Meningitis Outbreak Raises Questions of Compounding Agency Regulation
Ennis & Ennis, P.A. Outlines the Need for Regulation over Compounding Facilities
- Ennis & Ennis
10/12/2012 - As the number of confirmed meningitis cases continue to increase, the regulation of compounding agencies comes into question. Contaminated products compounded at The New England Compounding Center (NECC) in Massachusetts are responsible for the recent meningitis outbreak, according to FDA.
Pharmacy compounding involves pharmacists combining, mixing, or altering ingredients to create unique medications that meet specific needs of individual patients, according to the FDA. Interestingly, compounded drugs are not FDA-approved. This means that the FDA has not verified their safety and effectiveness. In the wake of the outbreak, lawmakers are now questioning whether the FDA should have more oversight on these facilities.
While NECC has shut down, Massachusetts health officials have extended their investigation to Ameridose, which shares common ownership. NECC and Ameridose are owned by Gregory Conigliaro, an engineer and entrepreneur, and his brother-in-law Barry Cadden, a pharmacist.
Despite the FDA not regulating compounding agencies, Peter Barton Hutt, former FDA chief counsel, feels the FDA could have stepped in long ago to shut down NECC, reports The Tennessean Gannett. According to Hutt, a 1938 law prohibits drug stockpiling and the compounding of a competing drug that is already FDA approved. In fact the FDA sent a letter to NECC in 2006 warning it should not be manufacturing commercially available drugs. Hutt feels that the FDA had oversight in this regard and could have regulated NECC’s practices.
However this is a vague area of law that is subject to debate due to unclear legislation. A deeper look reveals that during the 70’s and 80’s, the FDA cracked down on some compounding pharmacies that began to mass produce drugs and advertise their products. In 1997 some compounding laws were established, but then in 2002 the Supreme Court struck down a portion of the law that prevented compounding agencies from advertising their products citing free speech concerns. A 2008 case ruled that the Supreme Court’s ruling only applied to the advertising portion of the law, but still allowed for mass production. This, in effect, created confusion and vagueness over the state and federal regulation of these facilities.
“If nothing else comes of this tragic meningitis outbreak, let it at least establish the urgent need of strict regulation over compounding facilities,” states attorney David Ennis of Ennis & Ennis, P.A.
Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who received the NECC products and contracted fungal meningitis by calling toll free 1-800-856-6405 or by filling out the free online case evaluation form on this page.
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