Congressional Republicans Kill Important Drug Safety Safeguard, Said DeLauro
Congressional Republicans Kill Important Drug Safety Safeguard, Said DeLauro
- Language giving FDA authority over postmarket studies stricken from legislation -
Congressional Republicans stripped an important drug safety safeguard from the Fiscal Year 2007 Agriculture Appropriations bill, Congresswoman Rosa L. DeLauro (Conn.-3) said today. During consideration of the bill in the U.S. House, language offered by DeLauro during committee consideration of the bill giving the Food and Drug Administration (FDA) the authority to mandate postmarket studies of prescription drugs was stricken from the bill. FDA lacks any real authority to order a company to conduct a safety study of a drug already on the market, even when serious safety concerns are raised.
DeLauro is the ranking member of the House Appropriations Agriculture Subcommittee.
"Weeks after the Appropriations Committee voted to give the FDA authority to mandate postmarket studies - an authority the Government Accountability Office and many consumer interest groups have argued the agency needs - Congressional Republicans stripped this authority from legislation moving through Congress," said DeLauro. "Just yesterday we learned of a new study showing patients taking Vioxx began to have cardiovascular problems after only four months of taking the medication - much sooner than the 18 months shown in initial studies. This alone is evidence of why postmarket studies are needed - this authority is a critical part of the drug safety process. This authority should have become law."
Earlier this year, the Government Accountability Office (GAO) issued a scathing report of postmarket studies, stating, "FDA lacks clear and effective processes for making decisions about, and providing management oversight of, postmarket safety issues." The report went on to say that disputes between the Office of Drug Safety and Office of New Drugs slowed the evaluation process, that ODS has no independent decisionmaking responsibility, and that ODS officials sometimes felt that their recommendations fall, quote into a black hole or abyss' at the agency.
http://www.house.gov/delauro/press/2006/May/FDA_safeguard_5_23_06.html