Monitoring the claims of consumer advertising
[Editor’s note: This is the second of a two-part series on the impact of consumer-directed prescription drug advertising. In the December 1998 Contraceptive Technology Update, p. 153, we offered information on changes in U.S. Food and Drug Administration (FDA) advertising regulations. The following article covers the role of the FDA’s watchdog agency in monitoring such advertising and the contraceptive manufacturers who were cited in 1998 for violations of FDA advertising rules.]
When it comes to advertising prescription drugs, the U.S. Food and Drug Administration regulates consumer-directed ads under the same rules as those it targets to health care providers.
Consumer ads, just like those aimed at pro viders, must make claims that are supported by scientific evidence and consistent with the FDA-approved product labeling. And just like provider advertising, consumer pitches must not present false or misleading information.
FDA guidance requires that consumers be able to understand the benefits and limitations of an advertised drug. The agency monitors ads to make sure they are easily understood and designed for their target audience. For example, ads may be considered misleading unless they clearly explain a drug’s benefits and risks in everyday language.
The goal of any prescription drug ad is to promote what the FDA terms "fair balance." This balance is achieved by prominent presentation of the risks, with no overemphasis of the benefits.
The revision of broadcast direct-to-consumer advertising guidance has changed the way the FDA prioritizes its workload, says Norman Drezin, RPh, JD, deputy director of the FDA’s division of drug marketing, advertising, and communications in Rockville, MD. The division, which operates within the FDA’s center for drug enforcement and regulation, is charged with monitoring all prescription drug advertising materials.
"We get a lot of material coming to us, so to us, [broadcast advertising] is another piece," Drezin explains. "We do look at it with a little more priority because of its impact, its broad dissemination of information."
Monitoring violations
The division continues to keep a sharp eye out for violations of the federal Food, Drug, and Cosmetic Act, whether they are made in a press release, a consumer print ad, or a television commercial. According to information posted by the FDA center’s freedom of electronic information office, 125 companies have been cited for violations in 1998.
Six of those companies were cited specifically for violations in connection with information disseminated regarding contraceptives:
• Pharmacia and Upjohn of Bridgewater, NJ (Depo-Provera);
• Organon of West Orange, NJ (Mircette, Desogen);
• Wyeth-Ayerst of Philadelphia (Alesse, Lo/Ovral, Nordette, Triphasil);
• Searle of Skokie, IL (Demulen, Tri-Norinyl);
• Watson Laboratories of Corona, CA (Trivora, Zovia, Necon, Levora, Nor-QD);
• Ortho-McNeil of Raritan, NJ, received a citation in 1997 for a consumer ad for Ortho Tri-Cyclen.
The contraceptive manufacturers’ violations were addressed by the FDA in what are known as "untitled letters," used for the least serious violations of advertising regulations. (To review the letters on line, go to the FDA’s center for drug enforcement and regulation World Wide Web site at http://www.fda.gov/cder/handbook/index.htm. Click on "Post Drug Approval Process," "Pre scrip tion Drug Advertis ing and Promotional Labeling," "DDMAC Home Page," and "Informa tion for Industry.")
The majority of violations stem from the manufacturers’ claims that a particular oral contraceptive (OC) is unique or superior to another. Such claims must be backed up by adequate clinical comparative trials, states the FDA.
Other violations include failure to adequately disclose risks, especially the fact that no OC protects against HIV and other sexually transmitted infections.
Under this ruling, the following claims are misleading because they purport superiority or fail to provide adequate substantiation:
• Alesse: "a balanced combination that’s just right for new starts."
• Demulen: superiority due to its low and rogenic potential or low incidence of side effects.
• Depo-Provera: Two television ads ("Barbecue" and "Birthday") fail to adequately direct consumers to other sources of additional product information.
• Desogen: "My body knows the difference."
• Levora: having specific characteristics that make it clinically significantly different from another, or that it is specifically indicated for a particular patient or population.
• Lo-Ovral: "the physician’s first choice when it comes to switching OCs."
• Mircette: "Uniqueness is based on the patented shortened hormone-free interval."
• Necon: "low risk of acne, oily skin, hirsuitism, weight gain."
• Nordette: "the patient acceptance of levonorgestrel."
• Ortho Tri-Cyclen: "announcing a birth control pill that’s also a beauty aid."
• Triphasil: "No OC is better than Triphasil at reducing menstrual irregularities."
• Tri-Norinyl: "similar yet different."
• Trivora: "minimize[s] androgenic side effects such as hirsuitism, chronic anovulation, polycystic ovarian disease, acne, bloating and weight gain, reduced libido."
• Zovia: "low androgenic potential."
"In each letter, we articulate what we would like done," Drezin says. "Usually, it’s to discontinue the dissemination of the material."
Drezin categorizes the relationship between the regulatory agency and the companies as "fairly cordial." In most instances, companies agree to stop releasing the material in question, he says.
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