How do currently available pharmaceuticals indicated for adolescents (<18) market to the adolescent audience?
Three examples of pharmaceutical companies marketing their products to the adolescent market include the development of educational materials, the sponsorship of medical condition-themed comics, and the development of apps for children and adolescents. A deeper dive of my research is below. Currently, the FDA does not regulate pharmaceutical marketing to children, but its industry association, PhRMA has created guidelines for where advertisements for medications should be placed. The FDA is, however, studying the impact of direct-to-consumer (DTC) advertising on adolescents, which could lead to further regulations in the future. A deeper dive of my research is below.
A challenge that pharmaceutical companies face when marketing products indicated for adolescents is getting them in front of the intended market. Both Pfizer and Reckitt Benckiser have found a solution to this problem by creating educational materials on health-related topics and distributing them to schools to administer to students. For example, Pfizer has developed an entire lesson plan about meningitis, complete with a teaching kit, four activities, a wall poster, and parent materials. It is no coincidence that Pfizer also sells Trumenba, a meningitis B vaccine; however, the materials are distributed through "Young Minds Inspired," an organization of "award-winning curriculum experts" rather than coming directly from Pfizer itself. The only indication these materials are sponsored by Pfizer is that its logo appears in the lower right corner of the worksheets and the call to action for students to "check with [their] doctor about getting vaccinated against meningitis B." This is because there is a perception that "drug companies obviously have a conflict of interest when it comes to what they’re going to say."
Reckitt Benckiser, the manufacturer of the over-the-counter acne treatment, Clearasil, has no such qualms about having its name on its educational material. Its puberty education worksheets, one for girls and one for boys, include the web address for Clearasil at the bottom of each worksheet page, along with various tag lines including "Clearasil for confidence...because you don't have to face puberty alone" and "Clearasil for clear skin...because it zaps the zits fast." These worksheets have also been created by the curriculum experts at Young Minds Inspired, but its "YMI, Inc." logo is tiny compared to the overt Clearasil plugs.
Jumo Health is a company that creates comic books that are meant to "empower children living with medical conditions." The company also creates a variety of resources for both children and parents, including apps, videos, podcasts, and games. However, pharmaceutical companies can pay for comic book editions that feature conditions for which they have medications. For instance, Shire, the pharmaceutical company that developed Aderall, the signature treatment for Attention Deficit and Hyperactivity Disorder (ADHD) sponsored several Medikidz comic books that discuss ADHD both from a sufferer's perspective and from other children's perspective. Medication names are never mentioned in the comic books, but the pharmaceutical company's name and logo appear on the back cover. In addition, the comic books do "extol the potential benefits of medication, but [they] also talk about side effects and advocate therapy and counseling" in accordance with FDA regulations that state both benefits and potential side effects must be presented in any drug advertising.
Horizon Pharma, the maker of several urea disorder medications like Ravicti, also uses Jumo Health to subtly advertise its products to adolescents and their parents. It has sponsored an app called "Medikidz Explain Urea Cycle Disorders," and its name appears several times on the web page describing the app. Children who use the app can read a comic about Kyle, an adolescent living with a urea cycle disorder, or play a game that features superheroes and an "adventure through Mediland to explain all about Urea Cycle Disorders." The only mention of a drug is when "a superhero explains that medication for the condition is available in powder, tablet, or liquid form, but that the doctors will keep a close eye on you to make sure your treatment is working." Jumo Health says its products do not represent a conflict of interest because "there is never any mention of a specific medication."
Other pharmaceutical companies have taken a more direct route to its customers by developing apps that meet adolescents where they are in the digital world. OXY, the maker of OTC skin care products and acne medications, has developed an app called "The 28-Day Challenge" to "help kids clear up their acne in time for prom." The company is not attempting to hide its intention to market its products through the app, as it even issued a press release announcing the challenge, saying the app provides "teens with accurate and realistic tools to clear acne-prone skin." The app features a "personalized, dermatologist approved acne skin care regimen, daily tips to help maximize treatment results, daily alerts to ensure that treatment stays on track, and [the] ability to take before, during and after pictures to show progress." Although teens cannot purchase OXY products directly through the app, they can download coupons to buy acne medications in-store.
Sanofi, a pharmaceutical company that manufactures numerous drugs, including those for diabetes, has also taken the direct approach toward marketing to children, although its free Android app, Mission T1D is designed to help kids with type 1 diabetes manage their condition in an engaging way. According to the app's website, it is "an innovative solution from Sanofi Diabetes, dedicated to helping enhance communication, understanding and relationships between young people living with type 1 diabetes and the people around them." There is no overt advertising in the app, but Sanofi is identified as the developer both on the website and on the app. The company does make it clear that it "does not access, collect or process any personal information related to you, such as your name, telephone number, e-mail address, date of birth, etc…, either through the downloading of the Application or during its use." As such, it is not as much a marketing tool as it is a way to keep its name in front of parents of children with diabetes.
The FDA does not currently have any pharmaceutical advertising regulations directed specifically toward children and adolescents. OTC drug advertisements do not require FDA oversight at all and the organization cannot compel drug companies to submit ads for approval before they are used. However, the regulations that apply to all prescription pharmaceutical advertising include:
1. There must be at least one approved use for the drug
2. The generic name for the drug (not just the brand name)
3. All risks of using the drug
In addition, certain regulations apply only to specific types of advertising. For example, medication inserts must include "the most complete information about a prescription drug," which means there will be "technical information about the chemistry of the drug, its proper use overall and in specific types of patients, and details about possible side effects." DTC ads must include a "brief summary," which will include "all the risk information about a prescription drug and is generally based on the prescribing information." Broadcast advertisements have more stringent regulations including the mandate that they include information that will allow the "audience to find the drug's prescribing information."
The most important federal regulation is known as "Fair Balance." This means that all "product claim ads give a 'fair balance' of information about drug risks as compared with information about drug benefits. This means that the content and presentation of a drug's most important risks must be reasonably similar to the content and presentation of its benefits." Even in pharmaceutical company sponsorship of comics and worksheets are subjected to this requirement.
The Pharmaceutical Research and Manufacturers of America (PhRMA) is the trade organization for "the country’s leading innovative biopharmaceutical research companies," and it has worked closely with the FDA to develop guidelines for advertisement placement. There are currently no specific guidelines regarding children, except to state, "DTC television and print advertisements should be targeted to avoid audiences that are not age appropriate for the messages involved. In particular, DTC television and print advertisements containing content that may be inappropriate for children should be placed in programs or publications that are reasonably expected to draw an audience of approximately 90 percent adults (18 years or older)."
Overt pharmaceutical advertising to adolescents has caught the attention of the FDA and there is currently a study underway that "assesses adolescents’ perceptions following exposure to DTC prescription drug advertising that varies in benefit and risk onset and risk severity." The administration states there is evidence that makes a "strong case for treating adolescence as a unique life stage during which vulnerabilities that can affect informed decision-making must be taken into account." This study, which began in 2016, is still ongoing, but could lead to further FDA regulations concerning drug marketing to adolescents in the future.
Both OTC and prescription drug companies market their adolescent products directly to their audience through educational material, comic books, and apps. There are currently no FDA regulations prohibiting DTC marketing to adolescents, but the administration is studying the effects of such advertisements and could increase regulations down the road.