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.

What Kim Kardashian Could Have Done

Update: Apparently some people are weighing in on this issue who don't follow FDA ad-promo issues. For their benefit, I'm including a link to my post about why a link to the risk information doesn't suffice, i.e., why one-click isn't a rule.

Today, FDA's Office of Prescription Drug Promotion posted a letter citing Duchesnay for violative promotion relating to social media posts made by Kim Kardashian. The violative materials clearly included a discussion of the product's indication combined with the use of the product name, and a picture of Ms. Kardashian holding the product's bottle with the name prominently displayed.

Instagram Post from Violative Materials on FDA Website

It should come as no surprise that FDA objected to this presentation. In its letter, FDA cited both an omission of material fact and the omission of risk information.

And though I risk being accused of doing this solely for the clickbait, I'd like nonetheless to spend a bit of time looking at the violations, and the promotional material because there were options to engage in this promotional activity while complying with FDA's regulations and guidances.

First, look at the image above. Clearly, the image itself included the product name, and the submission to the FDA included a note stating that "image of Diclegis bottle will be prominent enough to read established name." This image (if used alone) would probably have been OK as a straight reminder promotion, which is only required to include the brand and generic names. It is, admittedly a bit difficult to tell from the material posted by the FDA whether the note on the material is indeed accurate, i.e., whether the generic (established) name would indeed have been legible, but it certainly is within the realm of possibility that both the brand and generic name would have been legible, and thus that the image alone might have been acceptable promotional material.

And if the image had been used alone (and the generic was actually legible), then it would have been compliant, so that was Duchesnay's first option. Engage in Reminder Promotion. Just show Ms. Kardashian holding the product bottle.

Option 2 would have included additional copy but still remained within the reminder ad format. You could easily imagine copy along the lines of: "I use Diclegis. You should ask your doctor about it." Such copy would not inherently have provided any indication or representation of the product's usage, and thus would appear to be acceptable within the reminder ad format.*

However, the accompanying text did not limit itself to the reminder ad format. Instead, that copy clearly alluded to the product's indication with Ms. Kardashian's message discussing her morning sickness and making a claim about the product's efficacy and its safety.

Of course, another option for Duchesnay (and Ms. Kardashian) would have been to omit the product mention and simply redirect followers to a location where the full product promotion could have been delivered. Such a communication could have teased the product, "Guess what helped me alleviate morning sickness" so long as it didn't refer to, or imply, the specific product.

That would have been tricky to do since Diclegis is currently the only FDA-approved treatment for morning sickness, but I think it would have been possible to do so, especially in a product category where there are tons of home remedies, homeopathic, and other OTC drugs that are used (sometimes off-label) for morning sickness.

So, this is Option 3: A redirecting ad that omitted product mention (or picture) but that took people to a location where the full product promotion could have been supplied.

Would it have been possible for Duchesnay to take advantage of the space-constrained product guidance released by the FDA on National Social Media Guidance Day?

The first thing to notice here is that although I've only posted and discussed one post from Ms. Kardashian, there are at least three that were involved in the violative materials. In addition to the Instagram post shown above, there was a Tweet and a Facebook post:

Tweet from Violative Materials on FDA Website

Facebook Post from Violative Materials Posted on FDA Website

Instagram does appear to have a character limitation to its posts. The limit is 2,200 characters. Diclegis.com has an ISI posted with more than 3,000 characters, so it would have taken some editing to fit the complete ISI into the post, but it's not entirely clear that the editing would have reduced the total information provided. Hence, it's unclear whether there would have been any need to take advantage of the space-limited guidance to accommodate a compliant message in this particular forum.

Of course, the third post is a Tweet, and the Tweet makes use of precisely the redirecting ad format discussed above in Option 3. However, instead of redirecting users to a page with all of the elements required to meet the product promotion requirements, the Tweet directed users to the Instagram post, which the FDA found to be violative.

I've previously commented on how difficult it is to fit all of the required elements into a Tweet, and it's an open question whether Duchesnay could have done so.

Let's try.**
Required elements are:

1. Brand name
   Diclegis--8 characters
2. Generic name
   doxylamine succinate and pyridoxine hydrochloride--49 characters
   But taking advantage of FDA's willingness to accept abbreviations, we can shorten that to doxylamine succinate & pyridoxine HCl--37 characters
3. Non-misleading indication statement
   It's unclear exactly what FDA would have considered an acceptable statement of the indication. We know from the letter that FDA considered the omission of the limitation that the product has not been studied in those with severe vomiting (hyperemesis gravidarum) an omission of material fact, so presumably that would have been needed in the Tweet. Let's try
   For morning sickness, but not w severe vomiting--47 characters
4. Contraindications (other than mere hypersensitivity to the active ingredients)
   In the case of Diclegis, this means those using MAOIs
   Don't use w MAOIs--17 characters
5. Abbreviated risk statement*
   Risks incl severe drowsiness--28 characters
6. Link to full risk info
   Diclegis.com/risk--22 characters***

Putting it all together, you'd have

Diclegis(doxylamine succinate & pyridoxine HCl) For morning sickness, but not w severe vomiting Don't use w MAOIs-Risks incl severe drowsiness Diclegis.com/risk

That's a total of 165 characters, and I'm taking some liberties by using abbreviations FDA has not formally endorsed, and perhaps underestimating the characters FDA might require to communicate some of the elements.

Now, though, consider the context. Imagine for a moment that the character count were 139 instead of 165. Could anyone imagine Ms. Kardashian sending out that Tweet?

I can't either.

So, this takes us back to the options above:

• Option 1: Picture Reminder Ad (Product pic with generic name prominent and legible)
• Option 2: Reminder Ad with Additional Copy
• Option 3: Redirecting Ad

Absent any changes, that's where prescription product promotion in social media stands, and we'll need to do some work to keep up with...(just can't finish that sentence).

* I'm assuming that the bottle would have been a more prominent presentation of the generic name than the copy, but the specific execution of this option might have required inclusion of the generic in the copy as well.
** Note that in the following, I am taking advantage of several abbreviations that have not been explicitly endorsed by FDA (such as the use of "w" for the word "with" and "incl" for the word "include"). These abbreviations are extremely common on Twitter, but they do go beyond FDA's explicit endorsement of the "&" for the word "and."
*** For more on why this is 22 characters long, see my earlier post on counting characters.

"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.