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четверг, 21 февраля 2013 г.

NECC had to be sentenced to severe penalties earlier


In 2003 the FDA had in mind to shut down the New England Compounding Center (NECC) which lately caused the meningitis outbreak in several states of America. The Massachusetts pharmacy manufactured contaminated Methylprednisolone Acetate injections. Over 400 persons that administered the contaminated steroid injections were sickened with fungal meningitis. This disease turned out to be tragic for 39 individuals.
According to a late report published by the House of Energy and Commerce Committee, the meningitis outbreak could have been prevented. The report disclosed numerous cases related to the Massachusetts pharmacy that should have been closed by the FDA earlier.
The FDA stated in 2003 that the NECC should not have manufactured drugs till improving of the situation. But ultimately the FDA didn’t prohibit manufacture of products at the NECC. Since the NECC was considered to be a pharmacy, it should have been monitored by Massachusetts officials. So, the FDA let Massachusetts colleagues to resolve the problem. As for Massachusetts officials, they didn’t prohibit manufacture of drugs at once. The NECC continued to produce medicines. Just Barry Cadden, the owner of the pharmacy, received reprimand.
Furthermore, the NECC was guilty of some illicit operations. The company acted inappropriately under its license. Being a pharmacy, the NECC acted as a manufacturer and sent thousands dosages of medicines to hospitals and individual patients.
In 2002 several individuals suffered from unusual side reactions after they had applied bethamethasone injections manufactured by the Massachusetts pharmacy.
Later several individuals who administered methylprednisolone acetate injections produced by the Massachusetts pharmacy were contaminated with bacterial meningitis. Since these individuals got complete recovery because of antibiotics, the case was forgotten. The NECC was not punished for the contaminated products.
These and even certain other cases show that the NECC should have sanctioned earlier. The NECC should have been shut down for its illicit and improper actions. But the Massachusetts pharmacy was never sentenced to any serious penalties. As a result, the pharmacy continued to produce preparations which were dangerous for consumers’ health. Finally, the meningitis outbreak caused by tainted injections of the Massachusetts pharmacy spread to several states and sickened a lot of persons. If the pharmacy had been closed earlier, the contamination with deadly fungal meningitis would not have occurred.

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