05.09.07

Burr Applauds Senate Passage of FDA Reform Legislation

Bill would improve post-approval drug safety

U.S. Senator Richard Burr today applauded the Senate passage of S.1082, the Food and Drug Administration Revitalization Act of 2007. The legislation included language from the Safer DATA Act, which was introduced by Senators Gregg, Coburn, and Burr. The bill would require the Food and Drug Administration (FDA) to develop an active surveillance system that would monitor drug utilization and adverse events after a drug has been approved by the FDA. This legislation would also require the FDA to create a "one-stop-shop" web-based portal for drug safety information on FDA-approved drugs.

The federal government's commitment to drug safety should not end when a drug is approved by the FDA," Burr said. "This act will ensure that doctors, pharmacists, and patients have the tools they need to prevent bad drug interactions and to report safety concerns that were unknown at the time a drug was initially approved."

The government currently operates several web sites with drug safety information. This bill would consolidate all data into one web portal. The portal will include links to non-FDA web sites featuring drug safety information from medical journals and effectiveness studies like the ones conducted by Duke University's Centers for Education and Research on Therapeutics (CERTs). The CERTs program conducts post-market research to optimize the effectiveness and safety of drugs and devices. The web site will also include data from the new active surveillance system, which will provide doctors, pharmacists, and consumers with important information about drug side effects.

This bill represents the most comprehensive reform of the FDA since the Food and Drug Administration Regulatory Modernization Act of 1997 (P.L. 105-115). Burr was the sponsor of that legislation in the U.S. House of Representatives.