Whereas the June announcement mentioned only two possibilities ("Prescription treatment website" or "Prescription device website"), there are now six display URLs available in both English and Spanish. Those display URLs are:

1. Prescription treatment website
2. Prescription device website
3. Medical device website
4. Preventative treatment website
5. Prescription contraception website
6. Prescription vaccine website

In Spanish:

1. Sitio de tratamientos con receta
2. Sitio de dispositivos con receta
3. Sitio de dispositivos médicos
4. Sitio de tratamientos preventivos
5. Sitio de anticonceptivos con receta
6. Sitio de vacunas con receta

Again, just as was previously announced, manufacturers of prescription products will be able to choose any of these display URLs, but whereas "CompanyName" in CompanyName.com is a template that will be filled in with the actual company's name, the options above must appear exactly as presented.

Timing

In addition to this change in the number of options, and the Google text options, Google has also announced the timing for these changes to take effect. There are three timing deadlines to keep in mind. The first is now.

Marketers who choose to make use of the option to use CompanyName.com as the display URL can immediately begin doing so. There is no need to wait, but there's also no requirement to do that immediately.

The next milestone is February 1, 2016. Beginning on that date, all of the 12 display URLs (six in English and six in Spanish) will be available as possibilities for redirecting ads to use.

Finally, the deadline for transitioning to these new options is March 1, 2016. On that date, no ads that are running using customized vanity URLs will be able to run. All ads must switch over to either of the two options:

1. CompanyName.com
2. One of Google's 12 display URLs
1. Prescription treatment website
2. Prescription device website
3. Medical device website
4. Preventative treatment website
5. Prescription contraception website
6. Prescription vaccine website
7. Sitio de tratamientos con receta
8. Sitio de dispositivos con receta
9. Sitio de dispositivos médicos
10. Sitio de tratamientos preventivos
11. Sitio de anticonceptivos con receta
12. Sitio de vacunas con receta

Implications

Search engines are vital to people using the Internet looking for health information. Consequently, marketers cannot afford to ignore SEM ads, and since these changes have been announced, there is plenty of time to update SEM campaigns to conform to these new Google-specific guidelines, and it is worth emphasizing that as I write this blog post, there is no word as to whether Yahoo!, Bing, or other search engines will also be adopting similar policies.

Additionally, marketers and their regulatory counterparts will have to review these ads to determine whether they need to be adjusted beyond the change in URL to avoid the implication of a specific prescription product; and we will have to wait to see how users adapt to seeing multiple ads using the same words as their display URL for unique ads.

Google Search Engine Marketing Changing

Update: Google has announced additional details and specific timing for the vanity URL changes discussed below. You can read the full update here.

Google has announced two significant changes to the way paid search engine advertising works for pharmaceutical products.  The first change affects only black box drugs and will take effect beginning July 20, 2015. The second affects redirecting ads and will take effect in January of 2016.

Following some background on the history of FDA enforcement and how companies adjusted to those actions, this post explains the changes Google is making and explores their implications.

Background*

In March 2009, the Food and Drug Administration sent 14 letters for violative search engine marketing practices of 48 brands. Thirteen of these letters explicitly referred to SEM ads running on Google, while the last one actually cited organic search listings on Yahoo!, but everyone (including the FDA) acted as if those were SEM ads also.

The FDA identified four types of violations in its 2009 enforcement actions:
1. omission of risk information
2. inadequate communication of indication
3. overstatement of efficacy
4. failure to use the required established name

Omission of risk information means the ads did not include risk information. Not all prescription drug advertising is required to include risk information; however, if a product promotion mentions (or implies) a specific product and includes information about that product’s usage or benefits, it is required to include risk information to meet the fair balance requirement (21 CFR 202.1(e)(5)(ii)). This is the only violation that was cited in every letter, and thus the apparent trigger of this unprecedented simultaneous issuance of 14 letters.

Sample 2009 Violative SEM Ad

Inadequate communication of indication is familiar to readers of FDA enforcement letters and most often relates to the failure to make clear restrictions on the drug’s intended use. (21 CFR 202.1(e)(3)(ii)). For example, the paid search listing for Flomax included the phrase “Learn About Treating Prostate Problems.” According to FDA, that implied a broader intended use than contained in Flomax’s Prescribing Information, which states Flomax is indicated specifically for treatment of the signs and symptoms of benign prostatic hyperplasia. More than half of the drugs cited were found to have impermissibly broadened the indication.

Only one drug (Mirena) was alleged to have overstated efficacy by “failing to reveal that Mirena is only indicated for up to 5 years of use before replacement.”

Failure to use the established name refers to the inclusion of the generic (i.e., “established”) name of the drug. Forty-two of the 48 cited drugs failed to include the established name. For more on this topic, see here.

None of the ads cited by the FDA were compliant reminder ads, which are required to include only two elements:
1. Brand name (if applicable)
2. Generic name and/or active ingredient

In addition, reminder ads are permitted (though not required) by regulation to include:
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

Importantly, certain drugs with severe warnings, so-called black box drugs, are forbidden to engage in reminder ads. (21 CFR 202.1(e)(2)(i))

However, as noted previously on this blog, FDA has acknowledged the existence of a separate category of communications, which they call Reminder-like ads. Reminder-like ads share many of the same features of reminder ads, in that they are not permitted to make any representation about the use of the drug, but reminder-like ads have additional requirements.

A compliant reminder-like ad for a black box drug must include:
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

Following the FDA's enforcement activity in 2009, SEM ads for prescription drugs basically stopped. Then, industry regrouped and began running compliant reminder ads and/or redirecting ads.

Redirecting ads (a phrase I coined) have the following characteristics:
1. Nothing in the SEM ad mentions or implies a specific product.
2. The display URL redirects to a distinct destination URL.
3. The destination URL is a product-specific promotional website.

Sample Redirecting Ad from 2009 Enforcement Action--Not Cited as Violative

In addition, Google created a new dedicated ad format that was only available to marketers of prescription drugs with a black box. That ad format has an additional line of copy and a separate destination link.

Yaz was the first brand to use Google's black box ad format.

The dedicated line of copy reads, "“Click to see full safety and prescribing information, including boxed warning. More info." The words "More info." contain a separate hyperlink that takes people who click on it to a page dedicated to the presentation of risk information including the boxed warning.

Though the FDA has never directly addressed the Google black box ad format in any guidance or public statement, this ad format seems to fall within the scope of the reminder-like ads that the FDA has acknowledged are compliant.

Google's Changes

There are two separate changes to Google's policies regarding pharmaceutical company SEM ads.

First, Google is discontinuing the dedicated black box ad format. This will no longer be available for anyone.

This change will take place on July 20, 2015. Beginning that date, any ads using the black box format will no longer run.

Instead, all marketers of black box drugs will have to make use of the standard ad format without the additional dedicated line of copy and the separate hyperlink to a page dedicated to risk information.

While this is likely to upset many pharmaceutical companies, for most companies, it will be possible to develop a compliant reminder-like ad within the standard ad format for their black box drugs.

Sample reminder-like ad in standard ad format

Specifically, such ads will have to take advantage of the reminder-like ad format that FDA has acknowledged as being compliant. These ads will need to include the brand and generic name as well as a "Please see" statement directing users to the full PI including boxed warning.

The only open question in terms of FDA compliance is whether it suffices to have the accompanying PI be provided via a second hyperlink from the destination page as opposed to having a separate dedicated hyperlink in the original ad. The FDA's previous statements about the provision of a PI for reminder-like ads have been silent on this question (as noted here).

It is worth noting that in FDA's recent guidance about providing risk and benefit information in space-limited context, FDA considered it acceptable to provide the PI via a hyperlink from the destination page as opposed to having a separate dedicated link to the PI. (page 10)

Of course, that guidance did not directly address reminder-like promotion, and in fact, explicitly exempted all reminder ads from its scope. (see page 4 note 10)

Nonetheless, it is not too far fetched to believe that if the PI can be provided via a hyperlink from the destination page when the ad itself contains product benefit and risk information, then it would also be acceptable to have the PI provided in the same fashion for a reminder-like ad that does not contain any representation about a product's usage.

In addition, many companies currently making use of Google's dedicated black box ad format currently just provide a link to a webpage with risk information (not a direct link to the PI), and none of those ads have been cited by the FDA as being violative.

One benefit for pharmaceutical companies of this change is that the black box ad format never worked on mobile phones. That ad format was dedicated exclusively to desktop/laptop computers and larger tablets. Consequently, some black box drugs were already adopting the standard ad unit for their mobile campaigns making use of the reminder-like ad format without having the black box ad format available.

By being forced to adopt the standard ad format, marketers will be forced to adopt a format that is available on mobile devices.

Sample mobile ad for black box drug

The second change deals with the so-called redirecting ads. As noted above, these ads have been running without receiving any enforcement action from the FDA both before and after the infamous 14 letters of 2009.

FDA has never objected to marketers making use of this format, nor, so far as I'm aware, has FDA acknowledged that these ads exist. In previous discussions of these ads, I have speculated that the reason for this silence is that FDA does not clearly have any authority over these ads when done correctly because they do not explicitly reference or imply a specific prescription product.

I have also noted that this ad type is not in any way limited to SEM ads. Redirecting ads can be used on television commercials (for example, see this), billboards, print ads, or any other medium. The basic idea just is that redirecting ads do not themselves promote a prescription product. Instead, they direct people to another location (URL, telephone number, etc.) where they can see the ad for a prescription drug.

Google has long had a policy prohibiting ads where the destination URL differs dramatically from the display URL. Such advertising is not limited to the pharmaceutical industry, and while it is sometimes done by reputable, legitimate advertisers, it is also a practice that is shared by many unsavory practitioners. That is why Google has strictly forbidden it across the board, except for the pharmaceutical industry.

This exception was maintained because in many cases, the reminder (or reminder-like) ads discussed above don't seem appropriate. For example, if a user doesn't already know the name of my prescription drug, then a straightforward reminder ad might be at best worthless for the user who by definition isn't being reminded of anything since she isn't already aware of the product. And depending on the specifics of the case (for example, whether the user is aware that there are prescription treatment options for her condition, or whether prescription drugs frequently advertise without describing their uses), such a reminder ad might actually seem less appealing than other ads (for example, over the counter or homeopathic treatments that describe the product's name and use).

To reach such people, prescription product marketers have been using the redirecting ads, but beginning in January of 2016, Google will no longer permit advertisers to have vanity URLs (such as "PrescriptionTreatmentforConditionX.com") that redirect users to a website (e.g., BrandY.com) that promotes a specific treatment.

Instead, prescription product marketers will have three options for the display URL.

Option 1

They can simply display the company name as the display URL.

Sample ad showing company name as URL

Option 2

They can add ".com" to the company name.

Sample ad showing company name plus .com as URL

Option 3a (for prescription drugs, biologics, and presumably vaccines)

They can display the phrase "Prescription treatment website" as the display URL.

Sample ad showing prescription treatment display URL

Option 3b (for medical devices)

They can display the phrase "Prescription device website" as the display URL.

Sample ad showing device display URL

The only difference for marketers of prescription products between the new and the old redirecting ad formats is that there will no longer be any latitude in what display URL can be shown.

As noted earlier, the FDA has never commented officially in public on any of these ads, nor have any such ads been subject to enforcement action, so this change doesn't seem to face any immediate difficulties from the FDA.

There are, however, implications depending on which ad format is chosen. For example, one feature of the redirecting ad format is that the ad not only doesn't mention a product name, it also doesn't imply a specific product. FDA has taken enforcement action against products that made use of redirecting URLs when they deemed the ad itself to have implied (though not mentioned) a specific product.

So, in deciding which of the three options is the right one for a product, reviewers will have to consider whether inclusion of the company name or the phrase "Prescription treatment" (or "device") combined with the rest of copy implies a specific product.

It is also worth pointing out that this change by Google doesn't appear to have any obvious implications for the use of redirecting ads in other media (such as billboards and television). Google isn't preventing advertising from using URL redirects tout court. They can't do that. The only thing they can do is prevent advertisers from using certain redirecting URLs in Google paid SEM ads.

Conclusion

As a first step, marketers of prescription products will have to review all existing Google SEM ad campaigns. In some cases, these changes could completely stop all SEM advertising for a product (e.g., if a black box drug is only running the dedicated black box ad format) as soon as July 20. Most marketers, however, will face far less interruption. And for some marketers (those marketing products without a black box and not using the redirecting ad format), there will not be any changes at all.

Finally, it's worth noting that although Google dominates the search engine market, it is not the only player in town. Yahoo!, Bing, and others have their own policies, and it is dangerous to assume that everything Google does will be carried over to those other platforms. Individual campaigns will have to be modified to work across all platforms.

Given the immense importance of search engines, SEM is far too vital to fail to address these changes, and because people rely on search engines to find the information they need about their health, marketers have to make their information available via this channel.

* The following discussion draws heavily on my article about developing compliant search engine marketing from the September 2014 issue of Regulatory Focus. That article is now outdated, but I'll continue to keep it posted publicly here.

"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.

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.

Targeting a Competitor's Brand Name with Keywords

Although my article and presentation about search engine marketing included a lot of detail, there were some things that I didn't include.

One question that I frequently hear is about the propriety of targeting a competitive product name. In discussing this topic, I need to provide a disclaimer that I am not an attorney, and no advice from me should ever be construed as legal advice.

As for FDA compliance, I think it is perfectly OK to target a competitive brand with SEM ads depending on the type of ads and the way the targeting is conducted.

So, first a bit of background on keywords. From my recent article:

Keywords: Words entered into a search engine by a user. An advertiser identifies keywords that will trigger the appearance of their ad and places a bid for their preferred keywords. 

Negative Keywords: Words selected by an advertiser that will prevent their ad from appearing.

So, keywords and their negative keyword counterparts function analogously to a media plan in traditional media, but instead of buying publications that are read by 18-25 year-old women, an advertiser places an ad in front of people who are entering certain words into their search engine. As such, the same rules that apply to appropriate offline ad placement apply to what makes for an appropriate keyword.

That doesn't mean anything goes, but it does mean that we don't have to recreate the wheel to determine whether it's appropriate to use certain keywords. We simply apply the same principles from the offline world to the online practice.

So, with regard to disease awareness ads (these are ads that lead to disease awareness websites that do not themselves make any representation about a specific product), it is certainly OK to use the name of any product that is approved to treat the condition in question to serve up such ads.

Of course, if the product is being used off-label to treat the condition, then the advertiser might want to be cautious about the use of that keyword, but note that I would not automatically say that it is inappropriate even then.

For example, if a sponsor is currently investigating a product for an indication where there is not any FDA-approved treatments, and in the absence of any approved treatment, use of Product X has become the only resort for treating Condition Y, then a disease awareness campaign seeking to increase public knowledge about Condition Y might include Product X among its keywords, though probably only in conjunction with other keywords or negative keywords to try to target those people who are searching for information about treatments for Condition Y, rather than the audience of people who are searching for information about the approved indication for Product X.

Regarding redirecting ads, black box ad formats, and reminder ads, it would certainly be appropriate to target a competitor's product if both products have an identical indication or an identical population for at least one indication.

To see why, consider the following thought experiment. Imagine a breakthrough drug that creates an entirely new category of treatment. There is a long history of such medicines. Now, imagine a medical journal dedicating a special issue to the 10th anniversary of the approval of the first medicine in that category.

Would there be anything wrong with placing an ad for one of the newer medicines in that category in such an issue? For me, that answer is clearly no. So long as the newer medicine that is being advertised in that issue has the same indication (or a significantly overlapping indication) as the medicine that is the subject of the issue, then it would be OK to place the ad. The ad itself would have to be compliant, regardless of where it was placed, and that would mean that if the ad mentioned the competitive product that was the subject of the issue, then the claims would be comparative and in need of appropriate substantiation, but there's nothing inherently comparative in the placement itself.

The most common objection to such targeting is that such targeting can only be done if there is a head-to-head trial comparing the two drugs. I believe, however, that this conflates the content of the ad with the ad's placement. An ad whose content is not otherwise comparative in nature does not become comparative by virtue of placing it against a competitor.

In the case of a reminder ad or a black box ad, the compliant usage of such an ad format guarantees that there's nothing comparative in its content.

But what about the content of redirecting ads? Well, that's another blog post, and I'll address it tomorrow.

What constraints would I apply to targeting reminder ads or black box ad formats at a competitive product?

I find Venn diagrams the easiest way to explain the different scenarios:

Scenario 1: Product A & B have identical indications

In Scenario 1, Product A & B have identical indications. As I mentioned above, I think it's perfectly acceptable for either product to include its competitor among its keywords and deliver a branded advertising message via a reminder ad or black box ad to the users.

Scenario 2: Product B population is subset of Product A

In Scenario 2, everyone who is indicated for Product B is also within the indicated population for Product A. This can happen, for example, when Product A has an indication covering adolescent, adult, and geriatric populations for a condition, but Product B only has an adult indication. My view is that Product A can use Product B as a keyword to deliver branded messaging because by hypothesis everyone indicated for Product B is also indicated for Product A. I do not, however, think the reverse is true. Product B should take precautions such as using "geriatric" and/or "elderly" as negative keywords if Product B wants to include Product A as a keyword.

Scenario 3: Product A & B have overlapping, non-identical indications

In Scenario 3, both Product A & Product B might be able to use their competitor as a keyword, but the questions I would want to consider would be things such as how much overlap is there between the two indications, is it possible to distinguish people searching for Product A who ARE indicated for Product B from people searching for Product A who are NOT indicated for Product B. In some cases, such as when products have multiple indications, these questions might be very easily answered. In other cases, it might not be nearly as easy to target the appropriate population.

In all of these cases, my concern is not with the content of the ads themselves. Instead, my concern is that intentionally targeting a population that is not indicated for using my product on label could be evidence of an intent to market the product off-label. So, before engaging in such competitor targeting, I would want to be certain that I could justify my targeting practices as indeed being limited to the currently approved population.

Developing Compliant Search Engine Marketing

The week of Google text ads is here, at least for me and readers of this blog.

Last week, I spoke at a CBI social media summit about this topic, and on Monday, my article about the same topic was published by RAPS in its September issue of Regulatory Focus. By the way, this issue was guest edited by John Driscoll, and RAPS members can read more exclusive content at the RAPS website.

As always, I'm posting the article to my Scribd.com page and the presentation to my SlideShare page (links always available in the right rail).

But wait there's more!

All week, I'll be posting on some of the topics that didn't make the final cut for either the article or the presentation because it is definitely worth examining what I regard as the most important promotional tactic in the contemporary marketer's mix.

By the way, my distribution list received an email about this yesterday. To make sure you don't miss any new developments, just complete the contact form (also in the right rail).

I also offer discounts to speaking engagements and training sessions exclusively to people on my distribution list, and I promise not to spam you. So, hey, sign up for the list.

Finally, keep in mind that I'm available for a training session to help your company understand how to make use of this incredibly important technique and to design policies and procedures to ensure all of your promotional communications are compliant. Just fill out the contact form in the right rail and request a free initial consultation.

Google Text Ads Revisited

I just submitted a draft of my article about Google text ads for the September issue of RAPS Regulatory Focus. I was surprised at how much has changed since my initial piece on this topic about two years ago.

If RAPS agrees, I'll make a copy available on my Scribd.com page (which is always accessible via the link in the right rail of the blog).

I'll also be drawing upon much of that material for a presentation I'm delivering on September 12 at the CBI Social Media Summit in Philadelphia. I hope you'll join us.

Save Money While Learning about Google Text Ads

As I mentioned previously, I'll be speaking at CBI's one-day event on social media. CBI has confirmed that I can offer a $300 discount to anyone who contacts me via this blog.

Just fill out the contact form on the right, and I'll send you the promotional code by email.

Let's talk about paid search!

For many people, Google serves as the home page of the Internet, so it seems fitting that Google paid search ads and FDA's 2009 enforcement activity started the five-year path to the social media guidances FDA released this year.

I'm currently drafting an article about this topic for the September issue of RAPS Regulatory Focus, which is dedicated to the topic of advertising and promotional regulation, and I just accepted an invitation to speak about the same topic at a conference in Philadelphia on Friday, September 12.

CBI is holding the one-day event, and the agenda is packed with experts and friends, including both industry and consultants. It's certain to be a great event, and I hope you'll join us.

Still feeling the need to chat?

The highly anticipated FDA social media webinar happened today. Apparently, some people were able to attend; though based on my Twitter feed, it seemed as if more people were having problems than actually getting in.

I was one of those who experienced difficulties. I logged in at 1:45 for the 2 p.m. start because FDA had warned that it was already booked to max capacity. I received a message that the webinar hadn't begun and would start at 2 p.m.

2 p.m. came and no webinar, then 2:05. Then, I started scrambling trying to log in in a different browser, reloading the page, even restarted my computer.

Then (of course), I started checking Twitter and saw that other people were experiencing the same problems.

I received an email from FDA with a new link that also didn't work.

@US_FDA Tweeted out a message acknowledging the problems and promising to post slides later. BTW, they're here.

From what I can tell based on the commentary on Twitter, there was very little new ground covered. The consensus of the Twitter discussion was that FDA largely read directly from the guidances themselves (the slides seem to back up that view) and only chose questions to answer that were already answered in the guidance themselves.

As for the guidances themselves, I would suggest that there are still many unanswered questions, including this and this.

For an overview of the guidances, I'd recommend this one.

And given all of the technical difficulties and limited Q&A, I'm renewing my call for a Twitter chat about the guidances. If CDRH can do it, I'm not sure why the rest of the agency can't.