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Food and Drug Administration Amendments Act of 2007

Date: Sept. 19, 2007
Location: Washington, DC
Issues: Agriculture and Food Drugs


FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 -- (House of Representatives - September 19, 2007)

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Ms. SCHAKOWSKY. Mr. Speaker, I want to thank Chairman Dingell and Chairman PALLONE, Mr. Waxman and Mr. Markey and Congresswoman Eshoo and all my colleagues on both sides of the aisle and their hardworking staffs for bringing this landmark bill to the floor today.

This bill strikes to the heart of some of FDA's most troubling issues by granting additional authorities to the Food and Drug Administration that are critical to enhancing drug safety. This bill gives consumers a larger role in deciding how user fees are spent to enhance drug safety, a huge victory for consumer protection. 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 health care.

I am particularly pleased by the inclusion of an amendment I offered that will improve consumer's 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 bad effects signal to FDA when prescription drugs pose a threat. The success of this program is crucial to postmarketing 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 also requires the 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. So, again, I thank the chairman and staff for working with me to include this language.

This bill makes a strong statement about the importance of protecting 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 toward a safer, more transparent Food and Drug Administration.

Mr. Speaker, I urge all my colleagues to support it.

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