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)
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 ChangesThere 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 1They can simply display the company name as the display URL.
|Sample ad showing company name as URL|
Option 2They 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.
ConclusionAs 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.