Senate votes to double attack on risky drugs

WASHINGTON -- The Senate overwhelmingly approved a landmark drug-safety bill Wednesday that would double the number of government scientists assigned to ferret out risky side effects in medicines already on the market.

The bill also would create a computerized network to scan medical-insurance and pharmacy records for signs of trouble with new drugs and expand the Food and Drug Administration's (FDA) power to require drug makers to reduce risks.

"This is unquestionably the biggest change in the FDA's regulatory authority in a very long time," former FDA Commissioner Mark McClellan said.

The Senate bill was drafted in response to highly publicized safety lapses, including the belated withdrawals of the painkiller Vioxx and the diabetes drug Rezulin, as well as the FDA's tardy warning about the suicide risks of antidepressants. A tougher version is expected to emerge from the House in coming weeks.

The Senate bill also responds to consumer complaints about misleading drug advertising by setting up a voluntary program through which the FDA would review television commercials before they air.

After a week of debate and an unsuccessful effort to add a provision allowing consumers to buy drugs from foreign suppliers, the Senate approved the bill 93-1. The import amendment was opposed by the Bush administration and could have stalled the safety overhaul.

Sen. Bernard Sanders, the Vermont independent who is a strong critic of the drug industry, cast the only vote against the bill.

Drug-safety bill

The legislation passed by the Senate would:

• Create a computerized system to monitor potential problems with new drugs.

• Give the Food and Drug Administration stronger legal powers to require follow-up safety studies and stronger warnings for medications already on the market.

• Provide significant increases in funds and staff for the FDA drug-safety office.

• Expand public disclosure of clinical trials and their results.

• Require the FDA to release dissenting opinions of agency scientists.

• Impose stricter conflict-of-interest rules for FDA outside advisers.

Los Angeles Times

The House is expected to begin writing its own version of the legislation soon. Its approach is expected to be tougher on industry, but senior House lawmakers have praised the Senate's basic approach and say their main goal is to get a bill to President Bush by summer.

The safety provisions are part of a larger bill reauthorizing industry user fees that now provide about half the funds for drug review and approval.

The Senate bill, drafted by Sens. Edward Kennedy, D-Mass., and Mike Enzi, R-Wyo., would more than double the size of the FDA's safety office, which now has a staff of about 90. The cost of that expansion would be covered by user fees, which would rise from a total of more than $300 million this year to $539 million in 2008 and $916 million in 2012, according to Senate staff members.

"This legislation [will] bring the Food and Drug Administration into the 21st century," Kennedy said. "It greatly improves the way the FDA oversees the safety of drugs."

With nearly half of adults regularly taking some kind of prescription medication, the risk of dangerous side effects has become a much bigger concern in recent years.

A core weakness of the current system is that new drugs are tested on no more than a few thousand people before approval, and rare side effects may not emerge until many more patients have used a medication. Some prominent medical experts think all new drugs should be considered experimental for at least two or three years after approval.

The computerized surveillance system outlined in the bill would provide a way to keep closer tabs on newly approved drugs.

That would be a major step forward for the FDA, which relies on an antiquated system based on anecdotal reports from doctors and picks up only a small fraction of adverse reactions. The current reporting system would be incorporated into the broader surveillance network for all new drugs.

"The legislation allows for routine, active safety monitoring using large linked databases," Enzi said.

The network would be designed to scan millions of records in billing files from government health-care programs and private insurers. Patients' identities would be protected, because the system would be designed not to ferret out personal information but to detect broad patterns of problems.

The system would raise a red flag, for example, if billing records indicated that arthritis patients given a new painkiller were more likely later on to get treated for heart trouble than similar patients taking an older drug. Precisely such a research finding from a large HMO's database provided the initial unheeded warnings about Vioxx.

The bill also would give the FDA new legal powers in dealing with drug companies. Regulators would be able to order additional safety studies of approved drugs and would have more leverage to impose warnings and change prescribing instructions for doctors.

The new powers would be used to craft an individual risk-management plan for any drug thought to pose a significant danger. Pharmaceutical companies that violate the risk plans could face fines of up to $2 million.

The industry has raised concerns about the proposed risk plans, but after the vote the Pharmaceutical Research and Manufacturers of America issued a statement saying the bill "will no doubt make a good system even better."

The bill also contains provisions to reduce secrecy in the drug-development process by requiring public disclosure of most clinical trials and the release of memos that reflect internal FDA dissent about medications being considered for approval.