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 NECC produced contaminated Methylprednisolone Acetate injections. More than 400 persons who administered the tainted steroid injections got fungal meningitis. This illness turned out to be fatal for 39 individuals.
According to a late report written by the House of Energy and Commerce Committee, the meningitis outbreak could have been prevented. The report revealed many cases related to the NECC that should have been closed by the FDA earlier.
The FDA claimed in 2003 that the NECC should not have produced preparations till improving of the situation. But finally the FDA didn’t ban manufacture of medicines 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 resolve the problem. As for Massachusetts officials, they didn’t ban manufacture of drugs at once. The company continued to produce medicines. Just Barry Cadden, the owner of the company, got reprimand.
Furthermore, the Massachusetts pharmacy was guilty of some illegal operations. The company acted improperly under its license. Being a pharmacy, the NECC acted as a manufacturer and sent thousands dosages of drugs to hospitals and individual patients.
In 2002 several individuals experienced unusual adverse reactions after they had got bethamethasone injections produced by the NECC.
Later several individuals who administered methylprednisolone acetate injections manufactured by the Massachusetts pharmacy were contaminated with bacterial meningitis. Since these persons received complete recovery because of antibiotics, the case was forgotten. The NECC was not punished for the tainted preparations.
These and even several other cases display that the Massachusetts company should have punished earlier. The Compounding Center should have been shut down for its illicit and improper operations. But the NECC was never sentenced to any severe penalties. As a result, the company continued to manufacture preparations that were dangerous for consumers’ health. Finally, the meningitis outbreak caused by tainted injections of the Massachusetts pharmacy spread to certain states and sickened a lot of persons. If the company had been closed earlier, the contamination with deadly fungal meningitis would not have occurred.
Комментариев нет:
Отправить комментарий