Congress Urged to Act on US FDA Safety Reforms

posted on:
October 9, 2006

author:
Staff

WASHINGTON – Editors at a major medical journal and members of a drug-safety advisory panel joined calls for major changes to improve the U.S. Food and Drug Administration's oversight of medicines on the market.

A New England Journal of Medicine editorial urged the U.S. Congress to adopt recommendations made by an Institute of Medicine (IOM) panel last month to bolster drug safety. The IOM report pressed Congress to give the FDA more staff, funding and power — including the ability to require the drug industry to do post-approval studies and change warning labels.

We face a mounting public health crisis in drug safety, and definitive action must be taken… The IOM committee's report is a crucial starting point, the editors wrote. They also appealed for an end to "a growing politicization" of the FDA in recent years.

Concern about side effects from prescription drugs intensified after Merck & Co Inc. withdrew arthritis drug Vioxx in September 2004 because of a link to heart damage. Critics said the FDA should have reacted sooner to signs of problems related to Vioxx and other medicines on the market.

In another medical journal, five current or former members of the FDA's Drug Safety and Risk Management Advisory Committee also urged lawmakers to fix many of the problems the IOM and others identified. Along with more funding for FDA drug-safety programs, the experts from outside the agency suggested a time-limited "conditional approval" for some drugs that would require additional tests.

"It is now up to Congress to take the steps necessary to reinvigorate the FDA's ability to assure the public that approved medical products are safe," Dr. Curt Furberg and others wrote in the Archives of Internal Medicine.

Congress must pass legislation next year to renew industry fees that help fund drug reviews, and that bill could be a vehicle for addressing drug safety issues.

Furberg and his co-authors backed a plan put forth in a Senate bill for a drug safety center within the FDA that would handle post-approval tracking of side effects and be separate from pre-approval drug reviews. Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said on Monday such separation would "really exacerbate the problem" by making it more difficult for pre- and post-approval reviewers to work together.

"What we need is better science and more resources and mechanisms to improve the way that we work together," Galson said in an interview. Galson and other top FDA officials previously have said they already are taking steps to strengthen drug safety monitoring and are considering the suggestions in the IOM report, which the agency requested.

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