The owners of New England Compounding Center, the Framingham company at the heart of a nationwide outbreak of fungal meningitis, also own a related pharmacy in Westborough, one of whose executives is a board member and former president of the state agency that regulates pharmacies.
Sophia Pasedis was appointed to the 11-member Massachusetts Board of Registration in Pharmacy in June 2004 and was reappointed in 2008. She is vice president of regulatory affairs and compliance at Ameridose, according to the company’s website.
Comments
Per the Wall Street Journal, "The compounding pharmacy industry has created safety standards meant to reduce the risk of tainted products. In 2004, United States Pharmacopeia, an industry-backed nonprofit, established safe-practice guidelines for compounding pharmacies. But the industry is required only in 17 states to follow the guidelines, according to a survey conducted this year by Pharmacy Purchasing & Products, a trade publication. Researchers found that compounding pharmacies in states that required the guidelines reported higher levels of compliance." >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> So, Massachusetts should explain why it was not one of those 17 states requiring compliance with the voluntary standard, given the know laxity of federal standards. Also, I ask the Globe to reveal which states DO require compliance so we can see which states really have their management act together and really care about the people's safety. (Interesting that NECC, despite being in Framingham, did not ship to any MA locations.)
On a related note, I would like to know specifics about NECC's QA standards and why they failed to detect the contamination.
This comment has been removed.
I'm sure the lack of regulation created some good jobs at NECC -- was it worth it?
So where's the Globe's interviews with Martha Coakley and Deval Patrick concerning the meningitis otbreak and the State drug lab scandal? --or is the Globe afraid to disturb Deval who is busy performing his offical State duties of campaigning for Barack Obama?
So, Markey claims he is going to "strengthen the oversight of pharmacy regulation."
WHO is in charge of pharaceutical oversight & regulation?
Is this another neopitism or a political appointment?
Typical state employee reaction - lay low, under the radar. The lack of administration and oversight of policies & procedures is astounding: The same issue as what happened at the State Lab for years & years. State administration without the skills to respond to the numerous issues reported by their immediate staff.
So let me see if I have this right. According to Gov Patrick (per what I just heard on NPR) NECC was violating the terms of its state license by shipping drugs to other than individual patients. They have surrendered their license. But does the Governor think the regulatory body (under the DPH) did not know what NECC was doing, or did know? The problem batches were given to 13,000 people and shipped to 23 states? Either state regulators knew and did nothing (or nothing that was effective), or they didn't know (that, speaking personally, is hard for me to believe).