Direct-to-consumer advertising
Direct-to-consumer advertising refers to the marketing and advertising of pharmaceutical products directly to consumers as patients, as opposed to specifically targeting health professionals. The term is synonymous primarily with the advertising of prescription medicines via mass media platforms—most commonly on television and in magazines, but also via online platforms.
Direct-to-consumer advertising is only completely legal in New Zealand and the United States, but are subject to regulations regarding the balanced disclosure of a prescription's benefits in comparison to its risks, among other factors. Regulations regarding DTCA are typically applied to advertising materials that describe a prescription's indications and benefits, and may be more lenient to advertising materials which do not discuss uses. Many countries ban any advertising of prescription drugs directly to consumers.
There are ethical and regulatory concerns regarding DTCA, specifically the extent to which these ads may unduly influence the prescribing of the prescriptions based on consumer demands when, in some cases, they may not be medically necessary, or there are cheaper options available. Critics of DTCA have argued that too much is spent on marketing medications, rather than into research and development; in the United States, ad spending by drugmakers reached US$5.2 billion in 2016.
As outlined by Science Daily in 2009, the impact of DTC media on technology-assisted health behaviors is demonstrated by the increasing number of consumers making critical medical decisions informed primarily by online health information.
Types
The U.S. Food and Drug Administration defines several common types of DTCA for prescription medication:- A "product claim" advertisement identifies the nonproprietary and trade names of the medication, and contains at least one approved indication, and claims surrounding its benefits. They contain a call to action urging viewers to ask their doctor or seek an external resource for more information.
- A "reminder" advertisement is designed to build brand recognition for a medication. Reminder ads do contain a call to action, but exclude any information or imagery that pertain to the medication's approved use. They may have themes that vaguely allude to the drug's purpose, such as a commercial for the erectile dysfunction medication Viagra that featured scenes of a man happily walking to work to the showtune "Good Morning", emphasizing an innuendo in the lyric "it's great to stay up late".
- A "help-seeking" advertisement is presented as an awareness campaign for a particular medical condition. They do not specify any specific product or treatment themselves, but their call to action direct the viewer to resources that promote a specific prescription option for the condition. Help-seeking campaigns are sometimes used as preliminary marketing for new drugs.
Support
Supporters of direct-to-consumer advertising argue that advertisements increase competition which leads to lower prescription drug prices and new development, citing, for instance, that between 1997 and 2001, spending on research and development in the U.S. increased 59% while spending on promoting drugs directly to patients increased 145%. However, other experts have asserted that funding for R&D is determined by several other factors. Direct-to-consumer advertising, among other patient education initiatives, can educate consumers and patients about new treatments and therapeutic options that may not have been proactively mentioned by their healthcare professional. Proponents of DTCA claim this provides a vital opportunity for the public to be aware of what is available to them and to engage in an educated discussion with their doctor. A study observed that direct-to-consumer advertising promotes communication between patients and their doctors about medications. Thirty percent of Americans indicated they talk with their doctor about a medicine they saw on TV. In addition, surveys showed that increased advertising has had a positive impact on the degree to which people adhere to a given course of treatment – but only among those who were already on medication prior to exposure to direct-to-consumer advertising. Among this population, a 10% increase in exposure to drug advertising increases the rate of adherence between 1% and 2%.Market impact
It has been argued that direct-to-consumer advertising can influence the doctor–patient relationship, including patients bringing up their need for an advertised, name-brand drug as their primary concern during a doctor visit, and becoming interested in newly-introduced medications that may not have undergone sufficient postmarketing surveillance. It has been demonstrated that direct-to-consumer ads have contributed to the frequency of requests made by patients towards their physicians to prescribe analgesic drugs, including opioids. A patient's request for a specific medication dramatically increases the rate at which physicians prescribe usually more expensive, branded drugs even when treatment for existing indications does not warrant such use. Pharmaceutical companies have also faced allegations of "disease mongering"—the process of promoting awareness of minor conditions such as balding and skin wrinkles in such a way that it encourages the sale of treatments for them.Drug safety
Advertisements generally begin within a year of drugs entering the market, before postmarketing surveillance is available to see if adverse effects emerge, which increases the risk of harm. In the early 2000s, the FDA's resources to screen DTC ads were not keeping pace with the number of ads being produced, raising the risk that the inappropriate ads were not removed. Vioxx was heavily marketed and was widely-prescribed after its approval in 1999. When the drug was withdrawn for safety reasons in 2004, Merck, its developer, and the FDA were criticized for the campaign.Direct-to-consumer advertising of pharmaceuticals had long been suspected of downplaying the risk to consumers. Studies by Scientific American reliably found that consumers perceived the side effects of drugs to be less severe when they were presented with ads that listed both "major" and "minor" side effects, and more severe when only major side effects are listed.
Several DTC ads have faced criticism or FDA warnings over containing depictions of activities that are part of a prescription's contraindications, such as an advertisement for the blood thinner Xarelto which featured scenes of a patient spokesperson among motorcycles, and a print ad for the Factor IX treatment Idelvion containing an image of a soccer player.
Criticism
Some studies have asserted that direct-to-consumer advertising misleads patients into demanding heavily-advertised drugs, leading to superfluous or sub-optimal treatment. Doctors may feel pressured to prescribe specific brand-name medications because they were mentioned by a patient. In 2016, the Centers for Disease Control and Prevention reported that 47% of all antibiotics prescribed in the United States were unnecessary. Another study of young people living in West Palm Beach, Florida found that a 10% increase in advertising expose increased the total number of prescriptions by 5%; a higher percentage change than in Denver, Colorado – where DTCA expenditures per person are lower.Critics also argue that resources spent on advertising could otherwise be spent on research and development for new drugs and medical therapies. Danish physician Peter C. Gøtzsche indicated that pharmaceutical companies will advertise for their most profitable products, many of which are unnecessary "me-too" drugs. He maintains that "there is no need for marketing, as the products should speak for themselves."
Some drug ads have "gendered" diseases in ways that do not reflect actual epidemiology. Women's bodies have also been objectified to mask or distract from unpleasant aspects of diseases. The marketing of drugs for inflammatory bowel disease have been called out on both counts. Similarly, the marketing of Gardasil was primarily aimed at young women, when sexually transmitted diseases are carried by, and affect, both genders.
Parodies
U.S. DTC regulations have led to drug commercials having formulaic elements that have often been parodied in popular culture, such as the juxtaposition of often-lighthearted footage with the mandated reading of side effects. The long-running variety show Saturday Night Live has featured sketches with parody commercials for drugs, many of which featuring exaggerated side effects or inane purposes. The Adult Swim short Unedited Footage of a Bear similarly portrays a stereotypical commercial for the fictitious medication Claridryl, but slowly segues into a psychological horror short film involving the woman portrayed in the ad.By region
Brazil
In 2008 a new resolution from ANVISA, Resolution 96 from December 17 was released, with focus on medication advertisements. It allows direct-to-consumer advertising of non-prescription medication, with restrictions on the type of drug and words and images that can be used, among other things. Advertisements for prescription medications can only appear in scientific, medical, or health professional journals.Canada
The Food and Drugs Act prohibits most direct-to-consumer advertising of prescription medications: all direct-to-consumer advertising of drugs was forbidden until 1978, when Health Canada began to allow ads containing names, quantities, and prices only, so that pharmacies could display their prices for comparison purposes. In 2000, Health Canada adopted an interpretation of this law allowing for the aforementioned "reminder" and "help-seeking" advertisements, although U.S.-style "full product ads" that mention the purpose of a prescription remain prohibited. Later that year, Health Canada ruled that a pairing of similarly-themed reminder and help-seeking commercials ran afoul of the regulations, as their combination constituted a full product ad.There are no regulations requiring direct-to-consumer advertising to be removed or substituted from U.S. television channels and publications when they are being distributed in Canada.
In 2014, York University professor and physician Dr. Joel Lexchin, and University of British Columbia associate professor Barbara Mintzes, published a study that highlighted 10 DTC cases between 2000 and 2011 with "unsatisfactory" responses from Health Canada. They found that Health Canada's application of these regulations " accountability and transparency"—with no public record of complaints and enforcement besides media coverage of certain prominent cases, and no evidence that Health Canada has ever issued fines for violations. In conclusion, they stated that "since DTCA became prominent in the U.S. in the mid-1990s, successive governments of different political stripes in Canada have shown a remarkably consistent commitment to non-enforcement".