House OKs overhaul of drug safety system

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.

Vioxx, an anti-inflammatory drug for arthritis and other types of pain, was withdrawn voluntarily by its manufacturer after five years on the market. That action came when a clinical trial testing its efficacy in preventing colon polyps indicated an increased risk of heart attack and stroke.

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. The FDA currently relies on anecdotal reports submitted by doctors and drug companies, which are believed to capture only a small fraction of bad drug reactions.

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.

The House bill also includes stiffer fines for drug companies that violate FDA requirements and tighter rules to reduce conflicts of interest among outside scientists who advise the agency.

A House-Senate conference committee will work out differences in the two bills. Congressional leaders say they want to send Bush a final version later this summer.

It’s unclear how the White House will react to the finished product.