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Monday, 29 October 2012

U.S. regulator needs new authority over compounding pharmacies: report




The U.S. Food and Drug Administration's power to regulate compounded drugs similar to those linked to a deadly meningitis outbreak is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers, according to a congressional report released on Sunday.

The report, compiled by the staff of U.S. Representative Edward Markey, a Massachusetts Democrat, drew an immediate response from FDA Commissioner Margaret Hamburg, who said the agency is committed to working with Congress and others to garner "the authority we need to help prevent tragedies like this from happening again."

"Over the years, there has been substantial debate within Congress about the appropriate amount of FDA oversight and regulation of compounding pharmacies. But unfortunately, there has been a lack of consensus and many challenges from industry," Hamburg said in a statement emailed to Reuters.

"As pointed out in the report from Congressman Markey, FDA's authority over compounding pharmacies is more limited by statute than with drug manufacturers," she added.

The Markey report and Hamburg's comments surfaced as Congress has begun preliminary discussions that could give the FDA new powers to oversee compounding pharmacies like the New England Compounding Center, which is at the heart of a fungal meningitis outbreak that has sickened 337 people, including 25 who have died, in 18 states.

But the public health crisis has also stirred debate about how much authority the FDA actually needs. Last week, the advocacy group Public Citizen called on the Department of Health and Human Services to investigate the agency on grounds that it failed to exercise its existing authority to prevent the meningitis outbreak.

29/10/2012  :  David Morgan / Reuters.

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