FDA Issues DTC Advertising Guidelines

The U.S. Food and Drug Administration (FDA) just released proposed guidelines for <"http://www.yourlawyer.com/practice_areas/defective_drugs">drug and medical device television ads meant to reduce diversions to consumers. Reuters reported that the agency said such ads should steer clear of images and music that sidetracks viewers from critical information on potential side effects.

The guidelines suggest that both benefits and risks be explained in similar type styles and voice-overs, said Reuters. The proposed guidelines were prompted by complaints pointing to drug maker tactics to minimize risks and play up benefits via distracting music and type styles, explained Reuters.

Direct-to-consumer (DTC) ads have long been criticized. Earlier this year GlaxoSmithKline was cited by the FDA when it ran an ad for the prostate drug Avodart 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, “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 … 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, appeared to market the drug while seeming to be a public service announcement. The commercial focused on a smoking cessation Website entitled MyTimeToQuit.com that presented information in a public service format, said Consumer Reports, pointing out that it is only at the end of the ad that hints about the ad’s origin—Pfizer—are discreetly revealed. The FDA approved Chantix in 2006; side effects may include suicidal ideation, depression, and violent behavior.

As part of a settlement with 27 states, Bayer had to change how it advertises birth control medication Yaz, reported BizJournal previously. Late last year, the FDA sent Bayer a warning letter over two Yaz televisions ads that misled consumers into believing Yaz could help relieve symptoms associated with Pre-Menstrual Syndrome (PMS) and could help in the treatment of specific types of acne. The FDA has never approved Yaz for either of these medical issues, said BizJournal. Bayer was mandated to implement a $20 million dollar campaign to “remedy” the misinformation it promoted and must submit all subsequent television advertisements to the FDA for pre-approval; comply with the FDA on TV and print advertisement suggestions; and “clearly and conspicuously” disclose for what the FDA has approved when discussing—in its print ads—those symptoms Yaz can treat, said BizJournal.

Reuters pointed to the trend of filming healthy, active, happy patients during ads’ benefits section while speeding through and using distracting music and print when filming risk information. Omitting or minimizing information on side effects is the most common violation cited by the FDA in letters to drug makers regarding misleading marketing, said Reuters. The new guidelines seek—but do not mandate—remedies such as explaining how to provide risk information in print and aired marketing to consumers and doctors, such as use of color to highlight details and how to place and time such information, said Reuters.

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