WASHINGTON, Oct 9 (Reuters) - Democrats in the U.S. House ofRepresentatives called on Tuesday for a congressional probe of adeadly meningitis outbreak tied to tainted medicine that mayhave exposed 13,000 people to danger.
In a letter to the Republican chairman of the House Energyand Commerce Committee, three lawmakers also called for hearingsto determine whether a lack of clarity surrounding the U.S. Foodand Drug Administration's authority over the pharmacy thatcompounded and distributed the drug delayed efforts to identifythe source of the outbreak.
"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," said theletter co-authored by the panel's top Democrat Henry Waxman andfellow members, representatives Frank Pallone and Diana DeGette.
Republican committee chairman Fred Upton was not immediatelyavailable for comment.
Meanwhile, in the Senate, the Democratic chairman andranking Republican on the Health, Education, Labor and PensionsCommittee 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 helpDemocrat Tom Harkin and Republican Mike Enzi determine whatcongressional action, if any, the outbreak might merit.
The outbreak, traced to steroid treatments for back andjoint paint produced by a Massachusetts pharmacy, has spread to119 patients in nine states, 11 of whom have died.
The cases have put the spotlight on a little-known segmentof the pharmacy practice known as drug-compounding, which occurswhen pharmacists alter or recombine FDA-approved drugs producedby manufacturers.
Drug compounders are regulated mainly by state pharmacyboards and not subject to FDA safety and efficacy standards formanufacturers.
House Democrats said the company in Massachusetts, NewEngland Compounding Center, appeared to be operating as a drugmanufacturer when it shipped more than 17,000 vials ofinjectible steroids to 76 facilities located in 23 states.
The letter recommended that congressional staff investigateto determine the extent to which Massachusetts authorities actedto maintain safety at NECC facilities.
The Democrats also listed a host of other questionsincluding whether there were legitimate scientific reasons forusing the steroid treatment and if patients and doctors wereaware that the products were produced by compounding.
(Reporting by David Morgan; Editing by Claudia Parsons)
Keywords: USA HEALTH/MENINGITIS CONGRESS