Action Alert: FDA Safety Review Needs Tune-Up
In 2002, staff within the Food and Drug Administration’s (FDA’s) safety division analyzed reports linking heart failure to use of the diabetes drugs Avandia and Actos. 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.
It’s time to do something. The drug safety division monitors drugs after they have been approved. But these experts do not have the power to act on important safety findings.
Last year Senators Chris Dodd (D-Conn.) and Charles Grassley (R-Iowa) introduced legislation to give the safety division more authority, but it was not included in the FDA Revitalization Act recently passed by the Senate. The bill has not yet passed in the House, which means there is still time to make this change. Tell Congress to pass an amendment that will put safety first!