FDA Warns Drug Makers on Misleading Promotions

Some pharmaceutical firms —including Gilead Sciences and Biogen Idec—were warned by the U.S. Food & Drug Administration (FDA) about <"http://www.yourlawyer.com/practice_areas/defective_drugs">misleading promotions, said Reuters.

In its letters, the FDA warned Gilead Sciences about its direct-to-consumer (DTC) print ads for Truvada, Gilead’s HIV medication, pointing to a “multiple-page ad” that suggested, “Truvada is better or more effective than has been demonstrated,” quoted Reuters. In the ad, pictures of a female patient taking Truvada during her life “appears to be happy and in good health,” according to the letter, said Reuters.

According the FDA, the ad’s claims could result in patients wrongly believing their illness could be managed long-term—a point not established since the medication was only studied for three years, said Reuters. The ad’s small print references the study but, said the FDA, that information “does not mitigate the overwhelming impression created by the prominent images,” quoted Reuters.

The FDA also issued a warning to Biogen over its Web cast promoting Tysabri, a multiple sclerosis treatment, said Reuters. The video, said the agency in its letter, “is false or misleading because it minimizes important risks associated with the use of Tysabri and omits the drug’s approved indication,” quoted Reuters. “We are particularly concerned with this Web cast because it presents numerous statements that seriously minimize the risk of PML (progressive multifocal leukoencephalopathy),” the FDA added, pointing out that this is an established challenge.

The FDA, said Reuters, also issued the letter “privately” to Aton Pharma Inc. and sent a warning letter to Salix Pharmaceuticals.

We’ve been following the issue of misleading Big Pharma DTC ads and wrote last May that the FDA released proposed guidelines for drug and medical device television ads meant to reduce diversion tactics. In August, USA Today reported that the $4.3 billion advertising sector was facing strong opposition from lawmakers hoping to put a stop to the advertising trend. Lawmakers argued that DTC advertising is responsible, in part, for the rising cost of health care and that the ads, described as “complicated,” discuss illnesses about which consumers might not even be aware.

FDA guidelines suggest that both benefits and risks be explained in similar type styles and voice-overs in DTC ads, said Reuters previously. The 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.

Earlier last year GlaxoSmithKline was cited by the FDA for its ad for prostate drug Avodart because the ad’s claim was bogus and “Nothing in the labeling for Avodart suggests any specific advantage,” according to its letter.

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, with hints about the ad’s origin—Pfizer—only discreetly revealed. Chantix 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 its birth control medication Yaz after the FDA sent Bayer a warning letter over two Yaz televisions ads that misled consumers into believing Yaz could help relieve symptoms for which the drug was never approved. Moreover, these birth control pills are related to a wide range of Yaz side effects Bayer does not warn about. Bayer was required to implement a $20 million dollar campaign to “remedy” the misinformation it promoted and submit all subsequent television ads to the FDA for pre-approval, among other mandates.

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