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* Lawmakers seek tighter regulation of compounding companies * Outbreak has sickened 138 people in 11 states, killed 12 * Senator Brown to return contributions from NECC owners By Tim McLaughlin and Toni Clarke
BOSTON, Oct 10 (Reuters) - A Massachusetts specialistpharmacy linked to a company at the center of a major healthscare closed temporarily on Wednesday and a state regulatorclamped down on such operations in the wake of a meningitisoutbreak that has claimed a dozen lives.
The Massachusetts Department of Public Health said AmeridoseLLC, a compounding pharmacy which shares ownership with the NewEngland Compounding Center (NECC) tied to the tainted steroidtreatments, had temporarily closed.
Massachusetts, which regulated the companies involved, alsosaid it would increase scrutiny of so-called compoundingpharmacies, which produce custom-made medications for doctors,as calls grew for a nationwide crackdown.
Since the Sept. 25 recall of three lots of a steroidproduced by NECC, 138 people have contracted meningitis and 12have died, according to the latest tally from the U.S. Centersof Disease Control and officials in 11 states where the outbreakhas spread.
Idaho reported the first case discovered in the westernUnited States. The hardest hit state is Tennessee with 44 peoplesickened with the rare disease.
The number of cases has grown rapidly as healthpractitioners contacted some 13,000 people who receivedinjections from a potentially tainted supply of steroidmedication shipped to 23 states.
Officials have expressed concern that NECC and othercompounding pharmacies may have violated laws that allow them toalter drugs based on the needs of individual patients ratherthan produce large batches of medication for sale. NECC shippedmore than 17,000 vials of the steroid methylprednisoloneacetate, used mainly for back pain.
In one week, the meningitis outbreak has developed into amajor national health scare and threatens to become a scandalover what the company was doing and who was supposed to beregulating its activities.
Congress has come under pressure to close what critics seeas a loophole in regulation that left the company linked to thetainted product largely exempt from federal regulation.
The U.S. Food and Drug Administration regulates only theingredients and their suppliers, not the compounders, which aresubject to a patchwork of state oversight.
"We urge Congress to give FDA (the Food and DrugAdministration) the authority it needs to assure these kinds ofoutbreaks do not happen again," said an official of the U.S.Department of Health and Human Services, who declined to beidentified because of ongoing investigations.
Leading members of Congress and outside critics have begunto ask why the FDA did not step in anyway.
"They dropped the ball. They either didn't follow up or havechosen to look the other way or they have chosen to putresources toward other things," said Dr. Michael Carome, ahealth expert with the advocacy group Public Citizen.
The FDA said in a statement that its "legal authority toregulate compounded drugs is complex and has been challengedvigorously by the compounding industry both in courts andCongress. FDA, along with everyone involved, is focused ondetermining the cause of this outbreak and preventing this kindof tragedy in the future."
Massachusetts officials said the state would require allcompounding pharmacies to sign a statement saying they arecomplying with regulations on their work.
Massachusetts Senator Scott Brown, a Republican, said onWednesday his re-election campaign would donate to charity thecampaign contributions received from the owners of NECC.
"Sen. Brown supports a full and thorough investigation todetermine responsibility for this tragedy and to ensure nothinglike it ever happens again," the campaign said in a statement.
ANGER FROM FAMILIES
Some patients expressed anger that such a sensitive area assteroid medication was so lightly regulated.
George Cary, whose wife Lilian Cary is one of three peopleto die in Michigan, said on Tuesday that Americans have a strongbelief in their medical and political system and the outbreakshould be a wake-up call to the nation.
"We don't have expectations of a faulty regulatory medicalsystem that allows these types of mistakes to be made," Carytold reporters on his front lawn after a memorial for his wife."So perhaps the message is, wake up America."
In five states - Tennessee, Michigan, Maryland, Virginia,and Florida - the outbreak has claimed lives, with the latestvictim a 70-year-old man in Florida.
Thousands of people received the injections to relieve backpain and other complaints and are at risk of infection.
Approximately 5 percent of patients treated with the suspectmedication in Tennessee have contracted meningitis, said Dr.David Reagan, chief medical officer for the Tennessee Departmentof Health. The rate of infection overall is not known.
Meningitis is an infection of the membranes covering thebrain and spinal cord. Symptoms include headache, fever andnausea. Fungal meningitis, unlike viral and bacterialmeningitis, is not contagious.
Some of the thousands of people exposed may have to waitanxiously for weeks because the incubation period of the diseaseis up to a month, health experts said.
In Tennessee cases, officials said they had found theaverage incubation period to be 16 days, but they caution thatit could range from six to 42 days for their patients.
Tennessee has been the hardest hit state, with six reporteddeaths and 44 cases of meningitis, followed by Michigan withthree deaths and 28 cases, Virginia with one death and 27 casesand Maryland with one death and nine cases.
The other states with cases are Indiana (15), Florida (6),Minnesota (3), North Carolina (2), Ohio (1), New Jersey (2) andIdaho (1).
(Additional reporting by David Morgan, Susan Guyett and MeghanaKeshavan; Writing by Greg McCune and Michele Gershberg; Editingby Lisa Shumaker, Claudia Parsons and David Gregorio)
Keywords: USA HEALTH/MENINGITIS