Governor Rick Snyder and Attorney General Bill Schuette today announced that an administrative complaint has been filed 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.
“Nothing is more important than the health and safety of Michigan families,” Snyder said. “Consumers deserve to have confidence in any product they receive, especially medical products. Our teams are moving swiftly in a coordinated approach to prevent this tragedy from posing further risks to our citizens.”
“Michigan citizens demand that drug manufacturers follow the laws designed to keep consumers safe,” said Schuette. “In this case, mistakes resulted in unspeakable 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 today 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. More information about the recall, including a list of affected medications can be found here: http://www.neccrx.com.
MDCH is currently reporting that 41 Michigan citizens have been associated with the Meningitis investigation linked to epidural steroid injections and three people have died as a result. As of Oct. 12, 184 people have been infected and 14 have died, according to the Centers for Disease Control and Prevention (CDC). The CDC reports can be viewed online:http://www.cdc.gov/hai/outbreaks/meningitis-map.html.