UPDATE 1-US House Democrats call for probe of meningitis outbreak

* House Democrats seek probe but Republican chairman mum

* Massachusetts lawmaker pledges bill to strengthen FDA

* Senators request briefing with FDA, CDC staff

(Adds details on lawmaker queries throughout)

By David Morgan

WASHINGTON, Oct 9 (Reuters) - Congressional Democrats onTuesday called for a probe of a deadly meningitis outbreak innine states, raising questions on issues ranging from the timingof the official response to the possible role of health insurersincluding Medicare.

The outbreak, which may have exposed as many as 13,000people to tainted steroid injections for back and joint pain,could pose a challenge for Congress in the partisan pre-electionatmosphere and as it faces a post-ballot fight over healthcarespending in deficit-reduction talks.

Lawmakers in both the House of Representatives and theSenate appear to be moving slowly on the issue so far.

At the center of the crisis is a Framingham,Massachusetts-based pharmacy involved in the largely unregulatedpractice of drug compounding, or altering approved medicines tomeet the special needs of doctors and their patients. Healthofficials said on Tuesday that 11 people had died and 119 hadbeen sickened by the contaminated drugs.

In a letter to the Republican chairman of the House Energyand Commerce Committee, 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.

They also expressed concern that some healthcare providersmay have purchased the tainted treatments at a low price andthen received full compensation from private health insurers andMedicare, the government healthcare program for the elderly anddisabled.

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

The office of the House oversight committee's Republicanchairman, Fred Upton, did not return phone calls or emailsseeking comment.


Democratic Senator Richard Blumenthal has called for ameningitis investigation by the Senate Health, Education, Laborand Pensions Committee, saying new legislation is needed.

That panel's Democratic chairman and Republican rankingmember have instead requested a briefing with the staff from FDAand the U.S. Centers for Disease Control to determine whataction, if any, Congress should take.

One Republican, Senator Richard Burr, issued a statement onTuesday acknowledging that the outbreak raises importantregulatory questions. But he stopped short of Blumenthal's callfor a Senate probe and official hearings.

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)

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