The director of the Massachusetts Board of Pharmacy has been fired for failing to investigate a July complaint of the firm that's behind a 19-state fungal meningitis outbreak that has sickened 414 people as of Wednesday, 31 of which have died.
James D. Coffey, director of the Mass. Board of Pharmacy was terminated because he didn't follow-up on a complaint forwarded to him by the Colorado Board of Pharmacy on July 26, 2012, that alleged the embattled New England Compounding Center distributed compounded drugs to many Colo. hospitals 2010 and 2012 without patient-specific prescriptions, as required by the firm's Colo. and Mass. licenses.
Dr. Lauren Smith, interim commissioner of the Mass. Department of Public Health said there was evidence Coffey received the complaint, then forwarded it to Board attorney Susan Manning and Board inspectors, but he never ordered an investigation, which was Coffey's responsibility.
"It is incomprehensible that Mr. Coffey and Ms. Manning did not act on the Colorado complaint given NECC's past, and their responsibility to investigate complaints," Smith said in an emailed statement.
Compounding pharmacies mix custom medications based on an individual's prescription, and do not fall under the same federal regulation as pharmaceutical companies that manufacture drugs.
In September, the New England Compounding Center of Framingham, Mass. recalled three lots of a steroid injection commonly used to treat back pain, methylprednisolone acetate, which were shipped to 76 facilities in 23 states. Up to 14,000 people may have received the drugs, most of which have been contacted and told to get tested for fungal meningitis. At least 10 fungal joint infections have also been reported in those who received shots in areas such as the hips, knees, shoulders or elbows.
Questions of whether NECC's compounding crossed over into bulk manufacturing were discussed by company management as far back as 2009, the
"I find the actions of NECC reprehensible," said Smith. "We have the right to expect that all companies producing medication for use in delivering health care to comply with laws designed to protect patient safety. But I also expect the staff charged with oversight to perform their duties to the highest standards," she said. "That failed to happen here."
In recent weeks, a preliminary investigation by the FDA revealed questionable sterility practices at the firm, and investigators also found contamination, mold and bacterial growth where drugs were made in the facility.
On Nov. 5, The House's Energy & Commerce Committee summoned head of the Food and Drug Administration Margaret Hamburg to testify at the first congressional hearing on the issue on Nov. 14. They also had invited Barry Cadden, co-founder of the New England Compounding Center, and the recently-terminated Coffey.