By Cameron Stephenson
October 16th 2012 1:30pm
The New England Compounding Center (NECC), located in Framingham, Massachusetts, has now killed 15 people and left over 200 sick. These numbers, growing literally by the hour, leave no question that this company directly caused one of the deadliest outbreaks of fungal meningitis to date. But, how deep does the story go? We all know this company is responsible, but where was the regulatory oversight and why was it not enforced?
NECC is a specialized compounding pharmacy that, unlike Big Pharma giants Pfizer and Merck, is not regulated at the federal level by the Food and Drug Administration (FDA). Rather, due to its compounding nature, NECC operates under questionable loophole status, thus subjecting itself to regulation at the state level only. Pursuant to its licensing through the Massachusetts’ Board of Pharmacy, NECC is only permitted to manufacture and deliver compounded products in response to “individual patient specific prescriptions.” However, according to the Massachusetts’ Department of Health, NECC was acting well beyond its state license by mass producing and distributing compounded medications in bulk, not in response to individual patient prescription orders.
“The New England Compounding Center was masquerading as a compounding pharmacy so it could escape federal regulation when it was actually operating as a drug manufacturer,” said Rep. Edward Markey, D-Mass., who sits on the Energy and Commerce Committee, which has jurisdiction over the FDA.
It should be of no surprise to anyone, let alone the Massachusetts’ Board of Pharmacy, that compounding pharmacies, such as NECC, have operated beyond their license and in violation of state law for years. In fact, two of the original founders of New England Compounding Pharmacy, Inc., which currently operates as NECC, also formed a company in 2006 called Ameridose that, just this past summer, had numerous sizeable hospital contracts cancelled over significant allegations regarding poor quality control practices which “rose to a level of concern for patient safety.” Moreover, NECC previously settled claims for similar conduct as recently as 2007, where an 83 year old man contracted bacterial meningitis and died after receiving an NECC tainted shot at Rochester General Hospital in New York. The list of malfeasance goes on and on.
When this conduct is so prevalent and well known in the industry, maybe we are asking the wrong question. Perhaps the question should not be, where is the oversight, but rather, is there any incentive to NOT enforce the oversight that exists?
These compounding pharmacies generate tremendous revenue for themselves and the states in which they are located. Frankly, I don’t think anyone is worrying about enforcing anything, as long as the money keeps on rolling in.
“It’s abysmal that the local authorities are calling for greater oversight. If someone just enforced Massachusetts law, these cases could have been avoided. They failed in their responsibility for enforcing what they already had.” Eric Kastango, committee member for the US Pharmacopeia (USP), the industry body behind sterile drug compounding regulations.
“Profits over people” is not a novel theory for Big Pharma, it is a well-established mission statement. It does not matter what regulations you bend, break, or follow, as long as your profits are greater than your expected and anticipated liability. It literally is a calculation: If profits minus the cost spent compensating victims is greater than zero, then there is financial justification in continuing production, that simple. The problem: where is morality in that equation? I did not see it either. These practices will not change until the Court of Public Opinion forces reform. Who knows when that will happen?
More information on the Meningitis outbreak.
Cameron Stephenson is a lawyer with the Levin, Papantonio law firm in Pensacola, Florida, and handles medical malpractice and other wrongful death cases. He has devoted his legal practice to fighting for the rights of Florida’s injured patients.