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.

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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.

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 identiļ¬es 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.

Avoiding Cherry Picking

I spoke at CBI's Social Media summit on Friday. It was a good session with lively discussion.

Among the questions that came up was addressing the FDA guidance on correcting misinformation. Attendees were interested in how to avoid the accusation of cherry picking what is correcting.

I emphasized in my response the need to have policies, procedures and documentation to handle this effectively. Specifically, your procedures for correcting misinformation should require (among other things) that the people who are responsible for correcting misinformation must clearly indicate prior to the review being conducted, exactly what they will be reviewing. They might specify a blog post, or a series of comments, or all blog posts between certain dates, etc.

Then, the people should identify ALL misinformation identified within that pre-specified area.

Separately, there needs to be a standard evaluated for determining what level and types of misinformation will be corrected. For example, only correcting misinformation about currently approved indications or correcting all misinformation regarding the product safety and risks but nothing regarding its efficacy.

Finally, the procedure for correcting the misinformation has to be spelled out.

Falling all of these procedures, and applying those procedures and standards to everything that is found without regard for whether the information being corrected is positive or negative about the product should protect companies from the accusation of cherry picking.

Why URL Shorteners Matter

Tom commented on a previous post about inVentiv Health's new URL shortener that all of this discussion is moot because we're all being forced to adopt Twitter's shortener anyway, and Marco followed up with some additional clarifications.

Both cite Twitter's support pages about this topic here and here.

So, there's an important correction to the previous post, and there's also a question about why I obsess on character counts and shorteners in general.

First, the correction.

I thought Twitter's 22-character limit on a URL was a maximum, not a minimum. It turns out it's both. No matter how short (or long) a URL is, when it is included in a Tweet, Twitter allocates 22 characters for the link and uses its t.co shortener service to send the user on his/her way to the destination URL.

Importantly, that limitation is different from what displays. A message that is too long will not necessarily display in its entirety, but the URL will count toward only 22 characters of your 140 character total.

Consequently, no URL shortener can offer character savings, and my claim that inVentiv Health was offering a real (though small) savings in the character count was wrong.

However, URL shorteners still matter.

To understand why, you have to first recognize that URL shorteners are just a special case of using URL redirects. URL redirects are simply ways having a user end up a different URL destination than what they click on (or enter into their browser's address bar).

There are many reasons why people make use of redirects. First, websites are constantly evolving and changing. When such changes happen, there's a need to send people using old URLs someplace, and redirects are an option instead of setting up error pages or making people find their way manually to their destination.

Second, some destination URLs are unwieldy. People can find long URLs difficult to read, comprehend, and type. By contrast, a redirect can be much shorter and easier to use.

Third, (and this one matters most to pharmaceutical marketers) there need not be any connection between the information or words provided in the redirecting URL and the eventual destination URL. That matters to pharmaceutical marketers because going back many years, FDA has made clear that usage of a product name in a URL counts as a mention of the product name. And that matters to pharmaceutical marketers because use of a brand name automatically brings with it certain requirements, such as the inclusion of the generic name, whereas a URL redirect enables you to avoid that product mention.

URL shorteners are just one special case of these redirects that provide the benefits of being easier to type. Because URL shorteners work by having an extremely brief root URL while appending a random string of characters to the end, they are not typically easier to read or comprehend.

There has been only one enforcement action from FDA's OPDP for the use of a URL redirect that I am aware of.

FDA made clear that the issue with the ad subject to the enforcement was that the other parts of the ad so clearly identified the product that the mere omission of the product name was not itself sufficient to claim that the ad was not a product promotion. So, one issue when using a redirect (whether shortening or not) is that you cannot simply assume that because the brand name has been removed from the URL that you have thereby prevented your ad from being a product promotion.

If, for example, your company makes only one product in a specific therapeutic category and is well known for doing so, then putting together a message that mentions your company name and the category is likely to be problematic.

Bringing all of this back to inVentiv Health's new shortener, using such a service will not save you characters on Twitter (though of course each platform is unique, and it might offer such a savings on other platforms).

It does, however, provide the advantage of avoiding the mention of a product in the URL that a user sees while still clearly communicating to the user that he or she is going to a webpage for a prescription product that communicates risk information. And these benefits will, to my mind, be more significant if the service becomes standard throughout the industry instead of each company developing their own shortener.

New Link Shortener for Risk Info

Update: Comments on this post pointed out an error. A new blog post explains that error and provides further information on the use of URL shorteners. http://regulatoryrx.blogspot.com/2014/09/why-url-shorteners-matter.html

inVentiv Health has a new link shortener that appears to make a very valuable contribution to the use of Twitter by pharmaceutical companies.

As I've talked about extensively (e.g., here, here, and here), there are difficulties with trying to follow the FDA social media guidance on the presentation of risk information in space-constrained contexts because of how much stuff FDA wants included in any single message.

Specifically, FDA says messages must include:
1. Brand name
2. Generic name
3. Non-misleading indication statement
4. Abbreviated risk statement
5. Link to complete risk information

In FDA's own example, just including all of the required elements takes up 134 of the 140 characters available for a single message.
NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk (page 14)
And FDA explicitly discourages the use of URL shorteners out of concern that the shorteners will obscure the nature of the information being linked to.
The Agency does not intend to object to the use of such URL shortening services; however, when possible, the Agency recommends that the URL or web address itself denote to the user that the landing page consists of risk information (e.g., www.product.com/risk). (page 10)
That puts sponsors in a bind because using the FDA's example, there were only six characters for the actual message itself after meeting the regulatory requirements.

inVentiv's solution is quite clever. It provides the benefits of a URL shortener while addressing the objection from FDA that such shorteners tend to obscure the information in the destination.

The shortener from inVentiv appends to a root of "RxRi.sk/" a short character string to a specific page dedicated to risk information. By including both the standard abbreviation of Rx for a prescription drug and taking advantage of the top-level domain for Slovakia (.sk), combined with the two characters Ri, the shortener clearly communicates that the destination location will include risk information about a prescription product without using nearly as many characters as the FDA's example.

In a few tests, the shortened string appears to have a consistent 13 characters vs. the 20 characters in FDA's product name. Of course, the FDA's example included the unnecessary characters "www." at the beginning of the URL, so even FDA's example is really only 16 characters in length.

Is a three-character saving really that big a deal?

Yes, I think it is, and I think there are a few reasons for that. First, every character matters when we're dealing with Twitter. Shaving a few characters here and a few there will add up and make for a far more flexible framework.

Second, inVentiv is making this shortener available to everyone free of charge. Consequently, this can become an industry standard if people are willing to adopt it, and having consistency in such communication platforms will make it far easier for people, especially consumers who don't spend all day thinking about how the FDA regulates prescription drugs, but who just know that Tweets from the medicine they're taking include scary information. For them, gaining familiarity that drugs have risks, and here is where they can find the risks associated with their particular medicine is valuable.

Third, the three-character improvement is for FDA's fictional product name of "NoFocus." FDA's actual recommendation is to always include both the product name and the word "risk" in the URL that directs users to the full risk information. "NoFocus" has seven characters. That seems to be the norm for top brands, as a quick scan of the top 10 selling drugs in the past year reveals three names with six characters, three with seven, and two with eight characters. There are, however, some drugs with much longer names, and if you're marketing a product with 10 or 11 characters in the name (of an extended release version with an "XR" added to the URL) the savings can add up.

Having a standard means of providing this information takes one item off the table when drug names are being created and evaluated.

Of course, some of these benefits are only realized if in fact people adopt inVentiv's shortener and make it a standard. We'll see whether that happens or whether some additional competing services emerge. At the very least, inVentiv has moved the conversation one step forward.

Get on the list!

September is always a busy month. I'll be publishing two articles and speaking at three conferences. As materials come available, I'll post them to my Scribd.com or SlideShare pages.

The links to these pages are in the right rail, and you can bookmark them.

I also maintain a distribution list of people who would like to receive updates from me. If you want to save yourself some time, then just complete the Contact Form on the right, and I'll add you to my distribution list. As new materials become available, or as important news warrants, I will send out updates directly to your inbox.

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And, of course, if you happen to need any of these services, please mention that on your Contact Form, and I'll set up time for your free initial consultation.