Direct-to-Consumer Advertising Essay

Direct-to-consumer (DTC) advertising of prescription drugs has become common place in today’s society. Every household with a television is aware of DTC advertising as they interrupt their nightly programs. Every national magazine or local newspaper offers advertising on the latest drug remedy for what ails us. This multi-media approach is relatively new for pharmaceutical companies as previously such efforts were directed only at physicians who were the sole decision makers when choosing medications. With the 1997 change in the Food and Drug Administration’s (FDA) guidelines along with patients desires to be more involved in their own care and treatment, drug companies have expanded their promotional efforts to include the consumer. This essay will look at some of the current regulations concerning DTC advertising, pros and cons of these ads, and the ethical issues that arise from DTC advertising. Regulations Direct-to-consumer (DTC) advertising is the â€Å"promotion of prescription drugs through newspaper, magazine, television and internet marketing.† (Direct-to-consumer advertising, 2010) These ads are directed towards the end user, the consumer, and not the prescriber/physician. Prescription drug advertising has been regulated by the U.S. Food and Drug Administration (FDA) since 1962. Their Division of Drug Marketing, Advertising, and Communications (DDMAC) is responsible for ensuring that companies that directly advertise to the public are providing â€Å"information that is truthful, balanced, and accurately described.† (FDA, 2010) Even though the FDA has oversight on DTC advertising, it should not impose unnecessary restrictions on them as they fall under the category of commercial speech protected by the first amendment (Evans & Friede, 2003, p. 387). The Federal Food, Drug and Cosmetic Act requires that anyone who makes, packages, or sells prescription drugs for hum ans must disclose information in their advertisements about the products uses and risks (U.S. Department of HHS, 1999, p. 3). This information disclosure is called the brief summary. Contrary to its name, the brief summary is rather lengthy as it must contain every risk associated with the drug’s approved use. Prior to regulatory changes made in 1997, these disclosures had to be included in every advertisement making television commercials impractical due to the restricted amount of time available. Now there is a distinction between print and broadcast advertising so that only print ads must contain this brief summary. The DDMAC’s 1997 revisions now only require audio and/or visual ads to disclose two things. The drugs major risks in consumer-friendly language, the major statement, and give adequate provision for the consumer to access the full product labeling (U.S. Department of HHS, 1999, p. 5). This can be achieved by providing a toll free number to call, referencing the full advertisement in a print ad, or making sure brochures are easily accessible outside of a physician’s office, like a pharmacy or grocery store. By decreasing the amount of information required in these ads, commercials suddenly became a viable form of marketing. Advertisements seen on television or in magazines are not required to be submitted to the FDA for approval prior to their release; however, companies must submit their ads to the FDA when they first appear in public. The FDA is available to offer their advice to pharmaceutical companies when asked for help (FDA, 2010). Once they see the ad and if they feel that it violates the law, they will send a warning letter requesting that the company stop the ad immediately. These letters are posted on their web site for public inspection. The drawback to this process is that an ad that violates the law may be aired without oversight. If the warning letters do not rectify the situation, â€Å"the FDA can work with the Department of Justice to seek injunctions against companies, or criminally prosecute firms.† (Vogt, 2005, p. 26) The FDA also has the authority to seize drugs that it deems as misbranded and can even reverse approval for the drug. Pros There are numerous arguments on the benefits of direct-to-consumer advertising. Supporters of DTC advertising contend that ads can be educational, provide important health information, and generate sales to further necessary research and development (R&D). One of the most commonly heard reasons is that DTC advertising has assisted consumers in â€Å"identify(ing) disease conditions and engage(ing) in more informed conversations with their health care providers.† (Pfizer, 2011) Supporters uphold that this advertising helps the doctor/patient relationship by being a conversation starter allowing discussions on disorders and options that a patient may not have known how to talk about earlier. Most patients today are educated and desire a greater level of involvement in their healthcare choices. DTC advertising gives the consumer power through knowledge. Important health information can be delivered in DTC advertising. These ads have the ability to reach millions of consumers rela tively easily. Through print and media advertising, pharmaceutical companies can play a useful role in raising awareness of certain conditions and disorders. Raising the public’s awareness can promote consumers to seek medical attention when they otherwise may not have. Seeing these conditions on television or in a magazine can lessen the stigma associated with them. Large pharmaceutical companies use the money made from DTC advertising to fund their R&D. This research and development plays an integral part in ensuring a drugs safety which in turn saves generic companies from needing to repeat R&D on the same drug. This makes generic manufacturers another supporter of DTC ads. By advertising new, name brand drugs, companies are causing a demand for the medication. Once the drug has lost its patent, physicians can begin prescribing the less expensive generic alternative. The generic manufacturer has benefited by default on the large pharma’s campaign. Cons There are an equal number of allegations on the negative effect of direct-to-consumer advertising. Opponents of DTC ads argue that ads can be detrimental to the physician/patient relationship, increase medication costs, and harm public health. Those against DTC ads feel that they have the potential to change the way doctors and patients interact with each other. A patient may see a particular advertisement and be convinced that they have a certain condition or that they need a specific drug. The patient may then present to their doctor feeling that they have diagnosed themselves and request prescriptions even if not needed. The physician may then feel pressured to oblige the patient rather than discussing other, possibly cheaper or drug free, treatment options. This scenario can lead to over-prescribing and over-use of a particular drug based on the effectiveness of the advertisement. Others have argued that advertising is expensive and the pharmaceutical companies have to recoup the ir cost somewhere. This leads to the cost being passed on to the consumer in the form of higher prescription costs. The amount of money spent on DTC ads has increase dramatically from 1997 to 2005 from $1.1 billion to $4.2 billion (GAO, 2006, p. 12). This increase expenditure could create higher healthcare costs across the board. Another cost of DTC advertising could be at the expense of public health. Most consumers lack the specialized knowledge required to evaluate the content of these ads and therefore take them at face value. They may not be fully aware of the harmful side effects or interactions of the drug. DTC ads can be seen as misleading since they are not required to mention other alternatives like diet, exercise or other preventative measures. These alternatives could treat the advertised condition without medication. By not including the alternatives, companies are advocating drug use as a primary response to medical conditions. Ethical Issues Pharmaceutical companies have a substantial obligation to ensure that their direct-to-consumer advertising is ethical. Their products not only have the ability to help consumers but they may also cause potential harm. Advertising of a drug is not like advertising of any other product where you are trying to convince the consumer to buy something they don’t need. Drug advertising needs to educate the consumer while still promoting their product. Persuasion tactics therefore should be ethical. How does one go about knowing if DTC advertising methods are ethical? In the book Persuasion: Theory and Practice, ethical persuasion is defined as â€Å"a communication activity that †¦ permits maximum individual choice† (Anderson, 1978, p. 3). The key is that the consumer must be able to make a voluntary choice without feeling coerced. DTC ads should not rely on deceptive or manipulative tactics. As previously stated, the consumer can be viewed as a vulnerable audience if the y are being spoken to at a level that is beyond their ability to understand (Baker & Martinson, 2001, p. 166). Ethical marketing requires that these audiences not be unfairly targeted because of this vulnerability. DTC advertising ethics is concerned with what drug companies ought or ought not to do. Lying is morally wrong and therefore considered unethical. Using lies or false impressions in a DTC ad distorts the information a consumer receives and can alter the choices they may make (Baker & Martinson, 2001, p. 160). Therefore DTC ads should not create false impressions or omit pertinent information just for the sake of the ad. The point of DTC advertising should not be increased sales but be more of a means to an important social end which should be consumer education. An example of an ethical advertisement would be one that utilizes those messages that demonstrate respect for the consumer to whom they are directed. Respecting the consumer means that their needs are placed before the needs of the advertiser. Currently, the DDMAC does not regulate the ethicalness of pharmaceutical advertising. Their mission statement is, â€Å"To protect the public health by assuring prescription drug information is truthful, balanced and accurately communicated.† (FDA, 2010) â€Å"Ethical ads tell the truth about their product and do not try to distort its capabilities or hide its defects.† (Vaux) Unfortunately an ad can be truthful and still be considered unethical. Ads that play to â€Å"base† human emotions such as fear can be considered unethical as they are just trying to promote emotions that would cause the consumer to seek relief through the advertiser’s product. Conclusion Direct-to-consumer advertising has been integrated into our culture and is likely not going to go away. Just as there are those who lobby against these ads, there are an equal number of proponents who support them. Regulations have been changed to allow the advancement of these ads to their current place in our society. As such, the DDMAC is constantly monitoring DTC ads and will need to be the ones to set ethical boundaries and ensure they’re being adhered to. Consumers must evaluate pharmaceutical ads critically so as not to be persuaded as much as they are educated. Although proponents of DTC advertising argue they provide important consumer information, too frequently the ads can operate dysfunctionally by â€Å"providing misinformation and inducing the consumer to make purchases that are not in either their short or long term interest.† (Baker & Martinson, 2001, p. 151) Ethical DTC ads should serve an educational purpose first and a promotional purpose second. They should offer consumers information on alternatives along with true representations of the risks their medications may have. Unethical ads are those that may try to point out your flaws, i.e. depression, and then tell you they have the answer, i.e. Prozac. These unethical ads will use your emotions to cause you to believe you are in need of a fix when in reality you may not be. I believe there is a place for direct-to-consumer advertising. Consumers are constantly looking for more and more information to help them make better informed decisions. DTC ads, when done appropriately, can be used to provide this information not only about medications but health conditions as well. Decreasing public stigma around certain health issues is another advantage advertising can bring; especially if it opens doors for patients to have difficult discussions with their doctors. That being said, I believe that a balance lies with the FDA needing to take a more proactive role in how they manage DTC ads. I think that all ads should be required to go through a pre-approval process rather than the current release and retract method. It is hard to take back something that has already been seen and that may cause damage to the consumer. References Direct-to-consumer advertising. (2010, June 11). Retrieved March 4, 2012, from Sourcewatch: http://www.sourcewatch.org/index.php?title=Direct-to-consumer_advertising Anderson, K. E. (1978). Persuasion: Theory and practice. Boston: Allyn & Bacon. Baker, S., & Martinson, D. L. (2001). The TARES test: Five principles of ethical persuasion. Journal of Mass Media Ethics, 16(2), 148-175. Evans, G. W., & Friede, A. I. (2003). The Food and Drug Administration’s regulation of prescription drug manufacturer speech: A first admendment analysis. Food and Drug Law Journal, 58(3), 365-437. FDA. (2010, April 4). Drugs. Retrieved March 4, 2012, from FDA: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/ucm071964.htm GAO. (2006). Prescription drugs: Improvements needed in FDA’s oversight of direct-to-consumer advertising. Pfizer. (2011). Ethical Sales and Marketing. Retrieved March 5, 2012, from Pfizer: http://www.pfizer.com/investors/financial_reports/annu al_reports/2010/ethics-sales.jsp U.S. Department of HHS. (1999). Guidance for Industry Consumer-Directed Broadcast Advertisements. Food and Drug Administration. U.S. Department of Health and Human Services. Vaux, R. (n.d.). What is the