Drug Web Ads Changing After FDA WarningApr 28, 2009 | Parker Waichman LLP The U.S. Food and Drug Administration (FDA) has long been concerned about misleading drug marketing campaigns. Now, reports MainStreet.com, some online drug ads do not meet advertising requirements and agency regulations. GlaxoSmithKline, Pfizer, Merck, and Eli Lilly are among the 14 drug makers told by the FDA their ads are not in compliance.
Some ads were yanked, said MainStreet.com, with replacements that do not mention drug brand names. Citing an FDA letter to one firm, the ads—which Google limits to 95 characters—“misbrand” the drugs and “fail to communicate any risk information associated with the use of these drugs,” reported MainStreet.com. To comply, such marketing must include risk and benefit information. When risk information is omitted, drugs appear safer and more effective, noted MainStreet.com, citing the FDA.
MainStreet.com pointed to a Propecia hair loss treatment ad in which there was no mention of the drug not being approved for use in women or children and also reported that some ads do not explain when a medication must be used with another treatment. Worse, some drug makers now run ads that include Website addresses (URLs), but no medication name, said MainStreet.com. The URLs lead consumers to “promotional” sites about the drug. For example, Biogen was running a Google ad for its multiple sclerosis medication, Tysabari, which said, "Satisfied with your MS treatment or looking for something different?" quoted MainStreet.com. The ad then linked the consumer to Tysabri.com. Although since amended, said MainStreet.com, to read “MyMSTreatment.com,” consumers are still linked to the drug’s site.
Consumers looking for information on a disease may not understand that they are being led to a drug maker site and are reading information about a treatment, not a disease, said MainStreet.com. By advertising in this way, pharmaceutical companies are, technically, in compliance with FDA mandates, but not educating consumers about treatments.
Other direct-to-consumer (DTC) ads have been the subject of much criticism, such as Glaxo’s Avodart, prescribed to treat symptoms of enlarged prostate. Glaxo ran an ad that featured a man working on a model of the solar system and who must stop painting to “make frequent trips to the bathroom,” said the Star Tribune in a prior report. A colleague then suggests Avodart, saying that "other medicines, they don't treat the cause, because they don't shrink the prostate." FDA regulators, reported the Star Tribune, said the claim is bogus and in a letter to Glaxo’s U.S. officials, wrote that Merck’s Proscar, reduces prostate size, and “has a similar indication,” stating that, "Nothing in the labeling for Avodart suggests any specific advantage."
In February, Consumer Reports questioned the ethics of a Chantix (varenicline) ad that, while never mentioning Chantix by name, appeared to market the drug while seeming to be a public service announcement. The commercial focused on a Website dedicated to smoking cessation entitled MyTimeToQuit.com and presented information in a public service format, said Consumer Reports, pointing out that it is only at the end of the commercial that hints about the ad’s origin—Pfizer—are discreetly revealed. The FDA approved Chantix in 2006; side effects may include suicidal thoughts, depression, and even violent behavior.