November 13,2007

Press Contact:

Grassley questions government response to the marketing and use of unapproved drugs

WASHINGTON – Sen. Chuck Grassley is asking top officials for the Food and Drug Administration and the Centers for Medicare and Medicaid Services to respond to questions about their agencies’ oversight of the marketing of prescription drugs that have not been approved by the FDA and illegitimate billing of the Medicaid program for unapproved drugs.

In response to a Grassley inquiry last year, the FDA acknowledged that its system for finding unapproved drugs is limited, stated that the agency had initiated multiple enforcement actions and would continue to try and get companies to file for marketing approval, and said that it created a website on unapproved drugs to address consumer questions and make available important documents on the issue.