Drug Safety
The Food and Drug Administration (FDA) is charged with ensuring the safety of drugs in the U.S. The FDA plays the important role of approving drugs based on the results of clinical trials as well as monitoring and gathering data to ensure to determine if any adverse drugs reactions have become apparent after the drugs enter the marketplace. The FDA developed MedWatch to provide important safety information to consumers and to allow consumers to report serious problems with human medical products. For the best outcomes, consumers must be informed about this MedWatch system so that they can learn important safety information on the drugs that they take and how to report adverse reactions to prescription drugs. As part of the passage of the Food and Drug Safety Act of 2007, I worked to include a requirement that will improve consumers' awareness of the MedWatch Program. My amendment, which was incorporated into the law, 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 toll-free number. The FDA was also required to study how we can best include this important information in TV ads for prescription medications.
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