Pharmaceuticals Advertising: Overview
Pharmaceutical advertising plays a significant role in the healthcare landscape, particularly in the United States and New Zealand, which are the only countries that allow direct-to-consumer (DTC) advertising for prescription drugs. This form of advertising accounts for a substantial portion of pharmaceutical companies' budgets, often outpacing their research expenditures. DTC advertising aims to educate consumers about medical conditions and available treatments, yet it has sparked considerable debate. Critics argue that it can lead to unnecessary anxiety, increase healthcare costs, and mislead patients about medications, while proponents believe it empowers individuals to engage in their healthcare decisions.
Historically, the landscape of pharmaceutical advertising has evolved from unregulated patent medicines in the late 19th century to today's more structured and regulated environment. Regulatory bodies like the FDA oversee advertising practices to ensure compliance and safety. Despite these regulations, challenges persist, including understaffing and the effectiveness of enforcement actions against misleading advertisements. The industry continues to face scrutiny for practices such as using celebrity endorsements and the potential for conflicts of interest, further complicating the public's trust in pharmaceutical advertisements. Today, the financial stakes remain high, as billions are spent annually to promote medications, reflecting the ongoing tension between commercial interests and public health.
Pharmaceuticals Advertising: Overview
Introduction
A visit to the doctor’s office would not be complete without encountering some form of advertising or receiving a free sample of a prescription drug. Advertising is a big component of the pharmaceutical industry, accounting for about 20 to 30 percent of companies’ annual budgets and often exceeding their research budgets. The scope of advertising is broad, with companies advertising in magazines, on radio and television, and in the offices of doctors and pharmacists.
Much of the debate over pharmaceutical advertising is regarding direct-to-consumer (DTC) advertising. The only countries that allow DTC advertising are New Zealand and the United States. Opponents claim that DTC advertising wastes time and money by overloading physicians with patient concerns created by pharmaceutical industry advertisements, causing patient anxiety about medical issues that may not be relevant. They argue that DTC can be misleading and ultimately increases health-care costs by adding frivolous expenses to the system. Proponents of DTC argue that these efforts educate patients on the symptoms and solutions for common diseases and may improve patient health in the long term, thus decreasing the overall need for treatment of disease at an advanced stage, which tends to be more difficult and much more expensive.
Understanding the Discussion
Direct-to-Consumer (DTC): The use of advertising, mostly by the pharmaceutical industry, to market drugs directly to consumers through media outlets such as magazines, television, radio, and the Internet.
Disease Awareness Ad: An ad designed to increase the number of consumers interested in buying a drug by educating them about its uses and the prevalence of the disease it treats.
Key Opinion Leaders: Well-respected medical professionals known to have an influence on physicians. These professionals are recruited by pharmaceutical companies to spread the word about a drug and assist with marketing.
Reminder Ad: A drug advertisement that mentions the name of the drug being advertised but not the symptoms or diseases it treats. Reminder ads are exempt from advertisement regulations and do not require any disclosure of information to consumers.
History
Prior to the twentieth century, the pharmaceutical industry, such as it was, consisted of manufacturers of so-called patent medicines: medical elixirs that claimed to heal anything and were freely advertised on billboards and in stores and newspapers. Patent medicines were not regulated for consistency or safety and were primarily bought by uneducated consumers with limited access to doctors. The diseases these medicines claimed to cure ranged from jaundice to kidney disease. For instance, Ayer’s Sarsaparilla was touted as a cure for tired feelings; stomach, kidney, and liver disorders; jaundice; and dropsy (edema). It was, in fact, sweetened, flavored water not much different from modern-day root beer.
Many patent medicines had an alcohol content as high as 50 percent, at least five times the amount in most beers and wines, and many contained dangerous ingredients such as mercury, borax, salicylic acid, and formaldehyde—chemicals now used to kill pests and preserve bodies. Eventually, in the late 1800s, the media began to investigate patent-medicine companies. Samuel Hopkins Adams, a well-known investigative journalist, wrote a series of articles called “The Great American Fraud,” published in Collier’s Weekly in 1905. As a result, a prominent chemist at the United States Department of Agriculture (USDA), Harvey Wiley, called for Congress to regulate this type of “medicine.” Congress passed the Pure Food and Drug Act of 1906, which required all drugs to have their active ingredients listed on the packaging and established a minimum standard of purity for certain drugs.
In 1927, the Food and Drug Administration (FDA) was created to oversee safety and production. It began regulating pharmaceutical advertising in 1962. In the 1980s and 1990s, the focus of advertising shifted from doctors to pharmacists, when pharmaceutical companies realized that pharmacists were able, and likely, to recommend that customers buy cheaper generic rather than brand-name prescription drugs. The companies wanted their names and products to be known to pharmacists, who had increasingly more influence on consumer decisionmaking.
In the mid-1980s, Pfizer and Merrell Dow pioneered DTC advertising. These two companies drove consumers to their physicians by suggesting that doctors had new treatments for a number of health issues, including smoking. They created vague ads that did not mention a brand name, instead simply describing symptoms and advising patients to visit their doctor if they showed any signs of these symptoms.
In an effort to curb overuse of prescription drugs, the FDA placed a hold on drugs ads in 1983 and, in 1985, began requiring drug companies to list all side effects in their ads. These regulations inspired an era of “reminder ads,” which showed positive images of people who were taking the drug without mentioning the specific condition it treated. The codification of more relaxed guidelines in 1997 led to an abrupt increase in the amount of money spent by the pharmaceutical industry on DTC ads, from $985 million in 1996 to a high of $5.4 billion in 2006.
Advertising became such an integral part of the pharmaceutical industry that departments were formed to include representatives who would market directly to physicians and pharmacists. These representatives educate health-care professionals on the use of the drug, as well as side effects and dosages. Representatives also provide samples to doctors for patient distribution.
The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require that television advertisements be submitted for review no later than forty-five days before they are broadcast to the public. The FDA’s internal guidelines specify the types of ads, including the first ad for a new prescription drug and any ad for a schedule II controlled substance, that must be submitted for preapproval. All other television ads are subject to review upon first broadcast. Ads that make specific claims about a drug must at minimum include the drug’s generic name, at least one approved use, and all associated risks, including any side effects. If the ad violates regulations, warning letters are sent by the FDA, which may lead to a slap on the wrist or more severe measures.
The enforcement of DTC regulations remains difficult due to understaffing, and warning letters to stop illegal advertising can sometimes be ineffective. In one case, the warning letters issued by the FDA over the period of a year were not given to the pharmaceutical companies until eight months after the ads were first broadcast. Most of the ads were short lived and had already been replaced with new ads by the time the letters reached the companies. Slowing the process further, a 2002 change in FDA regulations required more staff members to review the advertisements and regulatory letters before the letters were sent.
Many critics believe that DTC ads are confusing and misleading. An FDA survey of doctors in 2002 found that almost half thought that patients were misled by pharmaceutical advertising, and almost a quarter of these doctors felt that patients pressured them into prescribing specific drugs. The FDA argued that the ads did not give enough information about the circumstances in which a drug should be used or alternatives to taking the drug, such as changes in diet or exercise.
In 2008, the US House Committee on Energy and Commerce investigated the use of celebrities in television advertisements for drugs. The investigation stemmed from an ad released by Pfizer for its cholesterol-lowering drug Lipitor. In the ad, Dr. Robert Jarvik, who helped develop the first successful artificial heart, referred to himself as a doctor; while he did obtain a medical degree, he was not a cardiologist and had never been licensed to practice medicine. In addition, scenes of Jarvik rowing in a lake, presumably demonstrating his fitness after taking Lipitor, proved to have been shot with a stunt double, and it was later revealed that he had not started taking the drug until several months after filming began. The controversy led Pfizer to pull all ads featuring Jarvik.
In response to these and other criticisms of DTC advertising, Pharmaceutical Research and Manufacturers of America (PhRMA) established its own guidelines for pharmaceutical advertising, originally published in 2005 and updated in 2009 following the Jarvik controversy. Among other things, these eighteen guiding principles state that advertisements should educate consumers about the drug and the condition it treats, that actors portraying doctors should be identified as such, that ads featuring genuine doctors should disclose if they are receiving compensation for their appearance, and that celebrity endorsements should accurately reflect the celebrity’s experience and opinions.
Pharmaceutical Advertising Today
By 2023, the only countries to allow DTC prescription drug advertising were the United States and New Zealand. According to the USC Leonard D. Schaeffer Center for Health Policy and Economics and the biopharmaceutical news site Fierce Pharma, pharmaceutical companies in the US had spent a total of $6.58 billion on advertising in 2020. AbbVie, Sanofi and Regeneron, Pfizer, Novo Nordisk, Eli Lilly, Bristol-Myers Squibb, and Amgen were the pharmaceutical companies that spent the most on advertising that year.
A group of state attorneys general sued the advertising and marketing firm Publicis Health as well as the consulting firm McKinsey and Company, for their roles in promoting Purdue Pharma's opioid painkiller OxyContin with a marketing campaign that targeted prescribers between 2010 and 2019, a time when hundreds of thousands of Americans had died of opioid overdoses. By 2024, McKinsey had paid out about $1 billion in settlements, and that year Publicis became the first marketing company to settle a lawsuit for falsely promoting drug involved in the opioid crisis. The $350 million settlement was intended to help affected communities in New York, Colorado and other states address the opioid crisis. The settlement also banned Publicis from working on opioid marketing and sales campaigns and required the company to release internal documents related to its past work promoting opioid drugs.
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