Connecticut Attorney General's Office
Press Release
Attorney General Announces New Terms To 2007 Bayer Judgment Involving Direct-To-Consumer Marketing
Date, 2009
The 2007 agreement concerned alleged deceptive advertising of Bayer products, including failure to disclose safety risks in marketing its cholesterol-lowering drug, Baycol.
Today's judgment resolves allegations that Bayer's 2008 marketing of the oral contraceptive Yaz violated the earlier agreement by misleading consumers about the drug's benefits and approved uses.
The supplemental settlement filed in Superior Court in Hartford today requires Bayer to submit all future direct-to-consumer television advertisements for Yaz to the U.S. Food and Drug Administration (FDA) for review and comment prior to dissemination in the marketplace.
Bayer must comply with all regulatory comments by the FDA regarding the advertising. In all Yaz print advertisements, Bayer must clearly and conspicuously disclose the drug's FDA-approved uses.
Blumenthal, and attorneys general from 26 other states, worked closely with the FDA's Division of Drug Marketing, Advertising, and Communications to craft today's supplemental settlement.
Blumenthal said, "Today's settlement is a powerful prescription for integrity in pharmaceutical marketing.
"Bayer blatantly broke its promise made two years ago in court -- to responsibly market its drugs and disclose dangers to doctors and the public. Bayer egregiously exaggerated the efficacy of Yaz, an oral contraceptive, as an acne treatment. The company's deliberate deceit endangered patient health and public trust.
"This settlement sends a message to the industry that we will be vigilant against misleading drug claims. Our federal-state partnership will continue to focus aggressive scrutiny and oversight on marketing practices.
"My office will continue to work with other states and the federal government -- now under a new and reinvigorated administration -- to fight false and misleading drug advertising."
In an earlier warning letter to Bayer, the FDA addressed two misleading direct-to-consumer television advertisements for Yaz where Bayer "broadened" the drug's approved uses to include treatment of relatively common premenstrual syndrome (PMS). In reality, Yaz is not approved to treat this condition.
The FDA also warned Bayer about promoting Yaz for treating acne. The company allegedly exaggerated the efficacy of Yaz in acne treatment, and such use is unapproved by the FDA.
Tom Abrams, director of the FDA's Division of Drug Marketing, Advertising, and Communications, added, "This is a great example of collaboration between the FDA and state attorneys general. By working together, we can achieve excellent results and double our efforts to clean up misleading advertising in the marketplace. This significantly benefits the public by ensuring that consumers are not misled about information relating to their health."
In addition to changes in its advertising policies, Bayer must conduct a $20 million corrective advertising program to remedy misinformation from the earlier YAZ advertisements.
Consumers wanting more information on this case and consumer protection in Connecticut may contact Blumenthal's office at 860-808-5420 or by email at attorney.general@po.state.ct.us.