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Congress to Open Hearings Into Steroid/Meningitis Outbreak
Date:11/13/2012

By Steven Reinberg and Margaret Steele
HealthDay Reporters

TUESDAY, Nov. 13 (HealthDay News) -- Congress will open hearings this week into the fungal meningitis outbreak linked to tainted steroid injections that has killed 32 people so far and sickened 438 others.

On Wednesday, a subcommittee of the House Committee on Energy and Commerce will hold a hearing titled "The Fungal Meningitis Outbreak: Could It Have Been Prevented?"

And on Thursday, U.S. Food and Drug Administration Commissioner Margaret Hamburg is scheduled to testify before the Senate Committee on Health, Education, Labor, and Pensions for a hearing, "Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak."

A Massachusetts specialty -- or "compounding" -- pharmacy is the suspected source of the tainted steroid injections, which are typically used for back and joint pain. The New England Compounding Center, in Framingham, has ceased operations since the meningitis outbreak first surfaced last month.

Compounding pharmacies combine, mix or alter ingredients to create drugs to meet the specific needs of individual patients, according to the FDA. Such custom-made drugs are frequently required to fill special needs, such as a smaller dose, or the removal of an ingredient that might trigger an allergy in a patient.

Compounding pharmacies aren't subject to the same FDA oversight as regular drug manufacturers. But some members of Congress now say the meningitis outbreak underscores the need for more regulatory control.

Meningitis is inflammation of the lining surrounding the brain and spinal cord. Infected patients have developed a range of symptoms approximately one to four weeks following their injection.

Massachusetts officials said earlier this month they had put emergency regulations in place that give the state greater control and scrutiny over specialty pharmacies like the New England Compounding Center.

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