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1 AMERICAN MEDICAL ASSOCIATION HOUSE OF DELEGATES 2 3 4 Resolution: 213 5 (A-09) 6 7Introduced by: Michigan Delegation 8 9Subject: Stricter Fines for Violating Direct-to-Consumer Advertisements 10 11Referred to: Reference Committee B 12 (Monica C. Wehby, MD, Chair) 13 14 15Whereas, The US Food and Drug Administration (FDA) has the power to fine the 16pharmaceutical companies; and 17 18Whereas, The FDA has played a crucial role1 in the $634 million in fines imposed on Purdue 19Pharma regarding its pain killer Oxycontin; and 20 21Whereas, The FDA has imposed a fine of $4.2 million2 on the Red Cross for failure to comply 22with requirements under federal laws and FDA regulations relating to the collection of blood 23products; and 24 25Whereas, The FDA has issued mere warning letters to Bayer AG for misleading ads on the birth 26control pill Yaz; therefore be it 27 28RESOLVED, That our American Medical Association lobby the US Food and Drug 29Administration for stricter sanctions and monetary fines against pharmaceutical companies for 30flouting the guidelines regarding direct-to-consumer advertisements. (Directive to Take Action) 31 32Fiscal Note: Staff cost estimated at less than $500 to implement. 33 34Received: 05/06/09

11 FDA Law Enforcers Protect Consumers' Health inside the Office of Criminal Investigations 2http://www.fda.gov/consumer/updates/oci072307.html

32 . FDA Fines American Red Cross $4.2 Million for Failure to Meet Established Blood Safety Laws 4http://www.fda.gov/bbs/topics/NEWS/2006/NEW01447.html