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State records show that inspectors knew about problems with an injectable steroid produced at a Framingham specialty pharmacy going back to 2002 — 10 years ago. This is the same tainted drug allegedly to blame for 23 meningitis deaths across the country.
Documents released Monday, as well as testimony before a congressional committee, suggest a pattern of violations and modest, rather than strict, penalties for the New England Compounding Center (NECC) and its owner, Barry Cadden.
WBUR's Martha Bebinger joined Morning Edition host Bob Oakes to discuss the records.
In 2002, the state learned of a bad reaction to the steroid — the same one that was tainted with a fungus this summer — and sent inspectors to NECC. What happened from there?
We're still piecing together all the events, but this appears to have been the first time that state or federal regulators learned of problems related to the production of drugs at NECC. It's not clear from the records how this complaint was resolved. By 2004, we see the state propose disciplinary action, including three years of probation. But an attorney for the company said such action would be “fatal” for the company, and the state agreed to a series of changes, with outside monitoring instead.
Then in 2006, after another inspection turned up violations including insufficient protection against contamination and no standard written guidelines for operating the equipment, state inspectors proposed a formal reprimand and a three-year probation period for the company. But the state again reached an agreement with NECC that did not result in formal disciplinary action. Why?
We don't know. What we have is the claim — or you might say another plea from the attorney for NECC — that a reprimand and a three-year probation would destroy the company’s business. This was the same year that federal regulators, the FDA, filed a warning letter with NECC. Did state inspectors accede to the company’s business plea, did they back off because NECC was helping many hospitals deal with a shortage of drugs, did inspectors question their authority? We don't know. But there was no disciplinary penalty and that meant that the problems did not have to be reported to a national pharmacy organization or to other states with which the company was doing business.
The period from 2002-2006 happens to be the years Mitt Romney served as governor. Is the Patrick administration saying that any lax oversight was Romney's fault?
No, not directly. A spokesman for the Patrick administration said that the 2006 consent agreement with NECC was "troubling, to say the least," and the state is still reviewing records related to that agreement. But of course, the most serious problems by far that have allegedly led to the deaths now of 23 people from fungal meningitis occurred under the watch of the Patrick administration.
We've been talking about records from past investigations. Is there anything in these records that explains what happened this summer, when batches of an injectable steroid were allegedly tainted with a fungus that has now caused 23 deaths and made almost 300 people sick?
No, the investigation is ongoing and there's no word on when it will wrap up. On Capitol Hill, a congressional committee began hearings Monday that are looking back at how and why NECC was allowed to mass produce steroids and other medications, in violation of its state license. The committee is also looking ahead at how laws or the authority of federal regulators should change to prevent any such future tragedies.
And what is the company saying about these past inspections and the current one? The company said in a statement that “NECC worked cooperatively with the Massachusetts Board of Registration in Pharmacy to address to the Board's satisfaction any issues the were brought to the company’s attention.”
And in response to questions about how prescriptions were filled, the company said: "NECC's intent has always been to operate in compliance with our licenses in the states where we do business, and we have made our best efforts to be in compliance with all governing laws and regulations during 15 years of providing patients with vital medications."
This article was originally published on October 23, 2012.
This program aired on October 23, 2012.
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