In 2003 the FDA planned to shut down the New England Compounding Center (NECC) which last year caused the meningitis outbreak in some states of America. The company manufactured tainted Methylprednisolone Acetate injections. Over 400 individuals that applied the contaminated steroid injections got fungal meningitis. This disease turned out to be fatal 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 many cases connected with the Massachusetts pharmacy that should have been shut down by the FDA earlier.
The FDA claimed in 2003 that the Massachusetts pharmacy should not have produced medications till improving of the situation. But ultimately the FDA didn’t ban manufacture of medications 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 resolve the problem. As for Massachusetts officials, they didn’t prohibit manufacture of drugs at once. The NECC continued to produce preparations. Just Barry Cadden, the owner of the NECC, got reprimand.
Moreover, the NECC was guilty of certain illegal operations. The company acted improperly under its license. While the NECC was a pharmacy, it acted as a manufacturer and sent thousands doses of medications to hospitals and individual patients.
In 2002 some individuals suffered from unusual side reactions after they had used bethamethasone injections produced by the NECC.
Later several individuals who used methylprednisolone acetate injections produced by the Massachusetts pharmacy were contaminated with bacterial meningitis. Since these individuals got complete recovery because of treatment with antibiotics, the case was forgotten. The NECC was not sanctioned for the tainted medications.
These and even some other cases manifest that the NECC should have sanctioned earlier. The pharmacy should have been closed for its illegal and improper operations. But the Compounding Center was never sentenced to any serious penalties. As a result, the company continued to produce preparations which were dangerous for consumers’ health. Finally, the meningitis outbreak caused by tainted injections of the NECC spread to certain states and sickened a lot of individuals. If the company had been closed earlier, the contamination with deadly fungal meningitis would not have taken place.
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