AG: Suspend license of company linked to meningitis outbreak

The office of Attorney General Bill Schuette has filed an administrative complaint requesting the immediate suspension of the pharmacy license for New England Compounding Center (NECC), a company linked to the recent meningitis outbreak in Michigan. Schuette's office has also launched an investigation in coordination with the Department of Community Health and the Department of Licensing and Regulatory Affairs to determine whether further legal action is warranted. ''Michigan citizens demand that drug manufacturers follow the laws designed to keep consumers safe,'' said Schuette. ''In this case, mistakes resulted in tragedy for Michigan families. We will take every step necessary to restore public safety and welfare, and we have launched an official investigation to determine whether additional civil or criminal action is warranted.'' Pursuant to state law, Schuette's office filed a complaint and order of summary suspension with the Department of Licensing and Regulatory Affairs alleging that NECC was acting as a drug manufacturer by distributing large amounts of medication to various hospitals and clinics in Michigan. The company is currently only licensed to fill individual prescriptions for Michigan patients. Once the order of summary suspension has been signed by the Bureau of Health Professions Director, NECC's license will be immediately suspended and they will be forced to cease operations in Michigan. A formal hearing is required in the Michigan Administrative Hearings System (MAHS) to dissolve the suspension prior to full adjudication, where a judge will determine the merits. Schuette noted that in addition to the immediate licensing action, he is reviewing whether additional legal action is warranted in connection to the outbreak of rare fungal meningitis linked to contaminated steroids manufactured by NECC. The medication was shipped by NECC in bulk without obtaining the proper Manufacturer's License. Immediately following the outbreak, the Michigan Department of Community Health (MDCH) worked with four Michigan facilities that received the product to contact approximately 1,900 individuals who had received an injection of this product during the time frame it was available. Patient notification is complete for all individuals who received an epidural injection, and according to the MDCH, only individuals who received an epidural injection are at risk of contracting fungal meningitis. The disease does not spread person to person. On October 6, 2012, NECC issued a voluntary recall of all its products currently in circulation that were produced and distributed from its facility in Framingham, Massachusetts. As of Oct. 16, 46 Michigan citizens have been associated with the meningitis investigation linked to epidural steroid injections and three people have died as a result. Nationally, there have been 15 deaths in six states. Published: Thu, Oct 18, 2012

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