четверг, 21 февраля 2013 г.

FDA had to punish NECC earlier


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

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