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MEDICAL: DISEASES: MENENGITIS :
MEDICAL: PHARMACY PHARMACEUTICAL PHARMACOLOGY: DRUG: ADVERSE EVENT :
MEDICAL: PHARMACY PHARMACEUTICAL PHARMACOLOGY: DRUG:
GOVERNMENT OVERSIGHT:
Meningitis Outbreak Stirs Calls for FDA Pharmacy Oversight
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Meningitis Outbreak Stirs Calls for FDA Pharmacy Oversight
By David Morgan and Sharon Begley
WASHINGTON / NEW YORK
Tuesday October 9, 2012 1:21am EDT
Reuters
http://www.reuters.com/article/2012/10/09/
us-usa-health-meningitis-regulation-idUSBRE89804K20121009
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A shorter URL for the above link:
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http://tinyurl.com/9tggoe9
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(Reuters) - A deadly U.S. meningitis outbreak tied to contaminated steroid
shots should spur new legislation to regulate how pharmacies mix and dose
drugs, experts said on Monday.
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Health officials reported eight deaths and 105 cases of fungal meningitis
stemming from compounded versions of a steroid injection used largely to
treat back pain. They estimated that as many as 13,000 people in 23 U.S.
states may have been exposed to the drugs.
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The source of the tainted drugs, the New England Compounding Center Inc in
Framingham, Mass., is one of thousands of pharmacies that repackage or
recombine medications on a sizable scale, sometimes for off-label use by
thousands of patients.
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They operate in a legal limbo created by existing laws and federal court
rulings that have effectively blocked the regulatory powers of the Food
and Drug Administration, despite repeated threats to public health in the
last decade.
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Democratic lawmakers said the new crisis showed it was time for Congress
to strengthen the FDA's hand in overseeing this side of the drug industry.
There was no immediate comment from Republican members of Congress, who
tend to favor deregulation.
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Pending legal cases may land the issue at the steps of the Supreme Court.
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"These compounding pharmacies are operating now on a scale where
(regulation) should be a priority," said Senator Richard Blumenthal, a
member of the Senate Health, Education, Labor and Pensions Committee, who
is urging hearings and an investigation in prelude to new legislation.
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His concerns were echoed by U.S. Representative Edward Markey, another
Democrat who sent a letter to the FDA asking whether agency rules ensure
that compounded drugs meet the same safety standards as the products of
major drug manufacturers.
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The complete article may be read at the URL above.
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