Tell Congress: Improve Health Safety - Give Experts the Authority to Act and Protect People who use a drug called Avandia have a 43 percent increase in their risk of heart failures says a study in the New England Journal of Medicine. The FDA has known about the increased risk for FIVE years. The scientists at the FDA recommended the labels include information about the large number of reports of heart failure in patients taking Avandia and Actos in 2002. The FDA did not make the suggested changes. Right now there is an opportunity to correct the practices at the FDA that lead to this mishap. Currently, the drug safety division monitors drugs after they have been approved yet they have no power to act on important safety findings. Senators Chris Dodd (D-Conn.) and Charles Grassley (R-Iowa) introduced legislation to give the safety division more authority. The FDA Revitalization Act recently passed the Senate but it has not yet passed the House and can be amended with the Dodd/Grassley legislation. Write your Member of Congress today. Tell them to give the FDA experts the power to act on safety issues.

November 21, 2009 Subject: For the past five years, drug safety experts within the Food and Drug Administration (FDA) had important post-marketing evidence linking heart failure to use of the diabetes drugs Avandia and Actos. In 2002, these experts recommended changing the drug label’s warning section to reflect these risks more clearly — but the FDA did not make the suggested changes. This is the result of a dangerously flawed distribution of duties within the FDA. I propose a change. The drug safety division should remain a part of the FDA – but it should be separate from the rest of the FDA’s Center for Drug Evaluation and Research (CDER). Instead, the CDER should focus primarily on deciding whether or not to approve drugs for use and the safety review division should have the authority to take action if they find that a drug is too risky. This could mean requiring more testing of a drug to address unanswered safety questions, adding a stronger warning to a drug's label, or banning an unsafe drug. Last year Senators Chris Dodd (D-Conn.) and Charles Grassley (R-Iowa) introduced legislation to make the safety division independent. This legislation was not included in the FDA Revitalization Act recently passed by the Senate, but could still be added to the House version. Do not support any version of FDA legislation that does not create an independent office for post-marketing drug safety. We will add your signature from the information you provide.		First Name* Last Name* Email* Street* Street 2 Street 3 City* State/Province* Select a state Alabama Alaska American Samoa Arizona Arkansas California Colorado Connecticut Delaware D.C. Florida Georgia Guam Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Northern Mariana Islands Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virgin Islands Virginia Washington West Virginia Wisconsin Wyoming Armed Forces (the) Americas Armed Forces Europe Armed Forces Pacific Alberta British Columbia Manitoba Newfoundland New Brunswick Nova Scotia Northwest Territories Nunavut Ontario Prince Edward Island Quebec Saskatchewan Yukon Territory Other Zip/Postal Code*