Healthy Skepticism Library item: 11538

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Publication type: news

Blum J.
Drug Safety Measure Clears Congress, Goes to Bush
Bloomberg News 2007 Sep 21
http://www.bloomberg.com/apps/news?pid=20601202&sid=a.xzwPdQe_Zs&refer=healthcare

Full text:

Congress sent President George W. Bush legislation providing the U.S. government with more power to police the safety of prescription drugs, a measure that drew almost unanimous support from lawmakers.

The legislation, given final approval in the Senate yesterday, grants the Food and Drug Administration authority to make pharmaceutical companies study the safety of their products after they go on the market. Regulators also could order that warnings be added to prescribing information.

The safety changes are a response to the FDA’s failure to act effectively when harmful side effects have been identified in medications, lawmakers said. The agency’s performance has been questioned in handling Vioxx, the Merck & Co. drug withdrawn in 2004 after being linked to heart attacks and strokes, and Avandia, GlaxoSmithKline Plc’s diabetes pill linked in some studies to a risk of heart attacks.

The legislation ``gives the FDA authority to take swift, appropriate and decisive action to ensure patient safety and protect consumers when new information comes to light to expose unexpected risks,’‘ said Senator Michael Enzi, a Republican from Wyoming, in a statement.

The Senate cleared the legislation by unanimous consent a day after the House passed it by a vote of 405-7. Negotiators had resolved differences between separate measures passed by the chambers in previous votes.

Bush is ``likely’‘ to sign the legislation, spokeswoman Emily Lawrimore said. FDA Commissioner Andrew von Eschenbach said in a statement that he is pleased Congress acted.

The measure would renew and increase fees paid to the FDA by makers of drugs and medical devices to speed regulatory review. Without new legislation, the fees would expire at the end of this month.

Dismissal Notices

Von Eschenbach had said that if legislation including the fees wasn’t approved by today, his agency would have to send dismissal notices to 2,000 of its 10,000 employees.

Drugmakers supported the legislation.

``We’re really happy with it,’‘ said Dolly Judge, a senior lobbyist for New York-based Pfizer Inc., in an interview. The measure should ``restore confidence’‘ in the FDA’s oversight of drug safety by giving the agency more power, Judge said.

Some consumer groups, such as Consumers Union, based in Yonkers, New York, said the measure would improve safety. Others said Congress didn’t go far enough.

``The essential problems in drug safety remain unaddressed,’‘ said Peter Lurie, deputy director of the Health Research Group at Washington-based Public Citizen, an advocacy organization, in an interview. ``It’s an enormous lost opportunity.’‘

Fees’ Influence

Fees paid by drugmakers should have been eliminated because they influence FDA decision-making, Lurie said. Lawmakers also should have created an independent drug safety division within the FDA because its safety scientists are often overruled when they want to act on harmful side effects, he said.

The legislation would encourage the agency to pay more attention to dangers discovered after approval of a drug, lawmakers said. While drugmakers must complete clinical trials before regulators approve products, harmful side effects often aren’t detected until treatments are more widely used.

Currently, the FDA can only request that drugmakers conduct added studies after drugs are sold. Also, the agency can ask, not mandate, that companies add warnings to package inserts.

Drugmaker Fines

Under the legislation, companies that violate FDA orders on labels and studies or certain other requirements could be fined as much as $250,000 for a single violation and $10 million for multiple failings handled in one proceeding.

The legislation calls on the FDA to use databases, such as those maintained by insurance companies, to detect side effects suffered after medications come on the market.

Results of clinical trials would have to be disclosed, which supporters of the legislation said would make it harder for drugmakers to withhold evidence of dangers.

Estimated fees paid by drugmakers to the FDA would increase to $417.8 million for the fiscal year beginning Oct. 1, up from at least $305.5 million in the current year. Some of the new funds would pay for drug safety.

Drugmakers also would pay new fees when they voluntarily submit consumer advertisements to the FDA for review. The agency would use the fees to hire additional staff to speed reviews.

The legislation would renew a program that gives drugmakers an added six months of protection from competition if they perform FDA-requested studies of how products work in children. The compromise legislation doesn’t include a Senate provision that would have reduced the period to three months for drugs with more than $1 billion in annual sales.

Trial Lawyers

The measure includes language backed by trial lawyers that could make it harder for drugmakers to win lawsuits filed by people who say they’ve been injured by medications. The legislation says companies are responsible for disclosing risks on package labeling. Enzi complained the provision was included in the legislation without debate.

Companies have argued they’re not at fault when the FDA had found new warnings weren’t needed. Language sought by some Republicans, which would have helped the companies make that case, wasn’t included in the measure.

To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net .