American Journal of Law & Medicine

Celebrity Drug Endorsements: Are Consumers Protected?

I. INTRODUCTION                                              140 II. HISTORY OF DTC ADVERTISING IN THE UNITED STATES          141  A. THE RISING POPULARITY OF CELEBRITY ENDORSERS             142  B. CELEBRITIES AND DIETARY SUPPLEMENTS                      143 III. LEGAL RULES                                             144  A. FDCA AND FTC ACT'S ROLES IN REGULATING DRUG ADVERTISING  146  B. FDA'S DRUG ADVERTISING REGULATION                        147  C. FDA GUIDELINES ON DRUG ADVERTISING                       149  D. FTC REGULATIONS AND GUIDELINES ON DRUG ADVERTISING       152 IV. FURTHER ANALYSIS                                         153  A. A STRIKING BLOW TO THE FDA'S REGULATORY POWER: FIRST  AMENDMENT DEFENSES                                          153  B. THE UNIQUE PROBLEM ASSOCIATED WITH SOCIAL MEDIA          157  C. MONEY TALKS--BUT DO CELEBRITIES?                         158 V. CONCLUSION                                                160 

I. INTRODUCTION

"I'm not a scientist... We had no idea what was happening behind the scenes," claimed Olympic gold medalist Bruce Jenner. (1) Jenner was a paid endorser of the prescription drug Vioxx, an arthritis medication that was removed from the shelves when reports emerged that the drug had caused at least 160,000 cardiovascular events, including stroke and heart attack. (2) Jenner is merely one of the many athletes and celebrities enlisted to increase sales of pharmaceuticals, (3) a growing problem in the United States.

Though the debate over its merits continues, the United States is only one of two countries (4) to allow direct-to-consumer advertising, indicating a unique societal feature requiring close scrutiny. As the celebrity reach grows larger due to advances in social media and reality television shows, companies are increasingly utilizing celebrity endorsements of prescription drugs and dietary supplements. (5) Such endorsements can provoke controversy stemming from celebrity influence paired with the astronomical amount of money celebrities are paid to entice the general public to learn about, and ultimately use, such products.

Celebrity endorsements of everyday products, such as cosmetics and clothing, are common. However, in the realm of prescription drugs and dietary supplements, regulators should be more aware of the message being sent to the general public because of the increased sensitivity of, and risks associated with, such information. Prescription drugs and dietary supplements differ from other categories of products that celebrities endorse because of the risks associated with ingesting drugs and supplements. Presumably, a celebrity endorsement of a makeup brand or clothing line will not have the potential for serious adverse health effects on people induced to use those products because of the endorsement. Meanwhile, common risks of prescription drug and dietary supplement use range from minor digestive problems to serious cardiac events. (6) Celebrity endorsements require closer scrutiny especially because individuals react differently to these products, and stronger regulations should be in place to ensure consumers are not being misled.

While the FDA has sole jurisdiction over prescription drugs, it shares jurisdiction with the FTC over advertising for all products other than prescription drugs. (7) The agencies typically regulate only via guidelines published by one or both agencies, because they are reluctant to pass binding regulations. (8) This process is best suited for regulating marketing because the landscape is constantly changing.

This Note seeks to lay out the foundation for celebrity endorsements of prescription drugs with a specific focus on social media, with a brief discussion of the different issues that arise with regard to dietary supplements. It will then discuss the legal underpinnings of advertising, including the relevant statutes, case law, regulations and guidance, and a brief discussion of constitutional challenges to agency enforcement action. Finally, it will discuss the pros and cons of the current regulatory framework, and whether a better solution exists in the form of increased regulation of the pharmaceutical industry with regards to celebrity endorsements.

II. HISTORY OF DTC ADVERTISING IN THE UNITED STATES

Direct-to-consumer advertising was unheard of in the United States until the early 1980s. (9) Until then, advertisements were directed at the physicians who were prescribing the medications. (10) In 1982, the pharmaceutical manufacturers Merck and Dohme marketed their pneumonia vaccine directly to senior citizens after research showed older populations of people were not utilizing the drug in high quantities. (11) Other companies, such as Eli Lilly, followed suit and began running radio and television ads for their products. (12)

In response to the sudden surge of direct-to-consumer advertising (DTCA), the FDA imposed a moratorium on September 2, 1983. (13) The purpose of revoking and delaying further DTCA was to give the Agency more time to investigate the risks and benefits associated with such marketing strategies. Following dialogues between the FDA and pharmaceutical companies, medical providers, and consumers on the issue of DTCA, the Agency lifted the moratorium two years later, (14) concluding that existing regulations provided "sufficient safeguards to protect consumers." (15) The FDA's blessing of DTCA provided the fodder for such advertising strategies to become a major part of pharmaceutical company operation today.

A. THE RISING POPULARITY OF CELEBRITY ENDORSERS

Companies from all industries enlist celebrities to endorse their products to increase awareness of the company and its products, which stimulate consumers' interest in purchasing them. One of the first prescription drug celebrity marketing campaigns was Mickey Mantle's pitch for an arthritis medication in the mid-1980s. (16) The novel use of a celebrity to promote a specific drug, in addition to a drug company's general marketing of the pharmaceutical, caught the FDA's attention. The Agency voiced concerns that the advertisements were misleading because the public was unaware that Mantle was being paid by the pharmaceutical company Ciba-Geigy Corp. to make product claims about the drug. (17) "[C]onsumers assume the celebrities are providing objective unpaid endorsements when in fact they are hired to do so." (18) Instead of disclosing Mantle's financial arrangement with the pharmaceutical company, Ciba-Geigy Corp. pulled Mantle from its promotional ads. (19)

The FDA often cited celebrity-endorsed drug advertisements as deceptive because risks and benefits were generally not adequately discussed. (20) The use of celebrities in this manner has been termed "masked-celebrity messages" due to the fact that celebrities are "masking" their association with the manufacturer of the product, which in turn lures consumers into thinking the celebrity is an objective supporter of a product, rather than being paid to make such statements. (21) The question raised before introducing the DTC advertising moratorium thus remains relevant: Are consumers sufficiently protected if consumers are unable to reasonably make a determination whether a celebrity is being paid to voice his or her opinions?

Even more problematic than nondisclosure of celebrity financial arrangements for promotions of drugs is the enormous (and controversial) amount of money spent on advertising the drugs in general. Celebrities currently receive massive profits for advertising drugs--a celebrity endorser can reportedly make between $20,000 and $2 million for prescription drugs endorsements. (22) Another financial layer to be aware of is that pharmaceutical manufacturers are using celebrities to promote brand name drugs, rather than the exponentially cheaper generic. (23) A later discussion will reveal why these facts cannot be ignored. (24)

In many, if not most cases, the public is unaware of the financial aspect of any deal between the celebrity and the pharmaceutical company. (25) This assumes the public understands that the celebrities endorsing drug products even have deals with the companies. (26) The FDA's concerns in the mid-1980s leading to the moratorium on celebrity drug endorsements were thus not unfounded, and continue to be relevant to this day. The FDA has not promulgated any regulations requiring disclosures of financial relationships between pharmaceutical manufacturers and celebrity promoters. Additionally, the guidelines in effect lack substance.

B. CELEBRITIES AND DIETARY SUPPLEMENTS

Celebrities are also inundating the public with endorsements of dietary supplements, which are more loosely regulated than prescription drugs. (27) The dietary supplement industry is very much a "buyer-beware" world. (28) A small 2012 study by Consumer Reports found that most celebrities were hesitant to disclose whether they actually used the product they were endorsing (a requirement of the FTC regulations) (29) and how much they were being paid to endorse it. (30) Two of the six celebrities interviewed for the study, both of whom are athletes, confirmed they do use the products they endorse. (31) Of the two compensation arrangements, one athlete made $1.55 million over three years to endorse a bodybuilding supplement, while the other received $150,000 over an unknown amount of time, and received company stock of unknown value in addition. (32) As evidenced by the rapper 50 Cent's experience with receiving compensation in the form of company stock, that stock can become surprisingly lucrative. (33) Regardless of whether celebrities are endorsing prescription drugs or dietary supplements, a tremendous amount of money is exchanged.

Over half of the U.S. population uses at least one dietary supplement. (34) Studies also show that at least 23,000 emergency room visits in the United States each year can be traced back to the use of dietary supplements. (35) Complaints included heart palpitations, chest pain, and difficulty swallowing. (36) The problem with dietary supplements is even worse than with prescription drugs because the products can be obtained over-the-counter without a doctor's approval. Thus, the risks associated with ingesting a dietary supplement because a consumer saw a celebrity promoting it in a television or Internet advertisement compounds the problems discussed previously regarding celebrity endorsements of drugs. (37)

In 2014, television host Dr. Mehmet Oz was questioned in a Congressional hearing about his promotion of weight loss supplements on his TV show. (38) One such product Dr. Oz boasted in his television segment was Green Coffee Beans, which he touted as "the magic weight loss cure for every body type." (39) The FTC sued the manufacturer of Green Coffee Beans for unfair and deceptive practices, using Dr. Oz's promotion of the product as some evidence supporting its claim. (40) Oz was also chastised by Congress for his support of the "revolutionary fat buster" Garcinia cambogia, which was not proven to aid in weight loss any more than a placebo did. (41)

Kim, Khloe and Kourtney Kardashian also found themselves in hot water following their marketing campaign for the weight loss product QuickTrim. The sisters were sued in conjunction with the QuickTrim manufacturer alleging the advertising claims were "false, misleading, and unsubstantiated." (42) The claims lacked scientific evidence to prove efficacy, and the cleansing products could even be harmful because studies show side effects range from mild cramps to kidney failure. (43) Side effects of dietary can be similar to, and even worse than those associated with prescription drugs. Additionally, consumers run even greater risks due to the fact that most people do not seek a doctor's advice or supervision when taking dietary supplements. This is because consumers are under a false assumption that the products are safer than prescriptions drugs precisely because they don't require a prescription by a physician. The FTC should be extra-vigilant in its monitoring of dietary supplements for all of the above-stated reasons.

III. LEGAL RULES

The legal rules and regulations applying to prescription drug and dietary supplement advertising are complex, as the FDA and FTC enjoy joint jurisdiction over the topic through a formal interagency agreement. In 1971, the agencies entered into a Memorandum of Understanding, which defined the roles of each agency in working toward the common goal of protecting the consumer. …

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