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Anyone who watches TV in the United States is probably familiar with "direct-to consumer" (DTC) advertising for prescription drugs.
Provided by drug companies, these ads are aimed at a general audience, and not at health care professionals such as doctors, nurses, and pharmacists. The ads are broadcast on TV and radio, and published in magazines and newspapers. They also appear online.
DTC advertising often features celebrity spokespeople, computer generated characters, or actors portraying happy and satisfied patients.
A standout trait of these ads on TV is the narrated list of a drug's potential side effects. This list is required. Prescription drug makers must provide risk information in any promotion that qualifies as a product-claim advertisement.
The United States is one of the few places in the world that allow DTC advertising. (New Zealand is the only other developed nation that does.)
FDA oversees prescription drug advertising with the Federal Food, Drug, and Cosmetic Act and related regulations.
Through its Division of Drug Marketing, Advertising, and Communications (DDMAC), FDA ensures that all prescription drug promotion provided by drug firms is truthful, balanced, and accurately communicated.
Part of FDA's Center for Drug Evaluation and Research (CDER), DDMAC recently hired 12 new reviewers to help evaluate promotional pieces submitted to the agency. With these additional staffers, the division has 28 primary reviewers.
Drug companies are generally required to include all of a drug's risk information in a product claim ad.
In print ads, this is usually done in a section called the "Brief Summary." Despite its title, this summary would take many minutes to read or scroll down a TV screen. This is where the long list of side effects in the TV ads comes into play.
Broadcast ads are allowed to include only the most important risk information—as long as the ads tell viewers or listeners how to get the full FDA-approved prescribing information, which describes all of the drug's risks.
These broadcast ads must give a number of sources that can provide a drug's prescribing information. These sources may include
DTC advertisements come in three forms.
While DTC advertising has many supporters, it raises concerns for many people.
Proponents say that the ads
However, many people are concerned that such promotion
FDA encourages companies that offer DTC advertising to include accurate information in their ads. Through a comprehensive surveillance and enforcement program, the agency ensures that consumers are not misled or deceived by advertisements that violate the law.
In addition, FDA advances and encourages better communication of labeling and promotional information to health professionals and to consumers.
FDA recently launched a new Web site: "Be Smart About Prescription Drug Advertising, A Guide for Consumers."
The site is designed to educate consumers about how to view direct to consumer (DTC) advertising, prepare them for discussions with health care providers, and help improve patient understanding and medical care.
The site includes these tips:
The online guide also provides the following:
The Web page also offers information on "The Basics" of drug ads and a question-and-answer section.
Visit "Be Smart About Prescription Drug Advertising, A Guide for Consumers" at www.fda.gov/cder/ethicad/
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
FDA Division of Drug Marketing, Advertising, and Communications
www.fda.gov/cder/ddmac/
Be Smart About Prescription Drug Advertising, A Guide for Consumers
www.fda.gov/cder/ethicad/background.htm
Date Posted: September 30, 2008