Bigby says NECC has primary responsibility


CALLING IT “ONE of the greatest health care tragedies in my memory,” the Patrick administration’s top health official told lawmakers Wednesday that she is committed to finding out how fungal meningitis tied to tainted steroids from a Framingham company killed 32 people and infected 438 more to date.

“I know you are questioning what happened, and I am too,” Health and Human Services Secretary JudyAnn Bigby told members of three legislative committees who convened an oversight hearing to discuss industry regulation and the problems associated with the New England Compounding Center.

“These past few months have weighed heavily on me, both as the Secretary of HHS and as a doctor.” Bigby said. She said the events “have uncovered unacceptable breaches on the part of individuals, gaps in regulatory processes and above all, the need for immediate and lasting solutions.”

While acknowledging that state regulators “should have done better,” Bigby said state employees “who failed to act and displayed serious lapses in judgment” have been removed and assigned blame on NECC.

While noting “poor judgment, missed opportunities and a lack of appropriate action” by the state Board of Registration in Pharmacy enabled NECC to “continue on their troubling course,” Bigby said that NECC bears “primary responsibility” for the harm caused to patients.

She said the company “knowingly disregarded sterility tests, prepared medicine in unsanitary conditions and violated their pharmacy license, endangering thousands of lives as a result,” according to her written testimony.

Looking forward, Bigby said she’s working to identify a Department of Public Health official to address quality assurance and safety issues department-wide and suggested a retooling of professional oversight boards to include members who are free of conflicts of interest.

Gov. Deval Patrick told reporters Wednesday that the “whole story hasn’t been told” and said he is trying to show “the patience of developing the whole story and getting to the bottom of it” before making any additional changes in how the state pharmacy board operates.

The Patrick administration on Nov. 1 announced a commission to examine compounding pharmacies.

“I’m trying to get some help, that is what this commission is about, in thinking through comprehensively, so when we are ready to make a fix, and there is going to be a fix, it is comprehensive. It is one-time,” Patrick said.

Regarding the pharmacy board, Patrick said, “Most of the people on the board are pharmacists. And I’m not sure, in fact, I think they may all be. I’m not sure that strikes the right balance.” Aides said the board also includes a nurse and physician.

Patrick said “there is no doubt there are some failings here,” adding they occurred at the state level, staff level, board level, and some are systematic and will require changes to state law. “But I don’t want to do it bit by bit. I want to do it comprehensively.”

Clinton Democrat Rep. Hank Naughton, co-chair of the Legislature’s Public Safety Committee, said at the outset of the hearing, “We’re not here to call anyone on the carpet but if that’s where it leads, that where it leads.”

NECC was first licensed by Massachusetts as a pharmacy in 1998, and House Post Audit and Oversight Committee Chairman Rep. David Linksy of Natick noted that complaints against the company and its owner Barry Cadden date to as early as 2009.

“It’s amazing that the history of violations of a pharmacy operating outside its license was able to continue and the same people that were involved at NECC were applying for other licensure in subsequent years and the previous disciplinary actions were ignored,” Linsky said.

Linsky questioned whether the Department of Public Health and Board of Registration in Pharmacy had the resources to carry out its work effectively. “I am appalled, and I don’t have an answer. If it’s legislation get us legislation. If it’s a request for more resources, get us a request,” Linsky said.

Wednesday’s hearing was the first of three planned by the Committees on Public Health, Public Safety and House Post Audit and Oversight. Naughton and Linsky were joined at the start of the hearing by Public Health Committee Co-chairman Rep. Jeffrey Sanchez, and Reps. Stephen “Stat” Smith, Jennifer Benson, Jim Dwyer, Carolyn Dykema, Michael Brady, Tom Stanley, Nicholas Boldyga and Kevin Kuros.

Bigby called it “inexplicable” that the Board of Registration in Pharmacy weakened its previously agreed-to disciplinary actions in 2006 against NECC. She also said her office was concerned that many complaints against NECC over the past decade were ignored, including a July 2012 complaint lodged by Colorado over NECC exceeding the scope of its license that was never recorded or acted upon. “This raises the question of whether they could have prevented all or some of these tragic events,” Bigby said.

Dr. Madeleine Biondolillo testified that in 2004 the Board of Registration in Pharmacy voted to reprimand NECC after an investigation with the FDA related to a MedWatch report of patients reporting meningitis-like symptoms after receiving the injectable steroid methylprednisolone. The board agreed to reprimand NECC, put the company on a three-year probation and require Cadden to get additional training in sterile compounding. Neither Bigby nor Biondolillo could explain why more than a year later in January 2006 the disciplinary actions were weakened and NECC entered into a consent agreement with the board agreeing to a year of probation and to hire an independent evaluator.

“I will not be satisfied until we know the full story behind this decision,” Biondolillo said, calling it “gravely concerning” and still under investigation.

Referring to Cadden, Naughton asked, “Has anyone talked to this guy, or is he all lawyered up?” Bigby said Cadden was in Washington Wednesday to appear before Congress, and according to published reports Cadden plans to plead the 5th to avoid testifying.

Dr. Lauren Smith, the interim commissioner of the Department of Public Health, was also unable to attend Wednesday’s hearing in Boston because she was due to testify before Congress at a similar oversight hearing.

Bigby said that in the early part of the last decade professional licensure boards were transferred to DPH from the Division of Consumer Affairs and inherited a backlog of nearly 2,000 complaints and only two inspectors on staff. The Patrick administration has increased the number of pharmacy inspectors from two to five, and Bigby said that over the past several lean budget years she has advised her department heads not to propose savings that would compromise the quality of services being provided.

Meet the Author
Meet the Author

Matt Murphy

State House News Service
Meet the Author
“If there were more resources, I would think it would be more possible to do more unannounced inspections not related to complaints,” Bigby said.

Gov. Patrick has previously said current staff would be able to handle the unannounced inspections included in new emergency pharmacy oversight regulations.