BOSTON Feb 9 German drugmaker Bayer AG
BAYG.DE has agreed to submit any television advertisements for
its oral contraceptive Yaz to U.S. regulators for approval and
conduct a $20 million corrective advertising program, according
to Massachusetts Attorney General Martha Coakley.
The agreement comes as part of a supplement to a 2007
court-entered judgment, Coakley said in a statement.
The latest judgment, filed in Massachusetts' Suffolk
Superior Court, resolves allegations that Bayer's 2008 marketing
of Yaz violated the terms of the 2007 agreement by not
disclosing the uses for which Yaz has been approved by the U.S.
Food and Drug Administration.
The 2007 agreement involved allegations of deceptive
advertising, including a failure to disclose the safety risks in
Bayer's marketing of its cholesterol drug Baycol, which was
withdrawn in 2001.
The latest judgment requires Bayer to submit all Yaz
television advertisements to the FDA for approval and to comply
with all changes suggested by the agency. It requires Bayer to
conduct a $20 million corrective advertising program.
In an earlier warning letter to Bayer, the FDA had addressed
two direct-to-consumer advertisements where it said Bayer
improperly broadened promotion of Yaz to include symptoms of
premenstrual syndrome, or PMS, when Yaz was not approved to
treat this condition.
Yaz is approved to treat a more serious condition known as
premenstrual dysphoric disorder, or PMDD, which causes anxiety,
tension, persistent anger and other symptoms.
The FDA's letter also warned Bayer about overstating the
effects Yaz had on acne, according to the statement from
Twenty-six states aside from Massachusetts took part in the
action against Bayer, Coakley's office said.
(Reporting by Toni Clarke, editing by Matthew Lewis)