In 2003 the FDA had in mind to shut down the New England Compounding Center (NECC) that recently caused the meningitis outbreak in several states of America. The Massachusetts pharmacy manufactured tainted Methylprednisolone Acetate injections. More than 400 persons who applied the contaminated steroid injections were sickened with fungal meningitis. This disease 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 disclosed numerous cases linked with the NECC which should have been shut down by the FDA earlier.
The FDA claimed in 2003 that the NECC should not have produced drugs till improving of the situation. But finally the FDA didn’t ban manufacture of medications at the NECC. Since the NECC was considered 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 ban manufacture of products immediately. The company continued to produce medicines. Just Barry Cadden, the owner of the company, got reprimand.
Moreover, the NECC was guilty of several illegal activities. The company acted improperly under its license. While the NECC was a pharmacy, it acted as a manufacturer and shipped thousands dosages of medications to hospitals and individual patients.
In 2002 several persons experienced unusual side effects after they had applied bethamethasone injections produced by the Massachusetts pharmacy.
Later certain individuals that administered methylprednisolone acetate injections produced by the NECC were contaminated with bacterial meningitis. Since these persons got full recovery because of antibiotics, the case was forgotten. The Massachusetts company was not punished for the contaminated drugs.
These and even several other cases show that the NECC should have punished earlier. The company should have been shut down for its illicit and inappropriate actions. But the Massachusetts pharmacy 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 NECC spread to some states and sickened a lot of individuals. If the company had been shut down earlier, the contamination with deadly fungal meningitis would not have taken place.
Комментариев нет:
Отправить комментарий