Drug safety overhaul passes

Times Staff Writer

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.

“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. (D-N.J.), one of the authors 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Vioxx, an anti-inflammatory drug for arthritis and other types of pain, was voluntarily withdrawn by its manufacturer after five years on the market.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 Wednesday is part of a 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 would give 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 now relies 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 deploy. The Senate bill sets some benchmarks for the FDA; the House version does not.

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 reflects the latest 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 tailored to specific drugs. The rules for the risk plans are complex, but policy analyst William Vaughan of Consumers Union said that, overall, the House approach appears to be stronger.

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 between the two bills. Congressional leaders say they want to send Bush a final version this summer.

It’s unclear how the White House will react to the finished product. Before the Senate voted in May, the administration said it agreed with the goals of the legislation but had serious concerns about aspects of the risk plans. The pharmaceutical industry, an important administration constituency, has expressed support for the Senate bill.

A potential wild card in the negotiations will be a committee-passed Senate bill that would set up a system for the FDA to approve generic versions of biologic drugs. Biologics are derived from living cells -- not chemicals -- and are considered to hold great promise. Some senators want the conference committee to incorporate the biologics bill into the final drug-safety overhaul, but the administration has said it prefers that the issue be dealt with separately.