A salesman from the firm that produced the tainted drugs linked with last year’s deadly fungal meningitis outbreak revealed that the lab made up prescriptions for fake customers in order to evade federal restrictions on drug manufacture.
To get around regulations on large-scale drug production by compounding pharmacies, clinics requested prescriptions with invented names such as “Bill Smith,” “Jane Doe,”’ and even “Homer Simpson,” the salesman told the CBS news magazine 60 Minutes, according to the Daily Mail (U.K.).
The New England Compounding Center (NECC), which produced the drugs responsible for the fungal disease that has killed 48 people and sickened more than 700, was only supposed to manufacture specific drugs for individual patients, but, the salesman claimed, the firm had as many as 3,000 clients.
As we’ve previously explained, compounding is a vital service for patients who cannot be treated with U.S. Food and Drug Administration (FDA)-approved medications and requires individually formulated medicines; for example, people allergic to certain dyes or inactive ingredients, or those who need a medication in a form not commonly available. Compounding pharmacies are supposed to produce these medicines on an individual basis, but Joe Connolly, a former NECC technician, said that in the year before the start of the meningitis outbreak, the company increased its output almost a thousand times, the Daily Mail reported. NECC was operating as a manufacturer without the federal oversight drug manufacturers are subjected to.
In September, patients who had been treated with injections of methylprednisolone acetate produced by NECC began to fall ill with fungal meningitis. According to the U.S. Centers for Disease Control and Prevention (CDC), new illnesses are still being reported nearly six months after the start of the outbreak. NECC has now gone out of business and its owner, Barry Cadden, has refused to comment on the allegations made by 60 Minutes. He invoked his Fifth Amendment right to avoid testifying to Congress, the Daily Mail said.