House gives OK to drug safety bill

The Baltimore Sun

WASHINGTON -- The House overwhelmingly approved a measure yesterday that would take significant steps to strengthen the nation's drug safety system.

It would expand the government's authority to monitor drugs for dangerous side effects and warn of potential harms after the drugs go on sale.

Democratic Rep. John D. Dingell of Michigan, chairman of the House Energy and Commerce Committee, said the legislation contained "much-needed reforms."

The House vote ratified a compromise by House and Senate negotiators after months of negotiations over details of the 422-page bill.

The Senate is scheduled to consider the measure today, and President Bush is expected to sign it.

The new law would give the Food and Drug Administration greater authority over drug companies, including requiring them to study how new drugs perform after they have been approved by the agency. Many companies fail to follow through on the studies.

The FDA also would have the authority to require quick changes to drug labels after new safety information emerges - for example, if there are signs that a drug increases the risk for stroke or other serious side effects.

"That's got to save a lot of lives in the long run," said Bill Vaughan, a senior policy analyst at Consumers Union, who expressed strong support for the legislation. "We don't get these kinds of votes every day."

Many doctors, scientists and consumer groups have clamored for changes since the popular painkiller Vioxx was linked to patient deaths in 2004.

Surveys, including one that American University is releasing today, show that the FDA gets low marks from a significant segment of the public.

Celia Wexler, Washington representative for scientific integrity at the Union of Concerned Scientists, said the legislation made improvements but won't do enough to address a major concern: conflicts of interest among the panels of experts who advise the FDA on drug approvals and label changes.

The legislation would require the FDA to grant 5 percent fewer waivers to conflicted panelists each year, rather than eliminating waivers altogether or allowing just one panelist with industry ties.

"What we've got is a very incremental formula," Wexler said.

If Congress fails to pass the drug safety legislation soon, the agency will be forced to lay off up to 2,000 FDA drug reviewers, many in Maryland. A key provision of the new law would allow the FDA to continue to charge drug makers for the review of new drugs.

The user fees, which would amount to nearly $400 million in fiscal year 2008, would help pay the salaries of FDA drug reviewers. The FDA's authority to impose the fees expires at the end of this month.

"I hope the Senate will move forthwith to approve the bill in order to avoid jeopardizing the jobs of the employees responsible for implementing these critical programs," said House Majority Leader Steny H. Hoyer of Maryland.

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