June 12, 2007 - MARKEY STATEMENT ON FDA REFORM DISCUSSION BILLS

Statement of Edward J. Markey
At the Health Subcommittee Hearing on FDA Discussion Drafts
June 12, 2007

Thank you, Mr. Chairman for allowing me to participate in today’s hearing and thank you for your leadership on these important issues.

Today, the Energy and Commerce committee is considering a package of FDA bills that includes the Markey-Rogers pediatric devices bill to encourage development of safer device for kids and the drug safety bill that I co-authored with my friend, Congressman Waxman to strengthen and reform the FDA.

Over the past few years, we have learned about serious problems with drugs too late and the FDA has acted too slowly to protect the public health.

As a result, thousands of families have lost loved ones to the dangerous side effects of unsafe drugs.

The FDA’s system failed their families and we owe it to them and the millions of Americans that rely on medications every day to learn from these experiences and fix our broken system.

The Waxman-Markey bill responds to the lessons learned from Vioxx, Ketek, Paxil and Avandia and through the Risk Evaluation Mitigation Strategy (REMS) puts in place a strong post-market safety net to identify safety problems early and address them quickly.

Our bill also creates a mandatory registry of clinical trials so that drug companies can’t pick and choose which trial results they want to make public and which trial results they don’t want you to see.

Within the next two weeks, I hope to work with my colleagues to further build on and strengthen these proposals and pass a robust, comprehensive FDA reform package out of this committee.