Recap of FDLI #AdPromo2023

Disclosure: I sit on the Planning Committee for the FDLI Ad-Promo conference. This is an unpaid, volunteer position. The contents of this post were not discussed with or influenced by any member of the FDLI staff.

This post provides some of the highlights from FDLI's ad-promo conference. An on-demand version of the conference presentations is available at: https://www.fdli.org/2023/11/advertising-promotion-for-medical-products-conference-on-demand/

The Food and Drug Law Institute's (FDLI) Advertising & Promotion for Medical Products conference wrapped up last week. I attended the conference and also moderated a panel on data privacy and concerns about the use of health data for the targeting of advertising.

The first day kicked off with a fireside chat with Arun Rao from the Department of Justice (DOJ), Lauren Roth from the Food & Drug Administration (FDA), and Serena Viswanathan from the Federal Trade Commission (FTC), led by Christine Simmon of FDLI.

FDA and FTC both noted their recent guidance updates. For FDA, that means the new Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers Guidance for Industry (SIUU) and the newly finalized Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements. 

FTC has also been busy, providing updated guidance on endorsements, reviews and testimonials, and a distinct Health Products Compliance Guidance.

DOJ, FDA, and FTC also mentioned the extent to which they are still very much digging out from the backlog created by the pandemic. More than three years after COVID-19 first came to our shores, its effects are very much still being felt.

Rao also mentioned a new policy from DOJ to create a safe harbor for self-reported disclosures made in connection with a merger or acquisition. Under this new policy, companies that learn of wrongdoing at a company they have acquired can be protected from later liability if they report the wrongdoing to DOJ within six months of closing the merger or acquisition. This is as Rao described it a "very big juicy carrot" to encourage self-reporting of wrongdoing, and it also ramps up the need for effective due diligence during the M&A to ensure that all wrongdoing is uncovered and can be reported.

One final point mentioned by Roth is the importance to FDA of combatting misinformation about medical products. Commissioner Califf has repeatedly warned about the need to combat misinformation, and it is not a stretch to see FDA's SIUU guidance as one small step in that direction. By providing further guidance about exactly how sponsors can share truthful, not misleading information about unapproved uses, FDA is enabling efforts to get good information from the people who should be seen as the most reliable source of that information, the product's sponsors.

The next session of the day included an update from OPDP, APLB, CDRH, and CVM related to advertising and promotion.

Katie Gray from OPDP gave a detailed presentation on the Recorlev enforcement action from earlier this year and an overview of the SIUU guidance. Lisa Stockbridge from APLB provided a reminder on reminder advertising, indicating that this well-established category of communication continues to cause firms difficulties. Debra Wolf of CDRH emphasized that although there has not been a significant amount of publicly available enforcement actions from CDRH, the Agency continues to have many private communications with firms about their marketing efforts.

The next plenary session covered scientific exchange and pre-approval communications. Elisabethann Wright of Cooley provided particular insight into the EU's approach, which of course varies widely by country, and has been especially active on platforms such as LinkedIn. Of note is the extremely active role played by the industry's own associations in not merely promulgating guidance and establishing codes of conduct but in regularly enforcing violations of those codes against member companies.

After lunch, the first set of breakout sessions occurred including the panel I moderated on data privacy. I found the discussion very lively and enjoyed hearing from Elisa Jillson from the FTC, Lyra Correa from HHS's Office of Civil Rights, and Nancy Perkins from Arnold & Porter. I have previously opined that the 2020s will be most known for its focus on privacy, and while the cookie-less future we keep hearing about gets pushed back once again, there's growing awareness and concern about how much deeply personal information has been given up and on how companies are using (or misusing) that data.

Simultaneous sessions looked at the recently finalized guidance from the FDA on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements while another session looked more into the promotion of veterinary products. Because I was leading another session, I couldn't attend either, but I'm looking forward to using that link provided earlier to view the recordings. 

The afternoon plenary sessions resumed with a look at FTC's role in enforcement of healthcare advertising and closed out with a session on that perennial chestnut of social media usage.

Day two of the conference kicked off with an enlightening discussion of so-called CFL (Consistent with FDA-Labeling) claims. Torrey Cope of Sidley Austin provided an insightful look not just at FDA's enforcement post-guidance for claims that failed to meet the CFL standard, but also for taking the time to examine the nature and wording around the acceptance by FDA of so-called Real-World Evidence (RWE) in the context of product approvals. RWE is not the sole source of CFL claims, but Cope was able to provide some valuable lessons.

The afternoon's breakout sessions included one on artificial intelligence (which I attended), promotional challenges in rare disease treatments, and navigating accelerated approval promotion.

The closing session focused on other avenues for enforcement, including of course, the Better Business Bureau National Advertising Division's (NAD), as well as general counsel to general counsel complaint letters, filing complaints with the FDA, and perhaps even bringing a Lanham Act case.

The NAD's finding against Novartis earlier this year was of course a hot topic. But it is worth noting that in a more recent case, Viiv simply declined to participate in the NAD process. NAD referred the matter to FDA and FTC noting that decision, but as of the writing of this post, no further action by the government has been seen.

Alan Minsk of Arnall Golden Gregory noted the importance of determining your goal when looking at the appropriate path. If your goal is get a competitor in trouble then you really need to rely on the government or the courts, but if your goal is primarily to just get the company to stop the use of misleading promotion, then NAD or a direct complaint letter might be a far more cost-effective solution.

Overall, the conference was a huge success, though my opinion should be viewed as biased because I sit on the conference planning committee. FDA is definitely digging itself out from the pandemic backlog. I fully expect we'll see more from the Agency, as a very active 2023 has already demonstrated.

One-click Legislation Lives On

On Friday, the House of Representatives passed the 21st Century Cures Act. An early draft of this legislation included a provision about social media that would have essentially written the one click rule into law.

This video presents the exchange between Dr. Janet Woodcock, who leads the Center for Drug Evaluation and Research at FDA, and Representative Billy Long of Missouri about that provision (exchange begins at 2:35:35 mark).

Unfortunately, that provision didn't make it into the final version that passed last week; however, one click isn't finished just yet. As I discussed in a new column for DTC Perspectives and another recent article in The Medicine Maker, this is far from finished.

Representative Billy Long of Missouri has sponsored this item as a standalone piece of legislation. In addition, copy and paste is one of the easiest technologies to master, and once draft language is available, there is a tendency for it to get picked up in other efforts that aren't always directly related.

It's worth noting in that regard that discussions have kicked off in earnest about the renewal of the Prescription Drug User Fee Act (PDUFA). The last time this legislation came up for renewal was 2012, and that renewal included a mandate that FDA release guidance about using social media, leading directly to a new national holiday.

At the moment, one click doesn't have a Democratic cosponsor, but I know from conversations with Rep. Long's office that they consider this a bipartisan issue and expect to find a Democrat to sign on. Certainly, from my perspective, there is nothing partisan about this topic. People are adopting social media channels, and there is an incentive for industry to provide truthful, balanced, FDA-regulated information to them. But FDA's current interpretation of the regulations makes it difficult (and frequently impossible) for industry to provide that information.

It is worth pausing to consider the implications of industry's forced absence from these conversations. Of all of the information that is available about prescription treatments, the ONLY information over which the FDA has jurisdiction is promotional communication by industry. So, the only people who are required by the FDA to provide accurate, balanced information are currently being hindered in their efforts to provide that FDA-regulated information.

And as Aristotle (and Gary Larson) taught us, nature abhors a vacuum. Absent industry's involvement in these platforms, others, who don't face the same restrictions, will participate. Some of that information will be accurate; some of it won't. None if it will be subjected to the same high standards required by the FDA for industry's communications.

How Not to Submit Interactive Materials to FDA

In two recent guidances, FDA has requested that sponsors submit materials "in an archivable format that allows FDA to view and interact with the submission in the same way as the end user (e.g., working links)."*

I understand the need to experience digital promotional communications in their native environment to fully appreciate the communication and ensure its compliance.** However, achieving the stated goal of creating an experience for the FDA reviewer in the submission that is the same as the end user is not practical.

The most common format for submitting materials to FDA for the postmarketing submission of promotional materials is via the .PDF document format. Websites, emails, and other digital tactics are converted into PDFs. Typically, this process is achieved by taking screen shots of each webpage or other unit, gathering those screens into a convertible format such as .jpeg files and combining those files into a single .PDF file.

There are various techniques for doing this, and lots of software out there to assist with both the screenshots and the conversions. Adobe has at various points provided software additions that purported to convert an entire website into a single .PDF file at the click of a button. I've worked with most if not all of these solutions, and none of them work. At the end of the day, the only reliable technique to create a .PDF file that looks like the finished piece is to do so manually.

To convert such a file into a piece that functions in the same way as the original thus requires manually building into the .PDF file individual links that move the user around the PDF in the same way as the hyperlinks behave in the website (or email, etc.).

Depending on the complexity of the original piece, that task can be considerable. For example, a 12-page website probably actually has about 25 pages once error states, index pages, and other miscellaneous aspects are included. Assuming 10 hyperlinks per page (which is low), that's more than 120 individual hyperlinks that have to be created (and checked) prior to submission. It's very easy to introduce an error during that manual build.

And the resulting PDF will never be used other than for a 2253 filing. So, there's a lot of effort to create something that no one (outside FDA and the sponsor company) will ever see. A lot of effort with a high likelihood of error for no benefit.

As if this were not reason enough to avoid creating this file, the timing for its creation could not be worse. Digital tactics aren't like print ads. When I submit a print ad to the FDA for a postmarketing submission, the actual ad itself is unlikely to be on newsstands for several days or even weeks. But a digital tactic will often go live immediately after the materials are submitted to the FDA. Every additional minute spent creating the file for the postmarketing submission is a delay in making the materials available.

This also ramps up the pressure on the ad agency or other responsible party to complete the submission as rapidly as possible. That pressure further increases the likelihood of an error being introduced.

To recap, creating fully functional PDFs that recreate the end user experience of a digital tactic is an expensive, time-consuming, error-laden process that delays the deployment of promotional communications and benefits no one other than the FDA reviewers. This is one time I think industry is likely to ignore FDA's request.

* Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, page 6, note 7. See also "The website should allow the FDA reviewer to click on links within the website," in Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs, page 31.

** Indeed, a significant portion of my primer on this topic is devoted to the idea that reviewers have to understand and experience the platform to determine its compliance.

Using Periscope for Regulatory Updates

Twitter released a new app a few weeks ago called Periscope. Periscope enables users to broadcast live from their mobile devices. Depending on how the broadcast is shared, you can either make the broadcast available to everyone or only a select few people.

I've been playing around with Periscope to get a feel for how people are using it and also to see what if any interesting regulatory issues it raises.

It's possible to create a distinct identity on Periscope from your Twitter identity; however, I'm using Periscope as @PhillyCooke.

One way I've seen Periscope be adopted by the larger non-pharma community is to provide additional "behind the scenes" footage from television performers, specifically people who host interview programs. I've also seen it used successfully for Q&A sessions because viewers can type responses, feedback, and questions into the app, and those comments are then seen by everyone viewing the broadcast including the presenter.

Next week, I'll be broadcasting the Philadelphia RAPS chapter meeting. We're having Jay Crowley speak about UDI.

Jay spent more than 25 years at FDA and is widely regarded as the godfather of the Unique Device Identification system, so we're extremely excited to have him speak. Another chapter chair asked whether we could turn the event into a webinar or otherwise make Jay's talk available to a wider audience, and that's when I decided to leverage Periscope.

So, start following @PhillyCooke on Periscope, and tune in next Thursday, May 7, at 6:30 to listen in to Jay's talk.

Five Things to Notice About FDA's Electronic 2253 Filing Guidance

Today, FDA produced its long-awaited guidance of submitting promotional materials electronically.

As ad-promo guidances go, this is a hefty one, weighing in at nearly 40 pages. For comparison, last year's two social guidances released on social media guidance day totaled 30 pages combined.

Rather than trying to provide a comprehensive digest of the guidance, I'm going to here provide a framework for understanding the guidance and point out some the items that leapt out at me on a first reading.

1. What is this guidance about?

Up till now, FDA's two primary groups responsible for overseeing the promotion of prescription drugs and biologics, the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER) have had different policies about accepting electronic filing of promotional materials. APLB accepted them; OPDP didn't.

Moving forward, both agencies will accept promotional material submissions electronically, and they will do so using the common eCTD format used for all other electronic submissions, such as NDAs and BLAs.

2. Which submissions are affected?

This guidance affects only submissions of promotional materials to the FDA, and such submissions are either voluntary or mandatory. All promotional materials for any prescription drug must be filed with FDA at the time of initial dissemination or publication (though see here for an important exception regarding social media). In addition, a small class of products (call subpart H or E) have additional mandatory submissions.

In addition, companies sometimes request voluntarily that FDA provide feedback (so-called advisory comments) on draft promotional materials. Companies do so to minimize the likelihood of receiving an FDA enforcement action, since the worst situation a company can find itself in is having spent money to develop promotional materials only to have FDA take enforcement activity that requires the company pull the existing materials and lose the time and money of creating all new materials. Voluntary submissions of promotional materials primarily include requests for advisory comments from the FDA on a newly approved product in its launch phase, TV spots, new messaging, or perhaps as a result of previous enforcement activity.

Because all submissions of final samples of promotional materials include a completed copy of Form 2253, these submissions are typically referred to as 2253 submissions. Though note that APLB requires that companies include Form 2253 for voluntary submissions of draft materials for advisory comments; and that difference will continue even in the new eCTD submissions as proposed in this guidance.

3. Guidances are usually voluntary; but this one isn't (sort of)

Right now, everything in this guidance is voluntary; and the guidance itself is in draft status. There is no requirement that any company begin adopting the procedures set out in this guidance today.

HOWEVER, after this guidance is finalized by the FDA, then parts of the guidance (the parts addressing mandatory submissions of promotional materials) will become mandatory 24 months later.

So, even after the final guidance is released (and there's no way of knowing when that will be), only parts of this guidance will represent mandatory changes; but the mere fact that some parts of the guidance are mandatory is itself a significant difference from most other guidances.

4. But aren't TV spots required to be submitted for review 45 days prior to use?

No. PhRMA's guiding principles on DTC television advertising recommends that companies submit them to the FDA with sufficient time for FDA to review them, but this is not a regulatory requirement. It is only binding on PhRMA signatories, and even then, the companies are not required to submit the materials for advisory comment, just to give FDA time to comment, should the Agency choose to do so. 

Also, FDASIA granted FDA authority to mandate that TV spots be submitted to FDA 45 days prior to airing for FDA to comment, and FDA issued a draft guidance about how it would implement such a program. However, as this new guidance states repeatedly, that guidance has not yet been implemented, and FDA does not want companies to follow those procedures currently. The process itself is deeply problematic, as I pointed out in an appendix to my primer on the topic.

5. Is there any glaring change from current 2253 submission processes?

This guidance provides far more extensive discussion of the submission of promotional material than previous direction. Most of the discussion will sound familiar to ad-promo professionals. One item that leaps off the page in the section on final samples submission is this passage:

Firms are also encouraged to submit annotated versions of the promotional material(s) cross-referenced to the product labeling and references, if applicable. (page 6)

Standard final samples submissions do not include references, and this "encourage[ment]" appears in a section of the document that otherwise will cover mandatory changes. Adopting this change would be deeply problematic for most promotional materials.

In the standard review and approval process, the references are only included for the initial medical legal regulatory (MLR) review, and then deleted from subsequent check-changes, and final samples submissions to the pharmaceutical company. Adding references back for the final 2253 submission would create significant additional expense, and would create additional possibility for error during the most time-sensitive portion of an elaborate process. 

DTC Perspectives Article Out Now

Apologies for the lack of posting.

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

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

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

"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.

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.

Eliminating the Disparity in 2253 Filing Requirements

One of the difficulties with the guidance on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (or the 2253 guidance as I call it*) on social media is that it establishes a distinction in filing requirements between forums that are publicly accessible and those that are not.

Sponsors of prescription products who wish to engage in social media are granted two pathways via this guidance for meeting their 2253 filing requirements, which is the obligation to submit all promotional materials at the time of first use or prior to initial dissemination.

For forums that are publicly accessible, sponsors can submit the initial communication on a third-party site, along with any home or profile page, and the URL where the real-time communications will occur. Then, every month, firms should submit the list of all URLs where it is engaging in real-time communications.

However, forums that are not publicly accessible have a different requirement. Instead of merely submitting a list of URLs each month, FDA requests that sponsors who choose to use such forums submit screenshots of the interactions that occur.

It has been pointed out by others (including yours truly) that this distinction is difficult to understand or draw in practice. For example, many platforms have a minimal requirement that to view any discussions in the platform, you must be a member of (and logged in to your account on) the platform. Would such a requirement be seen by the FDA as making the site not publicly accessible?

Moreover, for third-party sites, this requirement might change without notice. Were that to happen, a sponsor could go from being in compliance to being out of compliance without having themselves made any changes, and that seems odd. It certainly seems that what a sponsor is operating compliantly should not depend on the policies of a third-party site.

Another difficulty is that the disparity in filing requirement is huge and would put a barrier in front of participating in non-restricted forums. Preparing all of the screenshots on a monthly basis could be a significant undertaking depending on the volume of the communications in the forum. While that might seem desirable at first blush, there are good reasons to want to operate such closed forum. Such forums enable, for example, full verification of credentials prior to admission. That means that information can be more freely shared without concern that people who should not have access to the information might receive it. For example, if I were the sponsor of a pain medication, I might want to discuss methods that some patients are using to circumvent abuse prevention mechanisms, but obviously I would not want that information to be available in a publicly accessible forum.

The essence behind this requirement seems to be the desire of FDA to monitor the real-time communications and to rely on the possibility of FDA monitoring of communications to ensure that all communications are appropriate.**

One way of addressing these concerns and eliminating the disparity in filing requirements is to require that when sponsors make use of third-party platforms with restricted access that they set up credentials for FDA to access the forum.

It would be easy for FDA to create an email address and name (e.g., OPDP Social Media & OPDPSocMed@FDA.gov) that could be created as a user for any restricted access platforms. To further simplify things, FDA could establish and publish a list of its credentials on the most prominent forums (e.g., YouTube, Facebook, LinkedIn, Twitter) for monitoring purposes. In that way, sponsors could simply create a user account with FDA's credentials when they set up their restricted-access forums. The sponsor could then include as part of their initial 2253 filing requirement a password (if required) for FDA to access the forum.

From that point forward, sponsors would then be on equal footing with the requirement simply to file monthly reports indicating their continued involvement in the platform but not being required to submit screenshots of all of the interactions.

This method would enable FDA to monitor the conversations in real-time without creating a disparity in filing or a barrier to establishing and maintaining restricted-access forums. It also would ensure that changes made by third-parties could not cause a sponsor to find themselves out of compliance with FDA requirements.


* It is worth noting that the guidance also affects filing of FDA Form 2301 for veterinary medicines. Nothing in this post is affected by this nuance.
** Quoting from the guidance, "if a site has restricted access and, as such, FDA may not have access to the site" (page 7, emphasis added)

Social Media Webinar

I'm presenting a webinar for LSTI on Wednesday, October 8.

In the webinar, I'll be taking a step back from the individual guidances we've received and try to give marketers and others interested in the use of social media for promoting prescription products the 50,000-foot view.

By doing so, I hope to provide a roadmap for people who are struggling to determine what they can expect from FDA and how to move forward on implementing social media initiatives.

Here's the link to the full description and registration information: http://www.lifesciencetraininginstitute.com/doc/fda-guidance-on-social-media-questions-answered-and-unanswered-0001

Hope you'll join!

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.

EyeOnFDA Webinar Available Now

I mentioned in a previous post that Mark Senak of FleishmanHillard conducted a webinar about the FDA's social media guidance, and I promised to post a link when he made the recording available.

Well, it's now available here.

FDA Social Media Guidance Webinar

I have been trying to get the FDA to host a Twitter chat, having suggested it on Twitter, and then followed up on this blog.

This morning @US_FDA announced that there will be a social media webinar later this week. There isn't much information about the webinar at the registration page, but the confirmation email includes the following description:

The purpose of this webinar is to provide an introduction and overview of FDA’s three recently issued social media draft guidances Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,  Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices and Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices. Subject-matter experts will also be available to answer questions regarding the draft guidances and provide further explanation of key concepts.

I hope you'll join the webinar as I'm sure we're all anxious to have this Q&A on the three social media guidances this year.

FDA Was Wrong About Google Functionality

I didn't say very much about the use of Google text ads in the Regulatory Alert that I released last week about the FDA space-limited risk & benefit presentation guidance. Partly, that's because I'm working on an article about Google text ads that updates the chapter in my primer.

There is, however, one extremely important item to point out. FDA got sitelinks wrong. I don't mean that I disagree about the FDA's view on the use of sitelinks. I mean they don't understand the technology, and what they say in the guidance demonstrates that.

The FDA guidance recommends using sitelinks to include some risk information that the FDA says people must include if they are presenting product benefit information (and the product name). The example they give is:

In this example, the benefit information "For severe headache from traumatic brain injury" requires corresponding risk information to be balanced.

The FDA accomplishes that risk presentation via the various sitelink descriptions "Potential for brain swelling," "Life-threatening drop in heart rate," etc. Importantly, the words in the sitelinks themselves "Boxed warning," "Warning," and "Risk information" do not themselves constitute risk information, just links to risk information. Consequently, those links in themselves do not suffice to provide the risk information.

The first problem with this is that FDA is assuming that a product manufacturer can guarantee that their ads have the sitelinks and the link descriptions appear when they run the ad. But you don't have that control.

Google does not guarantee that sitelinks will ever appear. In fact, Google's page dedicated to sitelinks in paid search campaigns, includes a section header called, "Why your sitelinks aren't showing," and the first sentence under that header reads, "Keep in mind that your ads won't always show sitelinks."

That's a problem because if your ad is running with benefit information presented in the body of the ad, the ad requires the risk information to meet the fair balance requirement. If your ad displaying the benefit information does not include the sitelinks, then the ad would violate the fair balance requirement.

So, if the maker of HeadHurtz were to actually run the ad that the FDA provides as an example, there's a significant chance that the ad would actually appear as follows:

This ad would definitely be violative because as we learned in 2009, and as FDA reiterates in this guidance, if the product name and benefit information is presented, then FDA requires that some risk information be presented at the same time with comparable prominence as the benefit information.

So following the FDA's provided example could result in violative promotional activity. Moreover, even if the sitelinks appear, there's a chance that the sitelink description would not appear. But again, the sitelinks provided in the example ("Warning," etc.) do not in themselves provide risk information. So, just providing the sitelinks would not meet the fair balance requirement.

Further compounding the problems with the FDA's example is that the order and number of sitelinks provided varies without complete control by the advertiser. So, if all four sitelinks were not provided, there's a chance (based on FDA's guidance) that the advertiser might not be complying the fair balance requirement because FDA might deem it necessary to provide ALL four sitelinks to meet that requirement.

As if these problems were not enough, there's one more difficulty: mobile devices. If this ad were enabled for display on mobile phones (which is not required for Google ads but is encouraged), then you would definitely not have all four sitelinks presented, and none of the descriptions of the sitelinks would be presented.

So, the sample ad presented by the FDA could definitely not run on mobile phones, but of course, mobile access to the Internet is exploding, and in fact, some people (hint: me) believe that providing information via mobile devices is even more important than doing so via desktop.

A Different Twitter Proposal

I've been thinking further about the FDA social media guidances delivered this week and especially the "Twitter" guidance, which isn't just about Twitter, but which does have significant implications for brand communications on Twitter.

What if the FDA had proposed a different framework?

Here's the FDA's sample compliant Tweet:

NoFocus (rememberine HCl) for mild to moderate memory loss-May cause seizures in patients with a seizure disorder www.nofocus.com/risk 

This Tweet takes up 134 of the 140 characters available on Twitter. It includes

• Brand name (NoFocus--7 characters)
• Established name (rememberine HCl--17 characters including space and parentheses)
• Link to risk that includes both brand name & indication that risks are presented (www.nofocus.com/risk--20 characters)
• A hyphen to separate benefit from risk info (1 character)

These are the mandatory elements of the Tweet, and they take up 43 characters with the balance available for communicating both the most serious risks and a non-misleading indication statement.*

Of course, the exact length of the brand and established names will change the number of characters that are set aside for accommodating the FDA's proposed mandatory elements. 

One challenge is that almost no brands will be able to provide a non-misleading indication statement and all of the most serious risks** in the space that's available after meeting FDA's mandatory elements. 

Another challenge is that although the FDA might not object to the sample Tweet they provided, users of Twitters certainly would object. Their objection wouldn't be to the regulatory compliance of the Tweet. Their objection would be to its value, as in, it has none. While such a Tweet might occasionally be useful for some products, and perhaps be a promoted Tweet on occasion, not many people would be inclined to follow an account peppered with this type of content.

The sample Tweet provided by the FDA is analogous to someone going on Twitter and saying, "I'm great. Read more about me here." And although some people do in fact use Twitter to do that, people who primarily send out such communications are rarely successful. Instead, communications need to meet the needs of the other users of Twitter, who might be looking for information about a product, news, etc. 

Responding to such information seeking behavior and providing customer service are two of the best uses of Twitter by companies (not just pharmaceutical companies), and it is not unreasonable to believe that most of these needs can be fulfilled without providing any benefit information about the product. So, if, for example, I want to know how to sign up for a co-pay program for your brand, just getting a reminder-style Tweet with a link to the co-pay program link can be very useful. Some companies are already engaging in this type of activity.

That's one reason that it was so disappointing that the guidance didn't address reminder ad formats.

However, on occasion, there might be a need to include benefit information, and when that happens, the format set forth in this guidance is greatly limiting and not likely to be accessible to most brands. So, instead, I was considering a format along the following lines:

The brand name would be presented in the Twitter handle, not the body of the Tweet itself. The Twitter handle has a 15-character limitation, and limited risk information could be presented in the Tweet in a manner that makes clear that additional risk info is available at the destination URL.

Modifying the FDA's Tweet to meet this proposal would yield this sample Tweet:

For mild to moderate memory loss-Risks incl seizures in some ppl bit.ly/isi

Assuming this Tweet was sent from @NoFocus, let's see how that Tweet compares to FDA's format.

Because both the brand name and the generic are omitted from the Tweet itself, that eliminates 25 characters from the Tweet that were taken up by those two elements plus the space between them. I expanded from the hyphen to include the phrase "Risks incl" so that's a growth from one character to 11, but I did that both to provide explanation for users about what the next few characters were going to present as well as to set up the expectation that the link that is provided will have further risk information. It is extremely common on Twitter to abbreviate the word "include" with "incl" so that is likely to be understood by most users of the platform.

Then, I made use of a URL shortener (bit.ly) and a common abbreviation for the page name (isi) where the risk information is provided. This meets the FDA's criterion for the URL that it not be promotional in content or tone, and because I preceded it with the phrase "Risks incl" users expect to find product risks presented at that page, which the FDA accomplished in its example by including the product name and word "risk" in the URL itself.

The phrase "Risks incl" also accomplishes the goal of clearly communicating within the Tweet itself that the brand is NOT providing all of the risks associated with the product within the Tweet itself. So, users are alerted that there are other risks to the product and they can learn more by clicking on the link. 

The revised Tweet is only 75 characters with 21 characters devoted to providing mandatory risk information, not including the risk statement itself which would vary by brand:

• The phrase "-Risks incl" (11 characters)
• A shorter url linking to the risk information (bit.ly/isi--10 characters)

And in that case, I would be able to provide additional links or other information such as directing this Tweet to another user. Imagine the following exchange:***

@phillycooke: My father was prescribed Brandufate by his doctor. What does Brandufate do?

@Brandufate: @phillycooke It's for mild to moderate memory loss-Risks incl seizures in some ppl bit.ly/isi

In the conversation, I have now presumably provided some value to the person who was looking for information about my product, while meeting almost all of the FDA's requirement.

I write "almost all" because I didn't include the generic/established name in this example. My belief is that in this type of space-limited context, it would be better for the FDA to permit that the established name be provided via the landing page with the risk information, not in the Tweet itself. I believe that meets the needs of users better and also provides extremely valuable characters for communication in the Tweets themselves.

The FDA's guidance explicitly points out that it is not addressing the landing pages, home pages for brands on Twitter, etc.. It is worth noting, though, that a brand's participation on Twitter is not limited to the Tweets it sends, but also includes the brand's home page, description, and a Twitter icon. These other locations provide what I believe are more appropriate locations for presenting the full brand and generic names in compliance with all of the FDA requirements for presenting the established name.

And because Twitter has a verification service available, it would be possible for users to understand via the blue checkmark icon that the account providing them information is an official representation of the brand, who is subjected to FDA regulatory oversight and therefore meets a higher standard for accuracy.

I'd love to get some additional feedback on this proposal, so post your comments, send me your emails, and let me know.

* Keep in mind that the FDA is saying that both of these elements are required. It is not OK to omit either the risk or the indication statement.

** And the guidance is unambiguous about the need to include ALL of the most serious risks. Quoting from the guidance: 

At a minimum, a firm should communicate the most serious risks associated with the product together with the benefit information within the individual character-space-limited communication. For a prescription human drug, the most serious risks would generally include all risk concepts from a boxed warning, all risks that are known to be fatal or life-threatening, and all contraindications from the approved product labeling (the PI). (p. 9)

*** For my modified Tweet, I'm changing the brand name because @NoFocus actually exists on Twitter as a user. I created an account for @Brandufate for demonstration purposes. 

DH LifeBrands Regulatory Alert Available Now

The Digitas Health LifeBrands Regulatory Alert about the two social media guidance documents from the FDA is now available.

You can read it here on my Scribd.com page. As a reminder, everything I publish is accessible via that page, with the convenient link on the right of the blog.

Would love to hear any feedback about this in the comments, including the correction of any misinformation on this third-party website, should the FDA choose to apply its guidance.

Let's have a chat!

Some of you might recall that in the fall, CDRH released a finalized version of its mobile apps guidance (see here and here on that). A few days later, they hosted a live Twitter chat on the topic. They used the hashtag #FDAapps and have actually kept that going for ongoing updates.

I participated, as did I'm sure many of you, and it extremely informative. I commend CDRH for setting the precedent and embracing new platforms for outreach.

In that same spirit, I suggest that now is the perfect time for OPDP, APLB, and CVM's advertising arm to join Twitter (none has an official Twitter presence so far as I'm aware and based on the FDA's official listing of social media accounts) and talk about the new social media guidance on presenting benefit and risk information in space-limited contexts. This seems especially appropriate given that the guidance dwells so heavily on Twitter usage.

I floated the suggestion on Twitter yesterday, and @FDAmedia picked up on it. So, now, I'm hoping you'll help me keep the conversation going by Tweeting, posting, sharing, etc., to see whether we can get FDA to participate.

And even if we can't get FDA's involvement, let's plan on holding a Twitter chat of our own on this topic soon.