Bush administration will not appeal FDA court ruling

By Advocate.com Editors

Originally published on Advocate.com December 18 2002 12:00 AM ET

The Bush administration announced Monday that it will not appeal a federal court ruling that eliminated the Food and Drug Administration's requirement for pharmaceutical companies to test new drugs in pediatric patients, but instead will support legislation that will make pediatric testing mandatory for certain medications, including those to treat HIV/AIDS, The Wall Street Journal reports. A federal judge in October struck down the FDA drug testing requirement, saying it "exceeded the FDA's statutory authority." The FDA, through the Bush administration, had until the end of this week to appeal the ruling but instead decided to pursue legislation to reinstate the testing requirements.

"The fastest and most decisive route for establishing clear authority in this area is to work with Congress," said Health and Human Services secretary Tommy Thompson. A bill attempting to make the pediatric testing regulations law has already cleared the Senate Health, Education, Labor, and Pensions Committee. A full Senate vote is expected early next year.