Senate Approves Landmark Drug Safety Bill

By RICARDO ALONSO-ZALDIVAR Los Angeles Times

Published: May 10, 2007

WASHINGTON - The Senate overwhelmingly approved a landmark drug safety bill Wednesday, doubling 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. It would significantly expand the Food and Drug Administration's 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," said former FDA Commissioner Mark McClellan. "It is really a new era for the FDA that will start after this law is implemented."

The Senate bill was drafted in response to highly publicized safety lapses, including the belated withdrawals of painkiller Vioxx and 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 TV commercials before they are aired.

After a week of contentious debate and an unsuccessful effort to add a provision allowing consumers to buy drugs from foreign suppliers, the Senate approved the bill 93-1. Sen. Bernard Sanders, the Vermont independent who is a strong critic of the drug industry, voted no.

The import amendment was opposed by the Bush administration and could have stalled the safety overhaul.

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. Senior House members say their main goal is to get a bill to President Bush by the summer.

The safety provisions are part of a larger bill reauthorizing industry user fees that now provide about half the funding for drug review and approval. Some consumer groups and lawmakers oppose funding the FDA through industry fees, saying it creates a conflict of interest.

Nonetheless, the funding legislation is considered "must-pass" because if Congress fails to act by the summer, the FDA could be forced to notify hundreds of senior scientists, doctors and statisticians - whose skills are in demand in private industry - that their jobs could be at risk.

The Senate bill, drafted by Edward Kennedy, D-Mass., and Michael Enzi, R-Wyo., would more than double the size of the FDA's safety office, which has a staff of about 90.

The cost of that expansion would be covered by user fees, which would rise from more than $300 million this year to $539 million in 2008 and $916 million in 2012, according to Senate staffers.

"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. ... When patients are in danger, the FDA should not have to wait to get legal opinions ... to protect health."

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 not be dismantled, but incorporated into the broader surveillance network for all new drugs.

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