Senator Gregg Applauds Enactment of FDA Reform Measure

Press Release

Senator Gregg Applauds Enactment of FDA Reform Measure

Law Includes Gregg's Drug Safety Language

U.S. Senator Judd Gregg (R-NH), a member of the Senate Health, Labor, Education, and Pensions Committee, today applauded the final enactment of the Food and Drug Administration Amendments Act of 2007.

The bill, signed into law by President Bush today, includes drug safety language based on the Safer DATA Act (S. 1024) that Senator Gregg introduced earlier this year. This language puts drug safety data surveillance at the center of the FDA's efforts to monitor and improve the safety of the nation's drug supply.

"This new law helps the FDA to heighten the safety of drugs being prescribed to our citizens," said Senator Gregg. "It improves the FDA's ability to collect, manage and analyze safety data about drugs already on the market. In short, this law offers better protections for the thousands of Americans who depend on prescription medication for a better quality of life."

Senator Gregg's drug safety language requires the FDA to collaborate with academic institutions and private entities to make better use of the pooled information contained in large health-care databases, like those run by private insurers and federal health programs.

Currently, the FDA relies on a largely passive approach to monitor of drug-safety issues, and many experts, including the Institute of Medicine, have called for a more comprehensive approach to improve the existing tools for adverse event reporting to enable systematic post-market surveillance.

Former FDA Commissioner Mark McClellan today said, "I commend Senator Gregg for ensuring that the FDA has the new tools and authority it needs to conduct active surveillance of drug safety, a much needed step to increase the benefits and reduce the risks of prescription medicines."

The legislation also creates a comprehensive web-based portal for drug safety information on FDA-approved drugs on the market.

Friends of Cancer Research founder and chairperson Ellen Sigal today praised the inclusion of Senator Gregg's Safer DATA language, saying, "It gives great hope for all patients. They will have more immediate access to information about cutting-edge treatments, and will know that the FDA now has the technology to continue to look out for them long into their treatment and recovery."

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