Washington – The House on Wednesday approved a sweeping overhaul of the nation’s drug-safety system as Congress moved swiftly to send President Bush a bill that significantly improves patient protections.
The lopsided 403-16 House vote followed Senate passage in May of similar legislation to strengthen the Food and Drug Administration’s ability to detect risky side effects of medicines already on the market. Congressional and independent inquiries conducted after the 2004 withdrawal of Vioxx found the agency’s safety office to be understaffed, ill-equipped and overwhelmed.
“This bill will lay the groundwork for restoring trust in the FDA,” said Rep. Frank Pallone, D-N.J., one of the authors of the legislation.
The safety legislation is part of a larger measure reauthorizing the collection of industry user fees that fund more than half the FDA’s budget for reviewing new drugs.
The House bill follows the same basic approach to safety as the Senate version, but consumer groups said it gives the FDA stronger regulatory powers in some areas.
Both bills would set up a computerized network to scan medical insurance and pharmacy records for patterns that could signal problems with new drugs.
Both bills would give the FDA additional leverage in dealing with drug companies. This includes greater authority to require that prescribing literature for doctors and patients reflect the latest scientific data on risks, as well as the power to order – not just request – follow-up safety studies.
