Joan M. Lebow, Partner, Edwards Maxson Mago & Macaulay LLP, and Anu Dairkee, MD, 3L, Loyola University Chicago School of Law, discuss direct-to-consumer (DTC) advertising, the importance of health literacy in pharmaceutical advertising to patients, disparities created by decreased health literacy, how the pharmaceutical industry is using social media to increase the DTC advertising space, and the state of current regulations. Joan and Anu recently authored an article for AHLA’s Journal of Health and Life Sciences Law about this issue.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
Joan M. Lebow, Partner, Edwards Maxson Mago & Macaulay LLP, and Anu Dairkee, MD, 3L, Loyola University Chicago School of Law, discuss direct-to-consumer (DTC) advertising, the importance of health literacy in pharmaceutical advertising to patients, disparities created by decreased health literacy, how the pharmaceutical industry is using social media to increase the DTC advertising space, and the state of current regulations. Joan and Anu recently authored an article for AHLA’s Journal of Health and Life Sciences Law about this issue.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
This episode of A H L A speaking of health law is brought to you by A H L A members and donors like you. For more information, visit american health law.org.
Speaker 2:Hello, everyone, this is Joan Lebo. I am co-presenting this podcast with Anu Darky, and she will, uh, follow me and introduce herself in just a moment. I'm a partner at the law firm of EM three in Chicago. We are a minority owned full service firm. We have a, um, focus in healthcare, and that has been my professional focus since, uh, since I was graduated from law school many decades ago. My first position as a lawyer was with what was called at that time the Illinois Department of Public Aid. The, um, medicaid agencies, as we all know throughout the United States, have changed dramatically over the past, uh, decades. My first position involved prosecution on an administrative level of, uh, providers involved in Medicaid fraud and referral referral of those providers to the US Attorney's Office. Since then, I have, uh, been, uh, uh, almost evenly in-house and in private practice, uh, and all the while again focusing on healthcare. I was the general counsel of a large teaching hospital here in Chicago for many years, and prior to that was on the legal staff of a even larger teaching hospital here in Chicago. My last in-house position was with a software company that was a seller of, uh, focused applications to the physician and, uh, hospital system marketplaces. And that software application is now rolled up into UnitedHealthcare's, uh, software. I am a member of the board of the Illinois Association of Healthcare Attorneys, and I am a adjunct faculty member at the University of Illinois School of Public Health in the Masters of Healthcare Administrative Program. Since leaving my last in-house job, I've served as, uh, a partner in several law firms here in Chicago, and our practice has encompassed, um, multidisciplinary, uh, provider groups, uh, global public and startup it, and other digital media companies in healthcare focusing primarily on transactions and compliance. I was in the very beginning of my private practice career, a co-founder of my own certified women owned law firm in Chicago and Oakbrook, Illinois, where we also focused on healthcare anew. I'll turn it over to you.
Speaker 3:Thank you, Joan. Hello everyone, and thank you again for joining us for this episode of Speaking of Health Law, a brief introduction about myself. Uh, my name is Annu Dki, and I am currently a third year law student at Loyola University Chicago School of Law. I will be graduating in May, 2023 with the certificate in Health Law and Compliance Studies. I'm excited to join Joan and other legal practitioners in the dynamic field of health law in hopefully the near future. Um, a little bit more about myself. I'm, my interest in health law grew from an interest in increasing access to quality healthcare for all Americans, and a desire to simplify the practice of healthcare for practitioners in the United States. While I've been in law school, I focused on projects that have increased health equity and addressed physician concerns about workplace issues. Prior to joining law school, I was a physician and I worked with a team to develop a clinical order set, uh, that's being used in a hospital system in Ontario, Canada for patients presenting with hematological disorders. My focus in medicine was on clinical research that improved both the efficiency of the admissions process and patient outcomes. So, moving on to our podcast here, um, in October, 2022, the A H L A Journal of Health and Life Sciences Law published a brief insight that we authored. That brief insight is the basis for this episode of the Speaking of Health Law podcast. We are incredibly grateful for the opportunity and are hoping that you, the listener, will be able to take something useful away from this episode. In this episode, we are bringing in part the learning from our article and expanding the area of learning with regards to health literacy. The episode will be divided into four areas. First, we will highlight some general background about direct to consumer, also known as D T C advertising. Just to give you some context about how D T C started and how far it's come. Then we will discuss health literacy and the crucial role that it plays in pharmaceutical advertising. When the messaging is directed towards a patient who is the end consumer, but quite honestly may not have the ability to understand the language that's being used in the ad, we will discuss the dis disparities that are created by decreased health literacy. We will then move on to discussing how the pharmaceutical industry is using social media to expand the D T C advertising space and the, the role that providers play in this. Finally, we will end our discussion on where regulations currently stand. So starting off with a little bit of general background about, uh, direct to consumer advertising. It started in the United States in 1981 when Merck debuted, um, the first D T C print ad in the United States promoting its pneumonia vaccine. In that same year, Liz Monch, during a job interview at, uh, boots Pharmaceuticals asked John Breyer, the company president at the time, to describe Boots main customers. Breyer responded to that doctors were boots, main CU customers, and, uh, Monch then wanted to know why it wasn't the consumer. MO has since said that it seemed so obvious that this was an industry that had totally missed its mark in engaging the people who were consuming their products, and that the patient is the ultimate consumer of the prescription medications. Since they, at the end of the day, are the end user. As such, she felt the consumers ought to be more involved in their treatment decisions. Needless to say, she got the job and the rest is history. On May 19th, 1983, boots aired the first broadcast television commercial in the United States for Prescription Drug Roofing, which was the brand name for Ibuprofen at the time, at the time that Boots Air, the, the Boots ad aired f d a regulations for how drug makers could advertise their products had not been updated since the 1960s before airing the ad boots was informed by the F D A that the AD needed, quote unquote fair balance, which was the standard for an accurate assessment of a drug's risks and benefits that governed other drug promotion following the release of the Boots ad in 1984, and Eli Lilly executive said, uh, in a letter to John Dingle, who was then the representative of Michigan, and as some may know, he was a champion of truth and science and a leader in the creation of Medicare and Medicaid, that Eli will said that these types of drug promotions would be both unwise and inappropriate. In 1985, the F D A said that drug makers could air ads, but they also had to follow rigid rules for disclosing side effects and other information. Then in the mid nineties, sharing plows started trying to push the envelope when airing ads for Claritin, where they never said what the drug was for, but instead implored viewers to talk to their doctors about Claritin. Moving on to 1997, the F D A decided to relax its rules in their TV spots. Drug makers could now ref refuse re refer viewers to print ads. They could offer 1-800-NUMBERS or websites and urge people to talk to their doctors if they wanted that additional information that the, the F D A had previously required ads to have. This change allowed drug makers to air more product focused ads that made specific medical claims for the advertised drug. These are the kind of pharmaceutical ads that now dominate the airwaves worldwide. There are currently only three countries that allow direct to consumer advertising in the pharmaceutical space, the United States, Canada, and New Zealand, Canada has significant restrictions on what can be included in a pharmaceutical D T C advertising, and the US has a least restrictions regulatory level with regards to this type of advertising. The lack of more current and pertinent regulations or guidance have left the direct to consumer advertising space looking like the Wild West. I will now pass it over to Joan.
Speaker 2:Thank you, Annu. We've, uh, as Annu mentioned, decided to include, uh, a discussion of health literacy in this, uh, podcast for the very simple reason, uh, it that we think that this subject matter in its entirety needs to be incorporated. Um, at the basic level and at the most sophisticated level of, uh, discussion regarding social media usage by, uh, uh, the pharmaceutical industry. We've taken much of our, um, uh, learning from the Organization for Economic Cooperation and Development, which is an, uh, international N G O that specializes, uh, in, uh, social policy and, and focuses heavily on education. And also, uh, from, uh, the, uh, O D P hp, which is a, uh, a subunit of the C D C. So according to the Organization for Economic Cooperation and Development, the O E C D half of adults in the United States cannot read at the eighth grade level. The, um, more finely, uh, and more granular research results from their studies, um, are reported in something, uh, by, by, uh, an organization called the Literacy Project, which has, um, uh, concluded that, uh, the average American reads at the seventh to eighth grade level. However, these same organizations have, um, found that those are the highest reaches of, um, the largest or preponderance of Americans, so that only 36% are reading at this intermediate level. Uh, the rest of the population is reading, um, at a very low level, lower limited level. Uh, so we've got breaks between the seventh and eighth grade, and those are low and limited, uh, uh, proficiency readers. And we've got, uh, fully a third of the American adult population reading at the low and limited level. Low health literacy is associated with patients who are older, have limited education, lower income, chronic conditions, and those who are non-native English speakers. So in transitioning to a, a discussion of health literacy from a discussion of literacy, generally, we, we hope to bring, uh, this focus into, uh, the framework of our discussion regarding social media usage by the, um, pharmaceutical industry. Approximately 80 million adults in the United States are, uh, estimated to have limited or low health literacy, and those factors that I just delineated are, uh, contributing or are, are causative of that. There is very little known with respect to, uh, health literacy, uh, in minority populations. Um, but we do have, um, uh, a very significant initiative, uh, called Healthy People 2030 that's been promoted by the C D C in connection, of course, with the pandemic, uh, literacy and health literacy were, uh, um, understood quickly by the C D C as being, uh, key, uh, tools in their arsenal to, uh, distribute, uh, valid information about, uh, covid itself and, um, uh, about, uh, risk mitigation, uh, behaviors and, um, vaccines that could be used by the American public. So they've defined personal health literacy, as in part, the ability to find information. They've in, they've further defined organizational health lit literacy to, um, include the, uh, equitable enablement of in individuals to find, uh, health information. So you can understand that from the CDC C'S perspective. The, um, the pharmaceutical industry, along with the institutional healthcare delivery system, have, um, the responsibility to examine how health literacy, um, is connected to disparate, um, uh, outcomes for people of color and non-native English speakers here in the United States. Those same organizations make a very profound distinction between health literacy and e-health or digital health literacy. This distinction was recognized in a very, um, broad 2017 study showing that social media campaigns overlook, uh, unique cultural and language, um, differentiators of segmented populations and do not apply health literacy populations, excuse me, health literacy principles to those populations, better known as knowing your audience. Social media is a way to reach vulnerable populations in persons who are most impacted by health literacy barriers. For example, low income and rural Americans rely on smartphones to access the internet and are more likely to use a smartphone to look for information about life and health decisions, such as their own individual and family health conditions. 40% of adults in rural communities use at least one social media site. 15% of Americans ages 18 to 29 RO 29 rely on a smartphone for online access. As do 13% of persons with a yearly household income less than the fa federal poverty level. The use of smartphone friendly social media additionally provides a means to reach minority audiences, and, um, uh, at least two times the number of, uh, uh, black and latino citizens of the United States rely on a smartphone compared with, um, reliance by, uh, white, uh, uh, white persons in our society. This 2017 study was, um, very unique at its in its day, but several more studies have followed, including a multi-institutional Harvard based study of information seeking behavior online and health literacy. This Harvard study concluded that health information and healthcare are both increasingly being delivered online. Their research showed that four out of five Americans are currently using the internet for health related purposes. So you can see the phenomenal and exponential growth between those findings in 2017 and the findings in this study, which was published in 2022. Nearly half of the adults in the 2022 study reported using the internet com to communicate with their providers, and more than half looked for information about all sorts of healthcare conditions for themselves and for loved ones. This 2022 study found that health related internet use among adults increased with age until about the age of 38, when it decreased steadily and then picked up again at age 71 and increased again year to year. People who reported poor or felt fair health status had higher health related internet use scores than people who reported good, very good or excellent health status. And the authors of this study speculate that the access of people who have, uh, good, very good or excel excellent health status and the self-report, um, uh, is caused by the fact that they have more, um, consistent and higher quality actual access to healthcare service from their providers. Very little research has focused on numeracy or valid assessment tools for, uh, uh, eHealth literacy or digital health literacy. Facebook has been studied the most in the US as the SOL social media platform of choice for healthcare, and around 40% of adults gathered their healthcare information from Facebook as measured in 2013, and we know that that has dramatically increased. Most healthcare companies have Facebook pages, and it has been important to be active on these networking PLA platforms as fully half of consumers found their health related treatment reviews of choice in the year 2022. As Anus said, our goal is to examine the ways that social media can enhance the distribution by pharmaceutical manufacturers of data about their drugs. Objective research on how consumers ingest data distributed by influencers through social media is needed. The f d A study, that was the genesis for the article, that the A H L A published, which we co-authored may contribute to this, but we believe a very much larger and comprehensive study is needed that will deploy current neuroscience and measure and, and report on how consumers understand social media in its portrayal of information concerning, uh, pharmaceuticals an
Speaker 3:Yes. So now that Joan has spoken a little bit about social media, I'd like to dive a bit more into that. So everybody here today is, uh, listening to podcast online. You're probably a user of social media, but to put it more into perspective, I wanted to use a statistic currently 3.6 of seven of the 7.8 billion people on Earth, which is roughly half the world use social media, and the numbers continue to grow as more people gain access to the internet. Given this increased use of social media, it seems only logical that the pharmaceutical companies industry would use this medium to advertise. Today's drug development process is more collaborative than ever before, and patients insights have become more sought after. This has put social media in the forefront as a good way for pharmaceutical companies to glean and disseminate information. As Joan mentioned, Facebook is primarily used by pharmaceutical companies to advertise their drugs, and Facebook is an excellent example of a medium that is perfect for advertising pharmaceutical drugs, pharmaceutical products. The reason for this is that Facebook can handle various types of content, and it is perfect to drive brand awareness. Spending on Facebook mobile ads by pharmaceutical and healthcare brands alone reached nearly a billion dollars in 2019, nearly tripling over two years. The same Facebook systems that help place an ad for a political campaign or a new shoe in a user's feed also can be used by pharmaceutical companies, allowing them to target consumers who match certain characteristics or have visited a particular website in the past. To note, Facebook does restrict the promotion of health and pharmaceutical products and services and requires permission for this advertising, and I will go into this a little bit later. Other social media platforms that are being used by pharmaceutical companies include Instagram and Twitter. Instagram is aimed at a young, younger demographic than Facebook, where 71% of the users on Instagram are in the 18 to 29 age group, and Twitter is also a great platform to reach a young, younger demographic and helps build brand awareness as long as the content is visually engaging. Twitter has an active user base of 353 million people, and according to the Pew Research Center, 23 per percent of Americans say they use Twitter every day. Pharmaceutical companies have found that social media is an effective way of delivering messaging to consumers that can have an immediate impact on their care, and Twitter is a wonderful medium to use, but Twitter, like Facebook restricts the promotion of health and pharmaceutical products and services, and a company that wants to promote on their platform requires permission prior to running the ads. LinkedIn is a major outlier among social media platforms. LinkedIn does not allow ads related to prescription pharmaceuticals, drugs, or any related products or services. Ads that promote prescription or over-the-counter drugs are prohibited on LinkedIn. So with LinkedIn, pharmaceutical companies need to get creative with content. They focus less on the product or service they are selling, and more on the company itself. Examples of ways in which pharma has used LinkedIn include press releases such as new plant openings and recent awards, insights into the company through a virtual facility or a tour of, um, or a virtual facility tour, or an interview with a top scientist of the company are also ways in which pharmaceutical companies have used LinkedIn. Pharmaceutical companies leading the social media charge recognize that each forum has its benefits. Pfizer, for example, uses Facebook for more consumer-oriented patient policy and r and d information, and they've used LinkedIn to talk about their people in science. Eli Lilly in a recent example, using their Twitter handle at Lily Pad announced in the March, 2023 that it is reducing out-of-pocket costs for people using Humalog, which is Lilly's branded insulin. They're reducing the out-of-pocket cost, the$35 per month for consumers that are uninsured or use commercial insurance. In this Instagram post, in this Twitter post, Lilly included a clickable link that leads users to a page that details how they can take advantage of this price decrease. Using social media in this manner brings the benefit of informing consumers and providers as quickly as possible, and in this case, allowing patients with insulin dependent diabetes to access vital medication at a decreased cost. Examples of pharmaceutical companies using Instagram include campaigns that took advantage of the public interest in cannabis-based medicines and created content around that area. Merck has used Instagram to amplify key disease facts, conduct geotargeting around college campuses, and to partner with influencers. Pharmaceutical companies are using their social media presence to build a presence that goes beyond marketing a product, to promoting experiences that help people manage their conditions and connect patients with healthcare professionals, associations, communities, and others that can aid them through their their entire treatment journey. Now, the pandemic changed the way in which the pharmaceutical industry had to approach advertising in social media. The reason for this was largely that people were staying away from doctor's offices because of this new diagnoses were being depressed, which in turn decreased new drug prescriptions. So Pharma used this opportunity to run campaigns that boosted awareness in education, and they changed their tactic when approaching patient populations. They publicized their role in fighting Covid 19, mainly through educational campaigns about vaccines and covid tests and awareness campaigns about how their core technologies were aiding in the fight against Covid 19. Due to the pandemic, pharmaceutical companies like Regeneron use the opportunity to remind patients that conditions such as diabetic retinopathy could worsen, if not treated properly. Regeneron developed ad campaigns where people could get more information on the drug Eylea, which is used to treat diabetic retinopathy. Prospective customers were able to take a quiz to gauge their eye health, and then were given a list of what questions patients should ask their doctor to determine if the medication was right for them. Regeneron also included a Spanish language website for Eylea to improve awareness among the Latino community whose members are more likely to develop diabetic retinopathy and less likely to be screened. Pharma also spent big during the pandemic on unbranded advertising. Examples of these include Eli Lilly's Unbranded Olympic campaign, which raised awareness of disparities in US healthcare and Pfizer's Science will win campaign given that pharmaceutical companies have actively used social media for direct-to-consumer advertising. The question begs asking, have social media companies developed any rules to self-regulate pharmaceutical advertising? And the answer is a resounding yes. Meta Facebook's parent company has developed specific requirements for advertising pharmaceutical products. For example, promoting prescription drugs is not allowed without ri prior written permission from meta. An eligibility to promote is limited to online pharmacies, telehealth providers, and pharmaceutical manufacturers. For an entity to apply for permission, an entity needs to complete the prescription drug advertiser application, and Facebook has also created rules that pharmaceutical companies must comply with when promoting their products on the platform. These rules can be found on their website, and in addition, on a supplemental information sheet that we will be posting to each of our LinkedIn profiles. An important safe harbor to note that Facebook has created is that advertisers do not need written permission to run ads that only educate, advocate, or give public service announcements related to the prescription drugs or advertisements that promote telehealth services. Generally, this is similar to the ads that most that a lot of pharmaceutical companies ran during the pandemic that were more public service oriented and less focused on a specific drug. Now that we've discussed, now that I've discussed a little bit about how pharmaceutical companies have used social media to target consumers, I'd like to explore how social media, how pharmaceutical companies are using social media to target providers across all age groups. Four out of five doctors use social media in their practice with 56% using healthcare personnel only networks like Sermo and Doximity, and 32% using open networks like LinkedIn and Facebook. For millennial doctors, those numbers are even higher. 87% of them use social media and four out of five of them who use social media read medical news updates through their social newsfeeds. It is possible for an individual doctor through gaining followers and posting the right content to wield as much influence on a social network as a major medical school or a Fortune 500 company. Pharmaceutical marketing now has a way to be hyper targeted through targeted advertising inside work platforms that are used by doctors. There's two key factors that influenced this change in pharmaceutical marketing. The first was the acas push to digitize patient health records, and the second was the realities of the pandemic, which precluded drug sales rep from visiting doctor's offices and hospitals. Ogilvy Health's point of care division launched a strategic partnership with Doc Care, which is a firm that offers demand and sell side ad tech for targeting pharma brand messages directly to specific physicians based on their identifiable doctor codes, their healthcare platform, login data, their medical expertise, even their prescribing history, and whether they prescribed the competitor's drug a moment ago to a patient who was still in the room. Doc care can target ads based on a doctor's previous prescription history, coupled with the fact that that physician is viewing the health records of a patient with a particular disease and is using the prescription flat platform to write that patient a script for a specific drug in that moment. Part of the draw for drug makers is the ability to measure not only what their ads inspire doctors to prescribe when hyper targeting them through eh h r systems, but whether people actually fill those prescriptions. Doc care also as partnerships with data suppliers, including kamodo Health and Symphony Health, and those suppliers provide information from insurance and Medicare claims and pharmacy purchase data to show how ad campaign campaigns affect so-called script lift, which measures the number of new prescriptions or gauges, the number of doctors who are new prescribers. Of course, healthcare data and targeting almost automatically raises the question, raises privacy questions, and Doc Care has says that they has said that they never touch any patient data and that their ad targeting system and data use is HIPAA compliant. Doc care has said that if ads are targeted when a doctor writes a prescription, the patient information is not visible to the system at the time the ad is targeted. But one of the very significant con considerations here is what does advertising directly within an E H R system do to the cost of our healthcare? Increased usage of social media by pharmaceutical companies combined with the use of social media on a personal and professional level by providers produces significant influence through social media on consumers choice of drugs and medical devices. Providers can be influenced via advertising within EH hrs and can themselves act as pharmac pharma influencers on social media platforms. Our healthcare delivery system deserves new rules and regulations regarding pharmaceutical direct to consumer advertising in the social media space with a particular attention being paid to health litera literacy concerns that Joan spoke about earlier. I will turn the discussion back over to Joan to discuss the regulatory landscape as it exists today and in the future.
Speaker 2:Thank you au. We, um, know that we have two different, um, uh, federal agencies that, uh, I won't say compete, but, uh, but that both regulate, um, social media, uh, disclosures by pharmaceutical manufacturers and others regarding products, and those are the FTC and the F D a. There is a vigorous debate among legal scholars about the, uh, efficacy of the F D A in this, um, endeavor, the regulatory endeavor, uh, since the teaching of, um, the many decades that have passed since the agency first, um, began to regulate disclosures to physicians remains in place and is, um, I would say, uh, somewhat, uh, behind, uh, uh, the current science in terms of, um, health literacy and, uh, digital literacy with regard to patients. So the F D A certainly plays a vital role in, um, regulating the disclosures to providers, but many legal commentators question its ability to play that same role with respect to, uh, social media and look to the FTC in its most current, um, proposed regulations as evidence that it has, um, uh, greater efficacy, uh, amongst, um, its, uh, uh, staff and, um, based on its history of enforcement in this regard. So, the FTC has long acknowledged, uh, the importance of accurately informing consumers on platforms like Facebook and Instagram. Graham. In treating an influencer's opinion as a trusted source of information, the FTC has recognized that brand relationship disclosure is crucial and necessary to ensure consumers can accurately evaluate and influencers endorsement. The FTC set this out, set this standard out in its supplemental regulations to the guidelines that were published in 2009, and those are meant to provide advertisers with a better understanding of compliance. Then in two, 2017, the FTC took actions against social media influencers who failed to disclose their brand relationships. The FTC has targeted brands that oversell their products through deceptive means. In 2020, the F T C acted against TMI L L C A detox T company for failing to require influencers endorsing a TMI brand product to accurately disclose their relationship with a brand. The FTC found that the through, although influencers had noted the brand relationship in their Instagram post captions, the disclosure was inadequate because it hid the caption behind a follower's initial view of the post. Thus, while the FTC ex explicitly recognizes that disclosures must be clear and conspicuous in text, they may must also be regular, readily apparent in their form placement within the social media display. In 2022. On June, 2022, the FTC pre-published updates to endorsement guides that have been in place since 2009. Of note, with respect to our focus on endorsers, um, is a proposed new regulation, uh, with respect to endorser liability. The FTC proposes adding a new section that would make it, uh, the endorser's, uh, potential liability for their own statements, such as a representation that they know or should know is deceptive or failing to disclose a material connection between themselves and an advertiser. This section would also address the due diligence that endorsers should perform before providing an endorsement with expert endorsers, such as physicians being held to a higher standard than non-expert endorsers under the current section of the guides. If an ad if an advertisement represents either by implication or explicitly that an endorser is an expert, then the endorser's qualifications must actually give the endorser the expertise that is represented. Experts must also use their expertise when evaluating a product or service, and the evaluation is expected to include an exam or testing of the product that's based on the same degree of expertise that they would normally apply, uh, in their own practice. As an expert in the proposed updated guidelines published in 2022, they, uh, the F T C proposes clarifying its guidance on expert endorsements in the sense of applying those new requirements to both express and implied representations. The F T C also proposes modifying, uh, examples so that an expert endorser, uh, must have a clear and conspicuous disclosure, uh, that, um, uh, their expertise is sufficient to evaluate the product under consideration. For example, the commission proposes amending, uh, to clarify that a doctor making an endorsement about a drug must review scientific e evidence that others with that same purported degree of expertise i e uh, medical degree would consider adequate to support the conclusion made in the advertisement. So this comes very close as you can appreciate to what you see in a, in a courtroom, in a medical malpractice, uh, a litigation setting known, uh, formally and informally as, um, the standard of care. If that doctor failed to, uh, uh, uh, meet that standard, they and the advertiser would be liable for false statements. So the additional responsibility that an expert endorsers would have as a result of these, um, uh, proposed regulations, um, uh, our even more particularly important when an expert is reviewing background materials prior to giving an an endorsement. In one of the examples, a dermatologist is a paid advertiser to a pharmaceutical company and asked to post about the company's products on that doctor's social media. The company provides that dermatologist with a writeup of a clinical study prior to the dermatologist posting that one of the company's products is clinically proven to work. The writeup of a clinical study in indicates the study was flawed in design and, uh, conduct and conclusions about the efficacy of the product are not accurate because the dermatologist has medical expertise. The dermatologist should have, according to the ftc, recognize the studies' flaws prior to post posting the endorsement, and is therefore subject to liability for those statements, which the FTC would determine to be false in that, in that situation. However, if that dermatologist had asked the company for supporting evidence prior to making the, uh, endorsement and the company withheld or, um, falsified such requested information, the doctor would have no liability. So our note that was published, uh, by the A H L A, uh, focused on the, um, c on the F D a, specifically the, uh, OPD P'S latest research endeavor, which are studies on endorser status and a driving force behind these, uh, studies, if is the FDA's awareness, the widespread use of endorsers in D T C advertising and their desire to improve how features utilize it US utilized in social media impact consumer's understanding of PR prescription drug risks and benefits. That being said, the pharma pharmaceutical industries, um, trade association, uh, made it very clear that they felt the study was outside the, um, purview of the F D A and and should have been closed. Um, so, uh, the protocol for the study is, um, very expansive. It intends to recruit, uh, influencers with Instagram followers that are followers of greater than half a million, and they have, um, a wide scope to the design of this study. The F D A has expanded its enforcement efforts, uh, to encompass advertising and promotion occurring on social media over the past many decades. One high profile, uh, example of this is featured in our note where Kim Kardashian, uh, promoted alegious a, um, morning sickness drug, but failed to include, um, risk information in that study, excuse me, in that social media post, a warning letter was issued to that manufacturer. Similarly, in 2014, the F D A sent a warning letter, uh, to, um, a manufacturer zaby, because it's post constituted endorsing or recommending a dietary supplement in the cure mitigation treatment or prevention of disease, which is of course, the legal scope of the FDA's mission. So those are examples of the FDA's enforcement, uh, and, um, uh, focus on enforcement in the social media space. And we also are aware that the F D A and FTC through their memor memorandum of understanding can work jointly, uh, and do work jointly, uh, to enforce, um, uh, disclosures and fair balance. In disclosure, in June, 2019, the F D A and F T C sent joint warning letters to e-liquid companies. Were reminding them to, uh, post conspicuously disclosures and, uh, noting that those brands should inform, should inform influencers of their disclosure responsibilities. We want to, uh, uh, identify to our listeners that we are all, um, we are all in on this topic, and as, uh, evidence of that we will be posting on our LinkedIn pages, um, further, um, resources and references for your use, uh, and many of them we ever lied upon in in our presentation today.
Speaker 1:Thank you for listening. If you enjoy this episode, be sure to subscribe to a H L A speaking of health law wherever you get your podcasts. To learn more about a H L A and the educational resources available to the health law community, visit American health law.org.