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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 on-demand 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.

Mar 28, 2024

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Joseph Nye argues that episodes of "declinism" say more about popular psychology than geo-political analysis, but they also show how the idea of decline touches a raw nerve in American politics. China is not an existential threat to the United States unless U.S. leaders make it one by blundering into a major war.

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Mariana Budjeryn writes that despite, or perhaps because, of this ever-present shadow of war, the 16th annual Kyiv Security Forum, which was held in March 2024, was a display of camaraderie and solidarity with Ukraine, with sincere dues paid to Ukraine's bravery, sacrifices, and resilience, as well as in recognition that Ukraine belongs in the transatlantic security architecture.

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Kyrgyzstan is currently at a critical geopolitical juncture in which it is forced to
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pressures towards autocracy. Once celebrated as the ‘island of democracy’ in Central
Asia, the small nation faces significant challenges in light of internal authoritarian
tendencies and external pressure following Russia’s full-scale invasion of Ukraine in
February 2022. This report, therefore, examines the role of Kyrgyzstan within the
global democracy versus autocracy debate that has intensified in the past two years
and assesses President Japarov’s neutrality with regards to Russia’s invasion and
Bishkek’s shifting allegiances.

This report relies on a qualitative methodology that builds on field research conducted
in Kyrgyzstan in August 2023. As such, this report incorporates interviews with
Kyrgyz civil society organizations and other stakeholders working on issues
including, but not limited to, democratization, corruption, human rights, media, and
the rule of law. The report presents an in-depth analysis of the Russian influence with
regards to the Kyrgyz political system, civil society, and strategic relationship with
Moscow, underpinned by the historical context of Kyrgyz-Russian relations.

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