Appropriations Committee Accepts DeLauro Amendment, Gives FDA Authority to Mandate Postmarket Studies
Appropriations Committee Accepts DeLauro Amendment, Gives FDA Authority to Mandate Postmarket Studies
- New GAO study says Congress should give agency the authority-
Congresswoman Rosa L. DeLauro (Conn.-3) today offered an amendment during the House Appropriations Committee's consideration of the Fiscal Year 2007 Agriculture Appropriations bill to give the Food and Drug Administration (FDA) the authority to mandate postmarket studies of prescription drugs when needed. 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. The committee agreed to the amendment and the language is now part of the bill.
DeLauro is ranking member of the House Appropriations Agriculture Subcommittee.
"Giving FDA the authority to mandate postmarket drug studies is a critical part of the drug safety process. But currently, FDA does not have that legal authority," said DeLauro. "No one is accusing the FDA of willful negligence. But the fact is, these studies need to be done - and according to GAO's report, experts in the field believe FDA needs to this authority to ensure that we are not putting lives at risk with unsafe, untested drugs."
A similar amendment was offered in the full-committee mark-up last year that received bipartisan support. Since that time, however, 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 decision-making responsibility, and that ODS officials sometimes felt that their recommendations fall, quote "into a black hole or abyss" at the agency.
"At a time when 65 percent of post-market studies are pendingwhen 14 months passed before the label on Vioxx even changedit is clear that the system FDA has in place is still broken and must be fixed," said DeLauro. "The problems plaguing this agency far exceed anything that can be fine tuned in the system. FDA lacks the authority to mandate a postmarket study and this amendment gives them that authority."
DeLauro's amendment also calls on FDA to begin proceedings on removing a drug from the market if a drug company refuses to carry out the agreed to postmarket study. Since 2000, 10 drugs have been withdrawn for safety reasons by their manufacturers - all voluntarily.
http://www.house.gov/delauro/press/2006/May/FDA_amendment_5_9_06.html