Lawmakers hear differing accounts in Framingham drug company case

By Chelsea Sheasley, Metro West Daily News

BOSTON – Legislators investigating the scandal involving a Framingham pharmaceutical compounding company heard varying accounts of a decision to reject stricter disciplinary action against the firm a decade ago, with pharmacy board members testifying the ruling was made by higher ups.

But public health officials said they are still investigating to find out who is responsible for the lenient treatment.

“It was presented as this is the decision that’s been made by people above us,” Karen Ryle, the secretary of the Massachusetts Board of Registration in Pharmacy, told a legislative panel on Wednesday.

Ryle, who served as chairman of the board in 2004, spoke at hearings called by Reps. David Linsky, D-Natick, Harold Naughton, D-Clinton, and Jeffrey Sanchez, D-Jamaica Plain, to examine the Department of Public Health’s oversight of the pharmacy industry in light of the national meningitis outbreak linked to NECC that has resulted in 32 deaths and 438 illnesses so far.

But top health department officials Dr. JudyAnn Bigby and Dr. Madeleine Biondolillo, questioned the actions of the pharmacy board between 2004, when the board recommended harsh penalties against NECC, and 2006, when it signed a much weaker non-disciplinary consent agreement with NECC.

“It is inexplicable to me to try and understand what happened between 2004 when the original action was recommended and endorsed and how the consent agreement evolved,” Bigby said.

Biondolillo said that despite interviews with pharmacy board and staff members and a review of public records, a full account of how the final action came about has not emerged.

“Troubling questions remain about what influenced the more lenient consent agreement resolution, given NECC’s track record,” she said.

The U.S. Food and Drug Administration’s criminal unit is investigating the 2004 case, Bigby said.

In their testimony, Ryle and current pharmacy board chairman James DeVita gave more details about that incident.

They said that in October 2004 the board voted unanimously to sanction NECC for numerous complaints with a reprimand, three-year probation and a requirement that Barry Cadden, the company’s president, receive additional training in sterile compounding.
After NECC objected to the sanctions, the board voted unanimously again a month later to reaffirm its recommendation for disciplinary action.

According to DeVita, the board then followed normal protocol and sent the case to Nancy Dolberg, a lawyer within the Department of Public Health.

The board heard nothing about the case until a year later.

“Almost a year goes by, and we get information back that they think they can resolve this with a lesser sanction, but with this independent oversight,” DeVita said.

The independent oversight consisted of the hiring of Illinois-based Pharmacy Support Inc. for an independent review, which NECC passed in 2006. NECC was not inspected again until May 2011 when it renovated its building.

The Boston Globe reported this week that Pharmacy Support Inc. was run by a man convicted of fraud for owning a company that sold faulty medical equipment that caused blindness in 18 people. The Globe said documents show that three members of the Board of Pharmacy’s executive staff knew about the conviction, but apparently did not tell the board.

One of those staff members, James Coffey, was fired last week. Another, attorney Susan Manning, was put on administrative leave. The other staff member retired in 2006.

DeVita and Ryle told legislators that the board met monthly to review cases that were selected by full-time staff members. The Board of Pharmacy is an unpaid volunteer board.

Ryle also defended a decision to convene a task force to write compounding regulations that included Barry Cadden, co-owner of NECC.

“At the time of the task force, his business was a small business. It was definitely a mom and pop shop. It was him and his wife and a couple of employees. It wasn’t a large business at all,” Ryle said in response to legislator’s questions.

Cadden refused to testify on Wednesday when called before a congressional committee, invoking his 5th Amendment rights.

“Not surprising, not with what’s going on. He’s facing potentially serious penalties both on the state and federal level. It doesn’t surprise me at all that his attorneys have advised him to do that. Unfortunately it’s going to slow down the process of resolving this for the families of those who’ve been lost,” said state Rep. Harold Naughton, co-chairman of the House Committee on Public Safety.

Bigby suggested that a shake-up of the board with the appointment of more people unrelated to the industry could follow.

“While it is important that professional expertise be represented, there needs to be a better balance of oversight to include members who are free of conflict,” she said

All speakers at Wednesday’s hearing also called for an increase in funding to allow for unannounced inspections of compounding pharmacies and better federal and state legislation.

Rep. Linsky said he expects new legislation soon.

“There’s obviously a gap in licensing here that needs to be addressed either by state or by the federal government,” he said. “I’ll be in touch with Congressman (Edward) Markey to look at the appropriate way to deal with that going forward, but the whole situation is completely appalling.”

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