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including a failure to disclose the safety risks in Bayer's marketing of its cholesterol drug Baycol, which was withdrawn in 2001.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 Coakley.
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)