Healthy Skepticism Library item: 15024

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Mass. AG Martha Coakley Enters Agreement with Bayer Corporation Resolving Allegations of Deceptive Advertising of Oral Contraceptive
Pharma Live 2009 Feb 9
http://pharmalive.com/news/index.cfm?articleID=603686

Abstract:

Bayer must now submit proposed television ads for “Yaz” to the FDA for approval and devote $20M to correcting misinformation from prior television advertisements

Full text:

Today, Massachusetts Attorney General Martha Coakley’s office, along with 26 other states, reached an agreement with Bayer Corporation that supplements the requirements of a 2007 court-entered judgment concerning the advertising of Bayer products. The 2007 agreement involved allegations of deceptive advertising of products, including non-disclosure of safety risks associated with its marketing of Baycol. Today’s stipulated judgment, filed in Massachusetts’ Suffolk Superior Court, resolves allegations that Bayer’s 2008 marketing of the oral contraceptive Yaz violated the terms of the 2007 agreement by not disclosing the uses the Food and Drug Administration (FDA) has approved for Yaz. Today’s judgment requires Bayer to submit all television advertisements to the FDA for pre-approval, and to comply with all changes suggested by the FDA.

“Clear, concise and honest information from drug companies is vital for consumers to make informed choices about medications,” Attorney General Coakley said. “Today’s judgment is an excellent example of the states and the federal government coming together to safeguard the public against false and misleading advertisements that adversely effect the health and well being of our citizens.”

The judgment entered today requires Bayer to disclose in print advertisements what uses the FDA has approved for Yaz. In addition to changes in its advertising policies, Bayer must also conduct a $20 million corrective advertising program to remedy misinformation from the misleading YAZ advertisements.

In an earlier warning letter to Bayer, the FDA addressed two misleading direct-to-consumer advertisements for Yaz including one where Bayer “broadened” the promotion to include the symptoms of relatively common premenstrual syndrome (PMS) when, in fact, Yaz was not approved to treat this condition. The letter also warned Bayer about overstating the effects Yaz had on acne.

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 Massachusetts, the following states participated in this action against Bayer: Arizona, Arkansas, California, Connecticut, Delaware, Florida, Idaho, Illinois, Iowa, Kansas, Kentucky, Maine, Maryland, Michigan, Mississippi, Montana, Nevada, North Carolina, Ohio, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Washington, and Wisconsin.

This matter was handled for Massachusetts by Assistant Attorney General April English of Attorney General Coakley’s Consumer Protection Division.