Schakowsky Heralds the Passage of the Food and Drug Safety Act of 2007

SCHAKOWSKY HERALDS THE PASSAGE OF THE
FOOD AND DRUG SAFETY ACT OF 2007

Washington, D.C.–U.S. Representative Jan Schakowsky (D-IL), a member of the House Committee on Energy and Commerce, voted in support of the Food and Drug Safety Act of 2007, which passed the House today by a vote of 405 to 7. The Act included an amendment offered by Congresswoman Schakowsky to improve consumers' awareness of the MedWatch Program. The amendment requires that printed prescription drug ads include information on how to report side effects to the FDA's MedWatch program both on the internet and through a 1-800 number. Schakowsky's amendment passed the House Energy and Commerce Committee with unanimous support on July 26, 2007.

Congresswoman Schakowsky delivered the following statement on the House floor in support of the Food and Drug Safety Act of 2007.

"Madame Speaker, I want to thank Chairmen Dingell and Pallone, as well as their hardworking staff, for their tireless work in bringing this legislation to the floor today.

This bill strikes at the heart of some of FDA's most troubling issues by granting additional authorities to FDA that are critical to enhancing drug safety. This bill also improves transparency in the user fee negotiation process — a huge victory for consumer protection. Additionally, it will take steps to enhance the kind of information that will be available to patients and their families as they make personal decisions regarding their healthcare.

I am particularly pleased by the inclusion of an amendment I offered that will improve consumers' awareness of the MedWatch program, one of FDA's best but least known ways of monitoring adverse drug events once a product has been approved.

Consumer reports of adverse effects signal to FDA when prescription drugs pose a threat. The success of this program is crucial to post-marketing surveillance. Unfortunately, 9 out of 10 Americans are unaware that the MedWatch program exists — yet adverse drug and device reactions account for as many as 100,000 deaths every year. My amendment requires that printed prescription drug ads include information on how to report side effects to the FDA's MedWatch program — both on the internet and through a 1-800 number.

It will also require FDA to do a study on how we can best include this important information on the TV ads that have become so pervasive — and influential — in our society. Again, I thank the Chairman and his staff for working with me to include this language.

This bill makes a strong statement about the importance of protecting the people who rely on prescription medications to get through their day and remain active members of society. I am encouraged by the steps it takes towards a safer, more transparent, FDA and I urge my colleagues to support it....