"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 badad@fda.gov. 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.