четверг, 21 февраля 2013 г.

Massachusetts officials had to close NECC in 2003


In 2003 the FDA had in mind to close the New England Compounding Center (NECC) that last year caused the meningitis outbreak in certain states of America. The Massachusetts pharmacy produced tainted Methylprednisolone Acetate injections. More than 400 individuals who administered the contaminated steroid injections were sickened with fungal meningitis. This disease turned out to be tragic for 39 persons.
According to a late report written by the House of Energy and Commerce Committee, the meningitis outbreak could have been prevented. The report revealed numerous cases linked with the Massachusetts pharmacy that should have been shut down by the FDA earlier.
The FDA stated in 2003 that the NECC should not have produced preparations till improving of the situation. But finally the FDA didn’t prohibit manufacture of medicines at the NECC. Since the NECC was claimed to be a pharmacy, it should have been ruled by Massachusetts officials. So, the FDA let Massachusetts colleagues to improve the situation. As for Massachusetts officials, they didn’t prohibit manufacture of drugs at once. The NECC continued to manufacture medications. Only Barry Cadden, the owner of the company, received reprimand.
Furthermore, the Massachusetts pharmacy was guilty of several illegal operations. The company acted improperly under its license. Being a pharmacy, the NECC acted as a manufacturer and shipped thousands doses of medications to hospitals and individual patients.
In 2002 certain persons experienced unusual adverse reactions after they had administered bethamethasone injections produced by the NECC.
Later some individuals that received methylprednisolone acetate injections manufactured by the NECC were contaminated with bacterial meningitis. Since these individuals got full recovery because of antibiotics, the case was forgotten. The Massachusetts pharmacy was not punished for the tainted medicines.
These and even some other cases manifest that the Massachusetts pharmacy should have punished earlier. The company should have been closed for its illicit and inappropriate actions. But the Compounding Center was never sentenced to any severe penalties. As a result, the company continued to produce preparations that were dangerous for consumers’ health. Finally, the meningitis outbreak caused by contaminated injections of the Massachusetts pharmacy spread to certain states and sickened many persons. If the pharmacy had been closed earlier, the contamination with deadly fungal meningitis would not have occurred.

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