February 09,2006

Grassley Highlights Unexpected FDA Panel Move on Attention Deficit Medicines

M E M O R A N D U M

To: Reporters and Editors
Re: FDA advisory panel action on ADHD Drugs
Da: Thursday, Feb. 9, 2006

Earlier this week, Sen. Chuck Grassley, chairman of the Committee on Finance, wrote to the
Food and Drug Administration (FDA) urging a comprehensive, more timely review of the safety
risks associated with Attention Deficit Hyperactivity Disorder medications. More than 2.5 million
children under the age of 17 use these drugs, and many adults use them as well. Today the FDA’s
Drug Safety and Risk Management Advisory Committee voted to recommend that the FDA include
its strongest “black box” warning alerting both adults and children using Attention Deficit
Hyperactivity Disorder medications of possible cardiovascular side effects. Grassley made the
following comment on today’s development.

“Today’s unexpected action shows an urgency to warn consumers of safety risks with these
medicines. It’s a surprising turn of events for a meeting that was only supposed to consider how to
further study the risks of these drugs. It’ll be interesting to see whether the FDA will act on the
committee's recommendations.”