The Massachusetts company that supplied the drugs that have caused 247 cases of fungal meningitis - including one in this area - should have been shut down by the Food and Drug Administration years ago, an expert with Public Citizen's Health Research Group said Thursday.
New England Compounding Center is a "compounding pharmacy" that operates as a drug manufacturer under an oversight framework intended for custom compounding of drugs for individual patient prescriptions, Michael Carome said.
It was the target of a warning letter from the FDA in 2006 for overstepping its regulatory bounds, but the FDA failed to follow up with an injunction or seizure that would have put a stop to the company's operations, which have led to 19 deaths recently, Carome said.
The FDA's regulatory authority over compounding pharmacies is more limited by statute than its authority over typical drug manufacturers, agency spokeswoman Sarah Clark-Lynn said.
"Compounding pharmacies and pharmacists are responsible for the quality and safety of the drugs they produce," she stated.
Compounding pharmacies actually have an older history than true drug manufacturing companies that operate under the FDA regulations for manufacturers, based on the 1938 Food, Drug and Cosmetic Act, which gave the FDA approval authority over the manufacture of drugs and a 1962 amendment, which required new drugs to be effective, Carome said.
But compounding pharmacies - which include many regular drugstores, including mom and pop operations - declined in importance.
Beginning in the 1950s, they filled no more than a narrow niche, under regulatory oversight by state boards of pharmacy, he said.
That proper niche is to prepare prescriptions for individual patients who have an allergy to commercial medications, who need a drug that is not commercially available or who need it in a specialized form or strength, said David Ball, spokesman for the International Academy of Compounding Pharmacists.
The FDA always claimed authority over such processes, saying they were subject to its approval for good practices, but used "enforcement discretion," and didn't press, because it would be impractical to force those pharmacies to go through complex approval processes for such limited activities.
But starting in the 1990s, some compounding pharmacies began expanding their operations, "behaving like drug companies," Carome said.
They began making drugs on a large scale, making large quantities of standardized doses and selling within their states and across state lines.
NECC was licensed in all 50 states, Carome said.
Its product list - published for a voluntary recall by FDA - is about 70 electronic pages.
For "whatever reason," NECC was permitted to continue operating, despite the 2006 letter, the injunction, seizure and criminal and civil penalties that might have been available, Carome said.
"What you see going on now is what can happen," he said.
He doesn't know specifically what happened, he said.
"But I think I know generically," he said.
If a company doesn't follow good manufacturing practices laid out in regulations under FDA, "it sets you up for all sorts of problems," he said.
The fungus that is causing the problem could have been introduced in any one of a variety of steps, Carome said.
It could have resulted in a failure to wear sterile gloves, it could have been spores floating into what should have been sterile vials, it could have been the failure of final sterilization, it could have been because the company didn't test the product for contamination, he said.
Not only NECC, FDA and state regulators, but Congress and the providers who bought products from such companies are to blame, Carome said.
One such provider was Allegheny Pain Management of Altoona, one of whose patients has contracted fungal meningitis from medicine supplied by NECC, according to the state Department of Health.
Maybe those providers don't fully understand the inadequacies in quality, Carome said.
Maybe they're driven by the wish to lower their costs, he said.
That widespread blame is likely to "ensnare" many through lawsuits that could go on for years, he said.
Asked whether Allegheny Pain Management could be at risk for disciplinary measures or penalties or whether it was under investigation, Health spokeswoman Aimee Tysarczyk said, "Our current efforts are focused on public health and patient safety."
The department has been monitoring patients who received medicines from NECC, Tysarczyk said.
The Mirror left a message for Allegheny's medical director after the facility closed Thursday, asking for comment on Carome's criticism, but didn't hear back.
Earlier in the day, a spokesman for the clinic spoke only cryptically about a TV report that there might be a second patient who contracted meningitis through NECC medications administered by Allegheny.
That spokeswoman, Practice Administrator Lisa McElheny, also was not forthcoming about why the clinic first gave reassurances that there was no problem when the news about NECC broke early this month.
A state Health Department spokeswoman speculated that it could have resulted from an early, widespread and mistaken belief that the only problematic drugs were in a manufacturer's lot that didn't come to the Pennsylvania clinics.
Dr. Robert Sullivan of Altoona said the clinic might not have known which samples came from which of three manufacturer's lots, and that such knowledge wasn't necessarily required.
Sullivan doesn't think the second patient has fungal meningitis, because his white cell count isn't high. But the patient is being monitored, he said.
Fungal meningitis can be difficult to diagnose, because the symptoms are not unique to meningitis, because indicator cells in the spinal fluid are not numerous and because the infection itself is slow-growing, Sullivan said.
Mirror Staff Writer William Kibler is at 949-7038.
