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 “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 “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 humans 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, “the FDA can work with the Department of...
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