UPDATE 2-US House Democrats call for probe of meningitis outbreak

* House, Senate lawmakers seek meningitis briefings

* Briefings may lead to new action on drug safety

(Adds House request for FDA, CDC briefings)

By David Morgan

WASHINGTON, Oct 9 (Reuters) - Leading lawmakers from theU.S. House of Representatives and the Senate on Tuesday askedfederal health officials for briefings on a deadly meningitisoutbreak in nine states as a first step toward possiblelegislative action to strengthen federal drug safetyregulations.

Aides said the bipartisan leaders of oversight committees inboth chambers hoped to learn more about the spreading outbreakbefore Oct. 12 from staff members of the Food and DrugAdministration and the Centers for Disease Control andPrevention, which warns that as many as 13,000 people may havebeen exposed to the fungal meningitis pathogen through taintedsteroid treatments.

The requests are a sign of growing congressional concernabout the outbreak that has killed 11 people and 119 as a resultof contaminated injections for back and joint pain produced by aFramingham, Massachusetts-based pharmacy through a lightlyregulated practice known as drug compounding.

Drugs are compounded when a pharmacy alters or recombinesapproved medication to meet the special needs of doctors andtheir patients.

"We intend to learn more from the FDA, CDC, and others whomay provide insight into the details surrounding this outbreakand the prevention of future outbreaks," Representative FredUpton, Republican chairman of the House Energy and CommerceCommittee, said in a letter to the two agencies coauthored bythree Republicans and two Democrats from the panel.

"The committee has a long bipartisan history of conductingdrug safety oversight and is very concerned about these recentdevelopments," they wrote.

Earlier in the day, Democratic Senate aides said theagencies were sent a similar request from Senator Tom Harkin,chairman of the Senate Health, Education, Labor and PensionsCommittee, and the panel's ranking Republican, Senator MikeEnzi.

An FDA spokeswoman said the regulatory agency would respondpromptly to the lawmakers' requests. CDC officials were notimmediately available for comment.

Democratic lawmakers from both chambers have already calledfor an investigation into the outbreak and hearings as a preludeto possible legislation that could bring large-scale compoundingpharmacies firmly under FDA scrutiny.

In a letter to Upton, three Democrats questioned whetherefforts to identify the source of the outbreak were delayed byconfusion surrounding the U.S. Food and Drug Administration'sauthority over compounding pharmacies.

"This incident raises serious concerns about the scope ofthe practice of pharmacy compounding in the United States andthe current patchwork of federal and state laws," wrote thepanel's top Democrat, Representative Henry Waxman, who wasjoined by fellow members Frank Pallone and Diana DeGette.

Waxman and Pallone later joined their Republican colleaguesto request the FDA and CDC briefing.

A fourth Democrat, Edward Markey, whose Massachusettsdistrict includes Framingham, said separately that he wouldintroduce legislation to strengthen the FDA's regulatoryauthority.

Democratic Senator Richard Blumenthal has called for ameningitis investigation by Harkin's committee, saying newlegislation is needed.

The three House Democrats said the pharmacy at the center ofthe outbreak, the New England Compounding Center, appeared tostray far beyond a legal exemption for pharmacists that allowsthem to provide customized doses of medicine to individualpatients.

Instead the lawmakers said NECC operated like amanufacturer, shipping more than 17,000 vials of compoundedsteroid injections to customers at 76 facilities in 23 states.

"Congress ... did not intend for a compounding pharmacy tobe permitted to operate as a small drug manufacturer," thelawmakers wrote.

Compounding is not subject to the safety and efficacystandards that FDA requires of drug manufacturers. Legal andpublic health experts say that creates a regulatory loophole foroperators seeking to boost profits by compounding large volumesof drugs at prices far below those of FDA-approved products soldby manufacturers.

The regulatory question is also at the heart of conflictingfederal court rulings on the FDA's ability to scrutinizecompounding pharmacies. Experts say the cases pose issues thatmay need to be settled by the U.S. Supreme Court.

The Democrats asked whether the FDA knew of the scope ofNECC operations and whether the agency had clear authority toact.

They also raised questions about whether Massachusettshealth officials took steps to ensure the safety of NECCproducts following earlier problems addressed by a 2006 consentagreement.

According to the letter, Congressional officials should alsodetermine if there were legitimate scientific reasons for usingthe steroid treatment and whether patients and doctors wereaware that the products were produced by compounding.

(Reporting by David Morgan; Editing by Michele Gershberg,Claudia Parsons and Prudence Crowther)

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Keywords: USA HEALTH/MENINGITIS CONGRESS