Company responsible for fungal meningitis cases skirted state and federal laws
On October 14, the Centers for Disease Control and Prevention (CDC) announced that the number of individuals diagnosed with virulent fungal meningitis infections has risen to 205 in 14 states. The current death toll stands at 15; however, some of the infected individuals are seriously ill and/or suffered strokes. Seven new cases have been confirmed in New Hampshire, Florida, Indiana, and Tennessee.
All but two of the infected individuals received a tainted methylprednisolone acetate epidural injection; the other two cases received the steroid injection into a joint. The CDC notes that Tennessee continues to be the hardest hit state; 53 cases of meningitis and six deaths have occurred in the state. Michigan contains the second highest number of cases (41cases and three deaths, followed by Virginia (34 cases and one death). The New England Compounding Center (NECC) in Framingham, Massachusetts produced the contaminated vials of the steroid and shipped them to 23 states and 76 medical facilities; the outbreak has become a major issue. NECC has recalled the product and suspended operations.
The CDC is continuing to investigate the situation and notes that 14,000 individuals received the medication as a steroid injection either into the spinal area or into a joint space such as a knee, shoulder or ankle. All 14,000 are at risk of developing fungal meningitis because the incubation time varies. The situation has raised questions about how the pharmaceuticals industry operates. NECC engaged in a little-known practice called drug compounding that is not regulated by the Food and Drug Administration (FDA), which generally oversees drug makers.
Massachusetts state and federal investigators believe that the steroid was contaminated at NECC’s facility in a brick building in Framingham; they found unused vials of the medication with Exserohilum fungus growing inside. In addition to NECC, two affiliated companies have ceased operation. To date, at least one lawsuit seeking class-action status has been filed, in federal court in St. Paul, Minnesota.
Interviews with former employees, customers, and industry experts, as well as regulatory documents, describe a family business that, while having only about 50 employees, became a sophisticated interstate operation behaving in some ways more like a traditional drug maker than the pharmacy it was licensed to be. NECC supplied dozens of medicines in bulk to clinics around the nation. The company promoted its products in marketing materials and at medical conferences alongside big drug companies, and developed a reputation as a fast, productive operation that could supply products when competitors were hampered by shortages. However, NECC operated without the regulatory oversight traditional pharmaceutical manufacturers must deal with, including FDA inspections. Oversight of pharmacies is under the jurisdiction of state boards of pharmacy. The Massachusetts health department conducted on-site visits.
NECC produces alternative versions of medicines, such as liquid forms of pills, and mixes therapies from raw ingredients. The company was supposed to make medicines for individual patients; under Massachusetts pharmacy rules, NECC was mandated to only produce a medication after receiving a patient-specific prescription. The state policy prohibits the bulk sale of medicines by compounding pharmacies outside of the state; however, several customers have reported that they never supplied patient prescriptions to NECC, and ordered the medicines they needed in bulk.
NECC has come under FDA scrutiny in the past. In 2006, the agency issued a warning to NECC that it was operating “like a manufacturer,” engaging in activities, such as making FDA-approved products and marketing to doctors with free samples, which might bring it under the FDA’s oversight. In a letter to NECC, the FDA noted that using “courtesy prescriptions” to generate sales is “not consistent with the traditional practice of pharmacy compounding.” The letter noted that the FDA had seen advertising that NECC was offering for Avastin, a prescription cancer drug, repackaged into syringes for use in the eye. Avastin does not have FDA approval for this use; thus, the agency expressed concern regarding the potential for microbial contamination when sterile containers are opened and manipulated. The letter added that the FDA would not exercise its enforcement discretion; however, it asked NECC to take “prompt action to correct these deviations.” The FDA noted that it “took all possible step to address any wrongdoing.” It added that the violations did not include contamination.
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