The Issue of Prescription Drugs: Adverting and Regulation
Have you ever watched a commercial or read a magazine advertisement for a medication? These advertisements provide claims that the product is the most effective on the market. They also provide positive and negative effects of taking the drug. Most even have amazing graphics of retired couples walking the beach with big smiles on their faces. In our country there are strong debates on the ethics and legal regulation for these same advertisements. Industry professionals call this form of advertisement, direct-to-consumer pharmaceutical advertising. Direct-to-consumer pharmaceutical advertising can inform the public on the positive and negative effects of medication for specific health conditions and health decision. In order for pharmaceutical advertising to improve medical condition awareness, increase corporate profits, and remain creditable, federal government regulations must be enforced.
There are three significant types of direct-to- consumer pharmaceutical advertisements that help consumers learn about heath conditions and make educated health decisions. One type is the "help-seeking ad," which provides only information about a medical condition and encourages patients to contact their physician but doesn't mention a product (Ventola). For instance an advertisement may describe symptoms of hearth burn being difficult swallowing, persistent sore throat, or stomach pain in the upper abdominal. The advertisements does not state a specific drug name but only encourages people to consult their doctor if they feel they have any of these symptoms. Another category is the "reminder ad," which includes the product name; this type may provide information about strength, dosage form, or price, but it doesn't mention the indication or make any claims (Ventola). These types of advertisement sales driven and do not provide any additional details or claims about how well the medication works. For instance a sleep aide may remind the audience of the product name and provide a catch phrase of sleep easy. The third and most common type is the "product claim ad," which mentions the product and its indication and includes efficacy or safety claims (Ventola). These advertisements provide the audience a balance overview for the good and the bad claims of the medication. These types of advertisements rely heavily on how the information is presented and often reflect the company's opinion through a graphic image. Each of these types of direct-to-consumer advertisement are assembled and presented to the audience in the most effective media channels.
Direct-to-consumer pharmaceutical advertising is presented through a variety of media channels. These direct-to-consumer advertisements (DTCA) are disseminated via television and radio, magazines and newspapers, and-increasingly-the Internet (Wang). These types of advertisements are designed directly for the consumer audience. The use of media channels to advertise pharmaceutical medications can be viewed both positively and negatively. On one hand the ability to reach large amounts of consumers who were not aware that a specific medication is available as a solution for their therapy can benefit both the patient and the company. However these same advertisements may also influence consumer demand for medications that may not be medically necessary. One highlighted problem area for direct-to-consumer advertising has become the high-tech media space.
With the advance of the internet, smartphones, and applications there has become a resurgence in the advertising and marketing industry. High-tech media like smartphones and the growth in wireless Internet connectivity are allowing more patients to access promotional information about potentially beneficial treatments, but the lack of firm regulatory guidelines governing DTCA may lead to suboptimal treatment decisions and health and economic outcomes (Wang). These same companies use technology to optimize personal data collection, neuromarketing campaigns, and use unbranded websites to market and influence consumer prescription decisions. If you as a consumer search the internet for signs of heartburn, the next time you log online should an advertisement for Nexium automatically populate on your screen? The use of high-tech media channels generates strong ethical opinion and an even stronger need for regulation on direct-to-consumer advertising. Where is the fine line between a company trying to make a legitimate profit selling a product and the influence they have on consumers to choose their product over another? Direct-to-consumer pharmaceutical advertising has caused debate regarding the conflict of interest between social decisions to select the most appropriate medications for each condition and economic business goals.
Direct-to-consumer pharmaceutical advertising spending and prescription drug costs are at an all-time high. Last year, US giant Pfizer, the world's largest drug company by pharmaceutical revenue, made an eye-watering 42% profit margin. As one industry veteran understandably says: "I wouldn't be able to justify [those kinds of margins]" (Anderson). As a pharmaceutical company, those high margins are praised and often required to continue production. As a consumer, you question with margins that high why are medication costs still rising?
In response to the consumer pharmaceutical companies report, the process of determining a price point for a newly developed medication can be complex and hard to evaluate. Of course, each new product represents varying degrees of scientific advancement and therapeutic innovation, which makes classifying them on a product by product basis quite difficult (Dranove). Also, industry defenders counter that high prices are necessary to offset expensive and uncertain research and development, and that if profits were to fall, incentives for future innovation would suffer (Dranove). To a company this means there are more costs and expenses to develop and produce better drugs. In order to develop better medication a rise in production costs are required and an even stronger need for pharmaceutical companies to improve sales goals and profits.
The need to improve sales goals and profits have caused a push for international expansion efforts. Global growth efforts by pharmaceutical companies will generate sales, raise profits, and create a need for medical advancements. There are debatably 194 countries in the world. The only other country that permits direct-to-consumer advertising of prescription medication is New Zealand (Collier). With strong government regulation there have been major hurdles entering the global market. However, between 2015 and 2020, they are expected to account for USD 190 billion in sales growth, of which approximately 40 percent will come from innovative drugs.1 much of this growth is likely to be driven by Brazil, Russia, India, China, Mexico, and Turkey (Ascher). Global growth should be viewed as a positive. In the perspective of a pharmaceutical company, international sales growth will increase profits. As a consumer, the global growth efforts will allow pharmaceutical advertising to bring awareness of health conditions and the ability to provide aide to those who are unaware and in need of therapy. In order to achieve expansion and remain ethical, government regulations on direct-to-consumer advertising will need to be enforced.
Healthcare reform and federal regulation is the required element in maintaining creditability of direct-to-consumer pharmaceutical advertising. The government agency responsible for regulation is the United States Food and Drug Administration (FDA). More specifically, within the FDA, The Office of Prescription Drug Promotion (OPDP) is responsible for the regulation of direct-to-consumer pharmaceutical advertising through media channels. The office's mission statement, "To protect the public health by ensuring that prescription drug information is truthful, balanced, and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering better communication of labeling and promotional information to both healthcare professionals and consumers" (OPDP). They engage in a variety of tasks to perform this responsibility, including: providing written comments to pharmaceutical sponsors on proposed promotional materials to ensure clear and unambiguous communication of the laws and regulations relating to prescription drug promotion; reviewing complaints about alleged promotional violations; initiating enforcement actions on promotional materials that are false or misleading; comparing the product labeling and promotional materials of various closely related products to ensure that the regulatory requirements are consistently and equitably applied; traveling to major medical meetings and pharmaceutical conventions to monitor promotional exhibits and activities; and acting as a liaison between OPDP and other divisions within the FDA on promotional issues (OPDP). The office of Prescription Drug promotion regulates, acts, and provides programs for the public to report misleading advertisements to aide in health awareness credibility.
The government and consumers are not the only ones socially responsible to report unethical direct-to-consumer advertisements. Healthcare providers and prescribers have a duty to report misleading pharmaceutical advertisements. The "Bad Ad" Program is administered by the agency's Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research. It will help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency (OPDP). OPDP's traditional surveillance activities have been somewhat limited by its inability to observe drug promotion in settings such as physician offices, local dinner programs, and promotional speaker training sessions. By raising awareness about misleading promotion and providing an easy process for reporting it, FDA can gain the valuable assistance of health care professionals in helping to decrease the number of misleading promotional messages about prescription drugs (OPDP). Programs this provide a social obligation to regulate consumer awareness on medications and therapy. Strong government regulations and programs allow the balance our country needs to allow direct-to-consumer advertisements to remain a positive part of our economy, while still allowing pharmaceutical companies to reach economic business goals.
In order for pharmaceutical advertising to improve medical condition awareness, increase corporate profits, and remain creditable, federal government regulations must be enforced. It is also important to remember that reaching new markets through new media channels will provide positive medical condition awareness for the public. Also, understanding the value of developing, producing, and marketing a medication will help the public understand prescription drug costs. Additionally, programs like the "Bad Ad" program, which allows for social regulation will help federal regulators control misleading prescription drug promotion and further our positive knowledge of medical conditions. Through direct-to-consumer pharmaceutical advertising support, pharmaceutical companies and regulators can bring positive awareness of medical conditions and ways to treat specific conditions. There is value in understanding that corporations and consumers can both benefit from creditable medical awareness through enforced government regulations to achieve optimum consumer health decision. Direct-to-consumer pharmaceutical advertising is an industry of growth and regulation.
Work Cited
Ventola, C. Lee. "Direct-to-Consumer Pharmaceutical Advertising: Therapeutic or Toxic?" National Center for Biotechnology Information. MediMedia USA, Inc.
"The Office of Prescription Drug Promotion (OPDP)." U.S. Food and Drug Administration. U.S. Department of Health and Human Services.
Wang, Bo, and Aaron S. Kesselheim. "The Role of Direct-to-Consumer Pharmaceutical Advertising in Patient Consumerism." AMA Journal of EthicsŽ. American Medical Association, Nov. 2013.
Dranove, David, Craig Garthwaite, and Manuel Hermosilla. "PHARMACEUTICAL PROFITS AND THE SOCIAL VALUE OF INNOVATION." Northwestern University. June 2014.
Anderson, Richard. "Pharmaceutical Industry Gets High on Fat Profits." British Broadcasting Corporation. 6 Nov. 2014. Web. 14 May 2016.
Ascher, Jan. "Pharma's next Challenge." McKinsey & Company.