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.

"New" Mobile Apps Guidance Released

I'm using the word "new" in the headline of this blog post in the technical sense that FDA uses for promoting drugs, namely within the past six months, because the new guidance was actually published in February of this year. I didn't notice it at the time, so apologies for the late notice.

I'm blogging about it anyway because the topic is of interest in general (namely what apps are subject to FDA enforcement focus vs. enforcement discretion), and because the update itself is interesting to FDA process geeks like me.

Here's a quick timeline for the uninitiated:

In 2011, FDA released its first draft guidance* about how it would apply its regulatory authority to the realm of mobile apps. Here's my take at the time.

Industry (and Congress) reacted as if FDA were suddenly imposing a new set of regulations on a vibrant and rapidly evolving technology, despite the fact that FDA had been regulating apps for years.** As a result, there was significant pressure exerted on FDA to finalize its guidance.

In 2013, FDA released a finalized version of the guidance. Here's my take at the time.

In 2014, FDA released a new draft guidance about Medical Device Data Systems. As I noted at the time, this guidance significantly downgraded the regulatory status of MDDS, essentially shifting the entire category of apps from the group of apps where FDA would focus its regulatory attention to the group of apps where FDA would exercise "regulatory discretion," i.e., choose not to enforce regulatory requirements.

In addition, this guidance also by extension altered the finalized mobile apps guidance, and though I agreed (and continue to agree) with this decision, I mentioned that this created an odd situation for those relying on FDA's guidance. We had a new draft guidance about MDDS, which was making revisions to the mobile apps guidance, without any indication in the mobile apps guidance itself that it was undergoing a revision.

Instead, FDA is maintaining a separate, real-time listing of apps that it is updating as individual classification decisions are being made.

I applaud this innovation. I think it helps industry tremendously to have FDA maintaining this consolidated listing of decisions, especially because (as the MDDS guidance itself shows), FDA is willing to reconsider these decisions as the technology evolves.

The wrinkle is that you have to keep on top of these process issues closely to understand them. Otherwise, you'd find yourself going to the guidance, which was always kept in its final status, and assume that you were reading FDA's current thinking about a topic without realizing that FDA had released other, newer guidance that contradicted the position from the "final" guidance.

Well, as of February of this year, that discrepancy has been resolved. FDA finalized the MDDS guidance, and at the same time (apparently), released an updated final mobile apps guidance.

In reading through the new version of the final guidance, it does not appear any significant changes have been made to the FDA's classification scheme for mobile apps, or any additional reclassifications have been introduced; however, if anyone finds such changes, please point them out in the comments.

* I'm posting this (and other) guidance on my own site. My sharing these documents should not be construed as endorsing the views set forth in it, nor should it be taken as a sign that these views represent FDA's current position. This link is merely being provided for historical research purposes and use by others who would like to see how FDA's position has evolved.
**According to both FDA and press, FDA has been clearing (i.e., regulating and accepting apps as medical devices) since at least 1997.

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. 

FDA Updates Mobile Apps Guidance DHLB Regulatory Alert Available

Updated to correct important error: Correcting "not" to "now" in opening paragraph.

On Friday, CDRH came out with a new guidance that included revisions to the previously finalized guidance from September 2013 about mobile medical apps. The most significant aspect of this guidance is that systems that simply transfer medical imagery and data from one platform to another will now face a significantly lower regulatory burden.

You can read the Digitas Health LifeBrands Regulatory Alert about this guidance here.

In many ways, this activity was foreshadowed by the update made earlier this week to the list of mobile apps that would receive enforcement discretion.

On a tangential note, the recent activity from CDRH on this topic is welcome because, in my view, it correctly demonstrates a willingness to update FDA's position as new information is released, but it does present some challenges for industry and some problems with the existing Good Guidance Practices, and FDA is clearly aware of some of these difficulties.

According to GGP, Guidances must be released in draft status with an initial period of comment of at least 90 days. Then, FDA has the option of finalizing the guidance unaltered, updating the guidance and releasing a revised draft, updating the guidance and releasing a final version, or doing nothing (in which case the guidance stays in draft status).

What we have in this case is FDA proposing a new draft guidance with edits to a previously finalized draft guidance, and at least as of today, there's nothing in that finalized guidance to indicate to readers that it no longer represents FDA's current position. I understand the desire to not retract a final guidance or change it back into a draft guidance for every update, but in this case, someone could easily read the final guidance and not realize that it is outdated.

It seems the far better practice is what CDRH is actually adopting, namely, maintaining a webpage that is more easily updated that a formal guidance document, but the status of the webpage versus the guidance documents themselves seems to create some tension.

Perhaps moving forward, FDA should limit the guidance documents themselves (because of the time-consuming process needed to update them) to the principles FDA is applying with more easily updated lists referred to in the guidances themselves.

Of course, if FDA's view about the regulatory status of a product, device, etc., is subject to revision too frequently, then clearly there's a deeper issue that needs to be addressed.

Busy Week in Rockville (and Philadelphia)

CDRH has released a new draft guidance about mobile medical apps. Here it is.

I'm reading now and will have more later.

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.

FDA will not regulate Apple's HealthKit

In case you missed it, FDA has been updating its list of mobile apps where it intends to exercise enforcement discretion (on that concept in the FDA guidance on mobile apps see here and here). MobiHealthNews has a more extensive story here.

The most significant fact is that FDA has apparently added a new category that seems designed explicitly to include Apple's new HealthKit that was announced on the WWDC a few weeks ago.

h/t @wapgeekboy