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Attorney
General Gansler Reaches Settlement with Bayer Corporation Regarding
its Marketing of Yaz Oral Contraceptive
Settlement Adds Terms
to 2007 Judgement Against Bayer
BALTIMORE, MD (February 9, 2009) - Attorney
General Douglas F. Gansler announced today that his Consumer
Protection Division,
along with the Offices of Attorneys General from 26 other states,
has reached a settlement with Bayer Corporation concerning misleading
advertisements of its Yaz oral contraception product. The Attorney
General alleged that Bayer’s televised ads for Yaz were misleading
because they promoted Yaz as a treatment for common premenstrual
syndrome (PMS) and for types of acne when the product has not been
approved by the United States Food and Drug Administration (“FDA”)
for such uses. The FDA has previously issued a warning letter to
Bayer addressing the advertisements and the FDA collaborated with
the Attorneys General in reaching this settlement.
The settlement adds
new requirements to a 2007 Consent Judgment agreed to by Bayer
concerning its product advertising. The 2007
agreement concerned problems with alleged deceptive advertising
of Bayer products, including non-disclosure of safety risks associated
with Bayer’s marketing of its product Baycol. The new requirements
under the Yaz settlement requires Bayer to submit all future “direct
to consumer” Yaz advertisements to the FDA for review and
comment prior to their being broadcast to consumers. Bayer has
also agreed to comply with all regulatory comments the FDA makes
concerning the advertising and to clearly and conspicuously disclose
the approved uses of Yaz.
“Pharmaceutical companies cannot market drugs to consumers
for uses that have not been approved by the FDA,” said Attorney
General Gansler. “This settlement should provide consumers
better, more accurate information about how this product may be
used.”
In addition to changing its advertising policies, Bayer also
agreed to conduct a $20 million corrective advertising program
to remedy misinformation from the misleading Yaz advertisements.
The settlement agreement has been filed in the Circuit Court for
Baltimore City and must now be approved by that Court.
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