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US House Democrats call for probe of meningitis outbreak

Tuesday, 9 Oct 2012 | 1:53 PM ET

WASHINGTON, Oct 9 (Reuters) - Democrats in the U.S. House of Representatives called on Tuesday for a congressional probe of a deadly meningitis outbreak tied to tainted medicine that may have exposed 13,000 people to danger.

In a letter to the Republican chairman of the House Energy and Commerce Committee, three lawmakers also called for hearings to determine whether a lack of clarity surrounding the U.S. Food and Drug Administration's authority over the pharmacy that compounded and distributed the drug delayed efforts to identify the source of the outbreak.

"This incident raises serious concerns about the scope of the practice of pharmacy compounding in the United States and the current patchwork of federal and state laws," said the letter co-authored by the panel's top Democrat Henry Waxman and fellow members, representatives Frank Pallone and Diana DeGette.

Republican committee chairman Fred Upton was not immediately available for comment.

Meanwhile, in the Senate, the Democratic chairman and ranking Republican on the Health, Education, Labor and Pensions Committee requested a briefing on the outbreak from FDA and U.S. Centers for Disease Control and Prevention staff.

A Senate Democratic aide said the briefing would help Democrat Tom Harkin and Republican Mike Enzi determine what congressional action, if any, the outbreak might merit.

The outbreak, traced to steroid treatments for back and joint paint produced by a Massachusetts pharmacy, has spread to 119 patients in nine states, 11 of whom have died.

The cases have put the spotlight on a little-known segment of the pharmacy practice known as drug-compounding, which occurs when pharmacists alter or recombine FDA-approved drugs produced by manufacturers.

Drug compounders are regulated mainly by state pharmacy boards and not subject to FDA safety and efficacy standards for manufacturers.

House Democrats said the company in Massachusetts, New England Compounding Center, appeared to be operating as a drug manufacturer when it shipped more than 17,000 vials of injectible steroids to 76 facilities located in 23 states.

The letter recommended that congressional staff investigate to determine the extent to which Massachusetts authorities acted to maintain safety at NECC facilities.

The Democrats also listed a host of other questions including whether there were legitimate scientific reasons for using the steroid treatment and if patients and doctors were aware that the products were produced by compounding.

(Reporting by David Morgan; Editing by Claudia Parsons)

((david.morgan@thomsonreuters.com)(+1)(202)(898 8326)())

Keywords: USA HEALTH/MENINGITIS CONGRESS