A Massachusetts bankruptcy judge gave verbal approval for a $200 million settlement plan for victims of a national meningitis outbreak linked to the New England Compounding Center, the Boston Business Journal reports. Continue reading
WBUR’s Martha Bebinger reports:
The sister company of the Framingham pharmacy linked to the nationwide meningitis outbreak is temporarily laying off 790 employees.
Ameridose and its marketing company, Medical Sales Management share owners with New England Compounding Center, the pharmacy tied to steroids tainted with a deadly fungus. Ameridose has been under investigation and closed for more than a month even though inspectors have not found problems with any Ameridose products. Sources say the closure is costing Ameridose more than a million dollars a week. In a letter to employees, Human Resources director Geri Weinstein says Ameridose hopes the layoffs are temporary and that employees will be brought back to work. But Weinstein says that while the company expects to reopen, it will likely be at a reduced level.
Even with the layoffs, some employees will remain, according to a company spokesperson, who said: “Enough staff has been kept on to both manage the recall that is underway and to implement the recommendations that are expected from the FDA.”
Here’s a copy of the letter to employees:
Responding to reports of the layoffs, the Massachusetts Hospital Association put out this statement:
“While not commenting directly on Ameridose’s actions regarding its employees, the company’s cessation of production of important medications aggravates an increasingly serious problem of drug shortages for hospitals. MHA and its hospital members will continue to work with DPH in an effort to address this issue and seek alternative sources of needed medications.”
WBUR’s Martha Bebinger reports:
Federal officials say as many as 14,000 people may have been exposed to tainted medication from the New England Compounding Center.
State and federal regulators say they are still investigating the exact cause of the outbreak. But the FDA’s Deborah Autor says regulators would like more clarity about state and federal authority over such pharmacies.
State regulators say it appears that the New England Compounding Center violated state law by supplying large amounts of medicines without an individual prescription.
Sources close to the investigation says NECC followed state laws.
The Massachusetts Department of Public Health says New England Compounding Center was licensed to mix specialized medications based on individual prescriptions. So selling vials of steriods in bulk to hospitals across the country, where 169 patients are now ill from tainted injections, was not allowed, says Madeleine Biondolillo, with the DPH. Continue reading
An official from the CDC suggested today that any “concerned” patient who has had steroid injections for back pain since July might want to contact their doctor to make sure the drugs used were not part of a recalled batch.
Three batches of the steroid, Methylprednisolone Acetate (now recalled) have been linked to an outbreak of rare fungal meningitis. As of Thursday, officials say that 35 cases in 6 states, including five deaths, have been reported.
Moreover they said in a conference call with reporters today, that 23 states, including New York, New Jersey, Rhode Island, Connecticut and New Hampshire, have received the steroid that was recalled.
As previously reported, a compounding pharmacy in Framingham, the New England Compounding Center, is at the center of the investigation. AP reported earlier today that the NECC has voluntarily suspended operations:
In a statement Wednesday, the New England Compounding Center said it was working closely with the Massachusetts Department of Public Health and other regulators to identify the source of infection.
The company said that immediately after it was notified about the infections it initiated a voluntary recall Sept. 26.
This just in from the state Department of Public Health:
BOSTON – The Massachusetts Department of Public Health (DPH) today released a statement regarding the investigation of the national meningitis outbreak:
“The Massachusetts Department of Public Health is collaborating with the CDC, FDA, and other state public health officials to identify the cause of an outbreak of more than 25 suspected cases of aspergillus (fungal) meningitis under investigation in Florida, Maryland, North Carolina, Tennessee and Virginia. The cause for this cluster of cases is not yet known. There are four products common to all of these cases. One medication, Methylprednisolone Acetate, a steroid, was prepared at the New England Compounding Center, Inc (NECC), a pharmacy in Framingham, Massachusetts. It has been recalled and quarantined as a precaution. NECC is voluntarily recalling all similar medications. In addition, at the request of DPH, NECC has agreed to voluntarily surrender their license to operate until this investigation is complete. The form of fungal meningitis in these patients is not transmitted from person to person. There are no known cases in the Commonwealth.”
Here’s a statement emailed from the FDA:
FDA is working with CDC, several state health departments and the Massachusetts Board of Pharmacy on this issue and is still investigating the scope and cause of the outbreak of fungal meningitis.
What I can tell you is that on September 26, New England Compounding Center (NECC) conducted a voluntary recall of 3 lots of Methylprednisolone (PF) 80mg/ml Injection produced at NECC. The lot numbers of this product are:
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, Beyond Use Date (BUD) 11/17/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012
Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013