Direct to Consumer Advertising

Direct to Consumer Advertising (Adopted 2004, amended 2009, 2014) Executive Summary of Policy Contained in this Paper Summaries will lack rationale and background information and may lose nuance of policy. You are highly encouraged to read the entire paper. 

The AAPA believes that Direct to Consumer Advertising (DTCA) presented in a responsible and ethical manner may be of some value to patients. Such information should be scientifically substantiated, accurately presented, and free of bias and false or misleading claims.

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AAPA urges that any DTCA by pharmaceutical companies be based on disease state only, without mention of a specific drug by name or category of drug, and that patients should always be urged to see their health care professional before taking prescription medications.

Introduction Direct-to-consumer advertising (DTCA) is the promotion directly to potential patients of prescription drugs through newspaper, magazine, television and internet marketing. Drug companies also produce a range of other materials that are available in medical offices or designed to be given to patients by medical professionals or via patient groups. The only two developed countries where DTCA is currently legal are the U.S. and New Zealand. While banned elsewhere, the drug industry has repeatedly mounted major lobbying campaigns to have DTCA allowed in Europe and Canada. While there is oversight of pharmaceutical marketing in the developed world, there are few provisions for monitoring DTCA in low and middle income countries, where it remains illegal. Furthermore, the use of social media platforms and advertising through the internet circumvents national boundaries and has resulted in largely unchecked global DTCA by both legitimate and illegitimate pharmaceutical companies. The federal Food and Drug Administration (FDA) regulates the promotion and advertising of prescription drugs in the United States, including DTCA and materials directed to medical professionals, to ensure that they are not false or misleading and otherwise comply with applicable laws and regulations. [see 21 U.S.C. § 352(n), 21 C.F.R. § 202.1 (2013)]. FDA regulations require that drug companies submit final advertising materials to the FDA at the time they are first disseminated to the public. In addition,

drug companies may voluntarily submit draft versions of DTC advertising materials to FDA prior to their release in order to obtain advisory comments from the agency. FDA’s authority does not extend to “helpseeking” advertisements – those that do not identify prescription drugs by name, but rather discuss a disease or condition and advise the audience to “see your doctor” for possible treatments. In 1997 the FDA relaxed regulations on broadcast media advertising of prescription drugs by stating that adequate provision of risks and benefits could be communicated by simply referencing a toll free number or website. Annual spending on DTCA promptly tripled to $1.3 billion dollars and reached $4.3 billion by 2010. The fastest growing aspect of drug marketing, DTCA has outpaced marketing directly to providers, and drug research and development. The majority of spending is now on television advertising with viewers exposed to nine commercials per day for prescription drugs. As spending increased, so did the number of regulatory letters sent by the FDA to pharmaceutical companies concerning false or misleading DTCA. The Pros and Cons of DTCA The pharmaceutical industry argues that DTCA advertising helps educate consumers of potential conditions and encourages them to see their health care professional for diagnosis and treatment. While acknowledging that DTCA increases the amount spent on prescription drugs, they argue that in the long run early treatment and diagnosis reduces spending on other medical services, such as hospitalization. Critics of DTCA argue that the industry's advertising is primarily emotional in style and understates the adverse side-effects and as such is misleading. The imagery of the ads is appealing while the potentially serious side effects are buried in the fine print. They also argue that the claimed health benefits are overstated. Surveys reveal that people who have seen DTCA ads will often request and be prescribed the drug. DTCA campaigns will usually aim to have pre-primed prescribers via a closely linked parallel promotional campaign. Critics argue that this results in over-diagnosis of conditions and inappropriate use of prescription drugs, even where non-drug treatments are as effective or more effective. As a result, they say, DTCA unnecessarily drives up the overall cost of healthcare without necessarily improving the health of those treated.

Problems with DTCA of pharmaceuticals may have significant unintended consequences. These include but are not limited to patients that seek medications from pharmacies on the Internet and outside the United States without a prescription or without prescriber monitoring or even awareness of medications. Patients may not be aware of the entire spectrum of other more appropriate and less expensive therapeutic options than the advertised drug. Side effects are often not communicated in a comprehensive manner in advertising or marketing communications. Furthermore, every drug has risks and benefits, and patients are often unaware of drug-drug, drug-herb, drug-supplement, or drug-food interactions. Health care professional monitoring ensures that pharmaceuticals are appropriate for a patient’s particular health condition and that the benefit outweighs any risk. A November 2006 report by the U.S. Government Accountability Office report noted that "studies we reviewed found that increases in DTC advertising have contributed to overall increases in spending on both the advertised drug itself and on other drugs that treat the same conditions. For example, one study of 64 drugs found a median increase in sales of $2.20 for every $1 spent on DTC advertising. Consumer surveys suggest that DTC advertising increases utilization of drugs by prompting some consumers to request the advertised drugs from their physicians, who studies find are generally responsive to these requests. The surveys we reviewed found that between 2 and 7 percent of consumers who saw DTC advertising requested and ultimately received a prescription for the advertised drug." [http://www.gao.gov/htext/d0754.html accessed March 8, 2014] Conclusion The American Academy of Physician Assistants (AAPA) believes Direct to Consumer Advertising (DTCA) that is presented in a responsible and ethical manner may be of some value to patients. Such information should be scientifically substantiated, accurately presented, and free of bias and false or misleading claims. DTCA and marketing of pharmaceuticals, devices, or surgical procedures may create significant patient safety concerns if it leads patients to seek health care solutions without consulting with a health care professional, increases costs of care, or inappropriately directs patients or providers away from best-practice solutions or evidence-based medicine. As such, AAPA urges that any DTCA by pharmaceutical companies be based on disease state only, without mention of a specific drug by name or

category of drug, and that patients should always be urged to see their health care professional before taking prescription medications.

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