"Last month, FDA sent a warning letter to Biogen Idec, Inc., for downplaying the risks of progressive multifocal leukoencephalopathy (PML), a rare, but often fatal, brain infection that has been linked to the multiple sclerosis drug Tysabri. The statements were made in a series of webcasts used to promote the drug between late October and early November of 2009."
Federal drug regulators are hoping to recruit doctors in the hunt for misleading drug advertisements through a new initiative aimed at marketing materials that provide inaccurate or misleading information, or make statements that downplay or omit the negative side effects of drugs.
The FDA unveiled its new “Bad Ad Program” this week, which is sponsored by the agency’s Division of Drug Marketing, Advertising, and Communications (DDMAC). The program is aimed at getting health care providers to pay more attention to presentations and advertisements, and FDA officials hope it will give them an eye into private promotional activities where FDA regulators are not present.
The agency will focus on providing educational materials to doctors, bringing attention to the most common forms of misleading drug advertisements. Health care professionals will be encouraged to report potential violations at email@example.com. They will be allowed to report anonymously if necessary.
“The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” according to Thomas Abrams, director of DDMAC.
The new program comes after a number of drug makers were warned by FDA about misleading advertisements; many of which were at conferences or in internet videos targeting health care providers.
Last month, FDA sent a warning letter to Biogen Idec, Inc., for downplaying the risks of progressive multifocal leukoencephalopathy (PML), a rare, but often fatal, brain infection that has been linked to the multiple sclerosis drug Tysabri. The statements were made in a series of webcasts used to promote the drug between late October and early November of 2009.
In January ,the FDA fired off warnings to Amylin Pharmaceuticals, Eli Lilly and Co., Bayer Healthcare Pharmaceuticals and Cephalon. In the letter to Amylin, the FDA cited the company for promoting Byetta as a stand-alone diabetes drug at the Endocrine Society’s Annual Meeting, before it was approved as such. Eli Lilly was warned that its direct-to-consumer print advertisements for the antipsychotic Cymbalta buried health risk information and made it appear unrelated to the drug. Cephalon was cited for omitting health risk information on pocket dosing cards for Treanda, a leukemia medication.
Bayer Healthcare also received a letter accusing the company of overstating the effectiveness of the Mirena intrauterine device (IUD) and minimizing health risks in a live consumer-directed program where representatives travel to consumers’ homes.
Bayer has run into trouble in the past with the FDA over marketing claims involving its contraceptive products. In late 2008, the FDA and several state attorney generals forced Bayer to run a $20 million corrective advertising campaign for its Yaz birth control pills because prior marketing contained false claims about the drug’s acne and PMS-fighting benefits, and did not clearly state all of the known Yaz side effects, drowning some of them out with loud music. As a result of the misleading advertisements, Bayer agreed that the FDA will screen future Yaz ads for six years before they can be aired.