FDLI MEMBER MAGAZINE | WWW.FDLI.ORG | MARCH/APRIL 2016 FOOD AND DRUG LAW INSTITUTE IN THIS ISSUE Advertising, Antitrust, Labeling, Biosimilars, Cybersecurity, First Amendment, Data Integrity, DQSA 2016 Annual Conference, May 5-6 Plus Interview with Mark McClellan Managing the Risks Embedded in Embedded Marketing: Five Things Every Manufacturer of FDA-Regulated Products Should Consider By Raqiyyah Pippins and Vernessa Pollard n an episode of a medical-themed network drama, a star Does this practice—commonly referred to as embedded athlete is rushed to the hospital with a broken arm. Test marketing—constitute advertising and if so, to what extent Iresults show that the athlete is also suffering from several can the manufacturer of Brand Drug A be held liable for the other conditions, including kidney failure, liver damage, fictionalized representation of its drug and its effects in this and hypogonadism. The lead character, who happens to TV show? be a brilliant doctor, questions the athlete’s steroid use. A marketer for a conventional food and beverage company Not believing the athlete’s denial of steroid use, the doctor works with a magazine publication to have an ad for a decides to treat the athlete’s hypogonadism with Brand branded cranberry juice product placed in an upcoming Drug A. Brand Drug A is mentioned four times during issue. e publisher mentions that one of its journalists will the episode. The manufacturer of Brand Drug A paid the also be writing an article on urinary tract infections and the network to integrate its product into the highly rated prime- marketer mentions the common use of cranberry juice as a time network drama, but did not review the final script. home remedy. e nal publication includes an article on Raqiyyah Pippins is Counsel at Arnold Vernessa Pollard advises companies & Porter where she represents the food, on regulatory, compliance, enforcement, dietary supplements, drugs, cosmetics, and legislative matters involving and medical devices sector. She also pharmaceuticals, medical devices, counsels organizations facing advertising mobile health and health IT solutions and challenges, and defends companies in services, and software. government agency investigations of product marketing practices. 4 UPDATE March/April 2016 fdli.org Advertising urinary tract infections that mentions movies or other otherwise independent ensuring that the messages conveyed cranberry juice as an eective home communications without any about the products are truthful and remedy. e next page includes an discussion of the product or its benets. non-misleading. While the rst advertisement for the company’s In contrast, product integration occurs priority applies equally to all consumer branded cranberry juice product. To when there is discussion of a branded products promoted through embedded what extent, if any, is the company product or product category in the marketing techniques, the second liable for any implied messages communication. priority introduces considerations that conveyed by the article that its product Advancements in technology (such are unique to manufacturers of FDA- can be used to relieve urinary tract as DVRs and streaming services) have regulated products, who must also infections? enabled consumers to avoid traditional avoid promoting their products for an While the standards governing most commercials. As a result, companies unapproved intended use. forms of advertising are generally are using embedding marketing ree federal agencies share understood by companies, the rules strategies to reach consumers. While jurisdiction over embedded marketing governing embedded marketing use of testimonials and product activity and thus should be considered strategies are more nebulous. is placement has been commonplace when developing a promotional article discusses relevant regulatory for decades, there has been a striking strategy involving consumer standards that manufacturers of FDA- increase in the use of integrated testimonials, product placement, or regulated products should consider product messages in scripted television product integration—the Food & Drug before implementing embedded and movie programs. According to PQ Administration (FDA), the Federal marketing-centered promotional Media, television script integrations Communications Commission (FCC), strategies. accounted for more than two-thirds and the Federal Trade Commission of $6.01 billion spent on product (FTC). Each is discussed, in turn, 1 Embedded Marketing placement and integration in 2014. below. in the United States Investment in digital media integration is also growing exponentially, For the purposes of this article, Food & Drug increasing by 35.8% between 2013 and “embedding marketing” is the use Administration 2014.2 of or reference to a product, service, FDA is responsible for protecting the or trademark in a commercial public health by assuring the safety, communication by an otherwise Regulatory Response ecacy, and security of FDA-regulated independent third party in exchange to Embedded Marketing products.3 In light of this responsibility, for payment or similar consideration. Because the ultimate goal of these FDA has growing concerns about the It can take many forms, the most new marketing techniques is to accuracy of consumers’ understanding popular of which are celebrity capitalize on consumers’ attention of risk communications as well as endorsements, product placements, and identication with their favorite ensuring that companies comply and product integration. Generally, characters or programs, regulators with requirements applicable to celebrity testimonials involve payment are necessarily concerned about the the objective intended uses of their or an in-kind exchange between a potential for consumer deception. e products and do not promote their company and a celebrity to discuss potential blurring of lines between products for unapproved uses. FDA has the product, such as when a celebrity purely promotional or commercial conducted several consumer perception appears on a television news program messages and artistic, educational, studies over the past few years to to discuss a project or book and or informational speech touches assess consumer understanding of simultaneously extols the benets of upon two enforcement priorities for representations regarding prescription a particular product in an otherwise federal agencies: (1) ensuring that drugs,4 which have inuenced the independent journalistic forum. consumers are aware that content development of new Guidance for Product placement involves the use of is sponsored (i.e., they know that Industry regarding consumer-directed a product in television programming, they are being marketed to); and (2) materials. While most discuss FDLI March/April 2016 UPDATE 5 Advertising prescription drugs, such as Guidance extent to which a company can be of FDA’s study on Disease Information for Industry, Brief Summary and held responsible for a message that a in Branded Promotional Materials and Adequate Directions for Use: Disclosing consumer takes away from two distinct should provide helpful insight into Risk Information in Consumer-Directed health-related communications that how FDA will approach embedded Print Advertisements and Promotional are displayed in the same publication marketing strategies involving FDA- Labeling for Prescription Drugs, they or program and assist the agency with regulated products. provide helpful insight regarding how updating its 2004 Dra Guidance for Risk communications are another FDA would treat embedded marketing Industry, “‘Help-Seeking’ and Other key priority for FDA and the agency techniques involving any FDA- Disease Awareness Communications has made clear that it expects regulated product. by or on Behalf of Drug and Device companies to provide truthful and For example, in a 2012 submission Firms.” In the 2004 Dra Guidance, balanced information about the for Oce of Management and Budget FDA took the position that disease risks associated with FDA-regulated (OMB) Review of an experimental awareness communications were products, regardless of the platform. study regarding disease information outside the scope of FDA’s regulatory For example, in its June 2014 Guidance in branded promotional material, FDA jurisdiction and would not be treated for Industry, Internet/Social Media hinted that it has concerns regarding as advertising or labeling unless (1) the Platforms with Character Space the messages conveyed when an FDA- communication was combined with Limitations—Presenting Risk and regulated product is placed in close reminder advertising or labeling or (2) Benet Information for Prescription proximity to content discussing disease was in some other way “determined Drugs and Medical Device, FDA states that are also associated with to, by implication, identify a particular reminded companies that “[w]hen symptoms for which the product is not drug or device” in a manner communicating benet information approved for use in the United States. that caused FDA to consider the about its product, a rm should ensure In pertinent part, FDA noted: communication labeling or advertising. that benet information is accurate When broad disease information In pertinent part, the dra guidance and non-misleading. In doing so, accompanies or is included in an document included a discussion of the rm should also reveal material ad for a specic drug, consumers instances where “supposed disease facts about the use of its product, may mistakenly assume that