Posted by Miranda S. MillerOctober 18, 2012 1:29 PM
Following in the footsteps of U.S. Senators Bob Corker and Lamar Alexander of Tennessee, Michigan Representative John D. Dingell has written a letter to the FDA regarding the NECC fungal meningitis outbreak. Tennessee’s health department has confirmed 61 fungal meningitis cases and eight deaths, newschannel5.com reported Thursday morning. Michigan is close behind with 44 fungal meningitis cases, four deaths, and four non-meningitis infections, per the Morning Sun.
Wednesday, Rep. Dingell asked whether “slovenly manufacturing practices” led to the contamination of NECC’s epidural steroid and other products, according to the New York Times.
Michigan Rep. Fred Upton likewise wrote to the FDA seeking inspection reports dating back to January 1, 2004, for both NECC and Ameridose. The latter “provides the highest quality in outsourced sterile admixed preparations and prefilled oral syringes to hospital pharmacies throughout the United States,” its website states. It also shares owners with NECC.
Ameridose’s website boasts that it’s the best choice for patient safety and claims to employ “rigorous process controls” and an environment that “ensure[s] absolute accuracy and sterility.” But technicians and pharmacists told the Times that they had concerns about drug safety and co-worker qualifications. As one employee said, “The emphasis was always on speed, not on doing the job right.” Read rest of post by clicking here
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