Federal Agents Raid Pharmacy Tied To Meningitis Outbreak
Farmington, Massachusetts – The FDA’s Federal agents raid the pharmacy link to the Fungal Meningitis outbreak. A steroid manufactured by the New England Compounding Center, has been linked to the meningitis outbreak that has killed 21 people and sickened over 250, according to published reports.
The U.S. Food and Drug Administration’s agents of Criminal Investigations were armed with a federal search warrant, and seen entering the New England Compounding Center in Framingham, Massacusetts.
Since, investigators have traced the source of the outbreak to the Farmington facility, there has been an increasing evidence that the New England Compounding Center (NECC), has actuallyin engaged in manufacturing drugs, even though the facility is not licensed as a drug manufaturer.
Federal Officials, found that NECC has tried to obtain bulk orders from physicians, and failed to require proof of each patient’s prescription.
The State pharmacy regulators said, The NECC violated their license in Massachusetts by not requiring patient prescriptions before shipping products.
Paul Cirel, of the firm Collora LLP in Boston, said in a statement,”It is difficult to understand the purpose of this search, since we have been clear that (NECC) would provide, and has provided, anything requested. We’ve been clear that warrants weren’t needed.”
The list of recalled NECC drug products appears to include nearly 1,000 specific formulations that contain controlled substances that fall under the attention of the Drug Enforcement Agency, including substances such as cocaine, morphine, hydromorphone, meperidine, sufentanil, fentanyl, and ketamine.
Federal Officials, confirmed the presence of a fungus in unopened vials of steroids that matches the type of infection found in most of the sick patients.
The FDA said, it had also received reports of a patient with possible meningitis, who received an injection of a different steroid other than the one that caused the deaths, and within days the investigation was extended to see if the cause of the outbreak was linked to other drugs made by the NECC.
The New England Compounding Center recalled three lots of the tainted injections used for back, neck, and joint pain.
Almost 14,000 people across the nation are at risk of infection because they received injections from suspect steroid medications shipped to 76 facilities in 23 states.
All, but eight of the 23 states that received the medications from the pharmacy have reported at least one case of fungal meningitis.