What the Food and Drug Administration (FDA) wanted Bayer to clarify are what the agency considers misleading statements about the drug’s ability to improve women’s moods and clear up acne while downplaying the drug’s potential health risks. Yaz, also known as Yasmin or the generic Ocella, is currently being blamed for increasing women’s risk of serious adverse events such as heart attack, stroke, pulmonary embolism and death.

The warning the FDA issued to Bayer is one of 41 enforcement notices sent to drug companies by the agency’s Division of Drug Marketing, Advertising and Communication (DDMAC) in 2009. The company issued 21 in 2008. DDMAC head Thomas Abrams says the increased number of warning letters is a direct result of FDA chief Dr. Margaret Hamburg’s pledge to crack down on makers of drugs and medical devices for questionable promotional messages.

“We’re trying to get the point across to industry that we want them to comply with the law because it affects public health,” Abrams said. “If you don’t comply with the law, we are going to take action. We are not going to tolerate having consumers or health care professionals misled.”

As part of a settlement on the charges of deceptive consumer advertising, Bayer agreed to run the clarification ads, and for the next six years submit all ads for Yaz to the FDA for screening before they appear.

Sources:
New York Times
Reuters

SOURCE: Yaz Lawsuit › FDA cracks down on deceptive advertising of drugs