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An agreement has been made with Bayer Corp. on Monday, February 9, 2009 with the Massachusetts Attorney General’s office, as well as 26 other states. The agreement had to do with allegations that Bayer’s 2008 marketing campaign of the birth control pill, Yaz, violated the terms of a 2007 agreement by not disclosing the uses the Food and Drug Administration had approved for Yaz.
According to Monday’s judgment, Bayer will be required to submit all television advertisements to the FDA for pre-approval and will be required to comply with all changes suggested by the FDA. Bayer will also have to disclose the uses of Yaz that have been approved by the FDA in any print advertisements. In addition to changing its advertisements, Bayer also has to perform a $20 million corrective advertising campaign to remedy misinformation from the Yaz advertisements.
The FDA had sent an earlier warning letter to Bayer, which addressed two misleading direct-to-consumer advertisements for Yaz. In one of the advertisements, Bayer promoted Yaz as a way to treat the symptoms of relatively common premenstrual syndrome (PMS) when the company had not been given an approval to treat this condition. The FDA letter also warned Bayer about overstating the effects Yaz had on acne.
“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,” said Tom Abrams, director of the FDA’s Division of Drug Marketing, Advertising, and Communications.
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