Congress moves to improve drug safety, patient protection

The Baltimore Sun

WASHINGTON -- The House approved a sweeping overhaul of the nation's drug safety system yesterday, 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.

"Over the past few years, it has become clear that consumers have been placed in harm's way because of the failings of the public health system," said Rep. Frank Pallone Jr., a New Jersey Democrat and author of the legislation. "This bill will lay the groundwork for restoring trust in the FDA."

Vioxx, an anti-inflammatory drug for arthritis and other types of pain, was withdrawn voluntarily by its manufacturer after five years on the market.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 safety legislation approved yesterday 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 some stronger regulatory powers.

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

A computerized system could take several years to put in place, and while the Senate bill sets some progress benchmarks for the FDA to meet, the House version does not.

Both bills would give the FDA additional leverage in dealing with drug companies: 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.

Such oversight would be carried out through risk management plans individually tailored to specific drugs. The rules for the risk plans are complex, but policy analyst William Vaughn of Consumers Union said that, overall, the House approach appears to be stronger. It's unclear how the White House will react to the finished product.

Ricardo Alonso-Zaldivar writes for the Los Angeles Times.

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