Drug company behind fungal meningitis outbreak sold drugs without prescriptions
Massachusetts firm distributed thousands of contaminated steroid for back pains that led to outbreak
The Massachusetts firm that supplied tainted steroids to consumers which in turn led to a fungal meningitis outbreak broke several laws, chief among them selling drugs without prescriptions. The contaminated steroids have since been recalled, but more than 200 people have fallen ill and 15 have died on account of the drug.
The New England Compounding Center solicited bulk orders from physicians and failed to require proof of individual patient prescriptions as required under state regulations.
One customer has confirmed via email to Reuters that the company supplied the clinic with drugs without patient names or prescriptions. Thousands of vials of the contaminated steroid have since been distributed, putting 14,000 people at risk of contracting meningitis.
The center solicited bulk orders from physicians and failed to require proof of individual patient prescriptions as required under state regulations. Further emails support assertions made this week by state pharmacy regulators that the compounding firm had violated its license in Massachusetts.
Other emails indicate that NECC referred business to a sister company, Ameridose LLC, despite a statement by Ameridose earlier this week that the two operated separately. Both firms mix, dilute or repackage drugs that may not be easily available through a pharmaceutical manufacturer.
Both are owned by Gregory Conigliaro, an engineer, and his brother-in-law, Barry Cadden, a pharmacist who was in charge of pharmacy operations at NECC until it surrendered its license in the wake of the meningitis outbreak.
"NECC's intent has always been to operate in compliance with our licenses in the states where we do business, and we have made our best efforts to be in compliance with all governing laws and regulations during 15 years of providing hundreds of thousands of patients with vital medications," NECC said in a statement.
"We are cooperating with agencies that have a policy of not commenting on pending investigations, and as part of that cooperation we are honoring that policy and not commenting on specific facts."
Ameridose has closed for 12 days pending state and federal inspections. Regulators say they have not found Ameridose's products to be compromised and they have not requested a recall.
"Although there is common ownership, the two companies operate under separate registrations and different licensure," Ameridose said.
Another company, Alaunus Pharmaceutical LLC, which distributes drugs for Ameridose and also is owned by Conigliaro and Cadden, suspended its operations this week.
The fourteen U.S. states believed to have received the contaminated steroids include Florida, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, North Carolina, Ohio, Tennessee, Texas and Virginia.
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