State Officials Sift For Answers At NECC Hearing
While the New England Compounding Center was able to avoid harsher penalties in 2006 for producing contaminated steroids similar to those linked to a deadly meningitis outbreak, state officials are still unsure who made the decision to relax the sanctions recommended by the state pharmacy oversight board.
Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality, testified before lawmakers on Wednesday that "troubling questions remain about what influenced the more lenient consent agreement resolution."
"I will not be satisfied until we know the full story behind this decision," she said.
Two members of the Board of Registration in Pharmacy, however, said the decision was made "above us," and board President James DeVita said, "Even though it was a lesser sanction, they were going to subject themselves to this evaluation and I thought it was an opportunity to improve their overall performance."
New England Compounding Center has been linked to tainted injectable steroids that have caused the deaths of 32 people in 19 states and sickened 461 patients. NECC co-owner Barry 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 Rep. Harold Naughton, co-chair of the Committee on Public Safety.
In Boston, House lawmakers were conducting a similar oversight hearing with state officials attempting to ascertain how NECC was able manufacture large qualities of drugs in apparent violation of its state license, and how red flags about the sanitation of the Framingham lab might have been missed by inspectors and regulators.
DeVita offered lawmakers his own take on areas where regulations and laws could be tightened to prevent a repeat of what happened at NECC.
DeVita recommended sufficient state resources be allocated to "support routine unannounced inspections of all pharmacies in Massachusetts," better workforce training for inspectors, clear definitions of manufacturing and compounding, a new license for drug compounders, a national accreditation process for compounding pharmacies, and mandated random testing of products to verify sterility, potency and other characteristics.
Samuel Penta, supervising inspector at the Board of Registration in Pharmacy, and Leo McKenna, the quality assurance coordinator, noted that resources have been stretched thin, preventing inspectors from being as proactive as they could be, and instead responding mostly to complaints.
"At this time we have additional resources, but in past years leading up to this it was very difficult," Penta said.
The Patrick administration prior to the crisis boosted the number of pharmacy inspectors from two to five, but five more temporary inspectors have been added to carry out unannounced spot checks at the 25 compounding labs in Massachusetts ordered under emergency regulations.
Asked if inspectors could use more training on the intricacies of drug compounding, Penta said, "Absolutely." He also suggested pharmacies might need more staff training, or a microbiologist to monitor sterility and other procedures and inspectors need better partnership with federal authorities.
The FDA is considering taking over oversight of compounding pharmacies, as they have control over drug manufacturers.
During more than three hours of testimony before a joint hearing of three House committees on Wednesday, public health officials painted a picture of a pharmacy that appeared to try a fill a void in the commercial market by producing sterile injectable steroids used to treat pain, and at the time produced only by Pfizer.
NECC, however, was not licensed to produce drugs in large quantities for generic use, instead limited by its license to compounding for specific patient prescriptions. Drug manufacturers fall under Food and Drug Administration oversight, while compounding pharmacies are regulated by the state.
Naughton called that gap a "wasteland of the law," and said he was troubled that companies like NECC do their own quality control and until the issuance of emergency regulations were not required to report actions taken against them in other states.
One example of this was the cease and desist order issued by Colorado against NECC for shipping drugs to that state in violation of its compounding licenses. Health and Human Services Secretary JudyAnn Bigby and Biondolillo suggested the Colorado complaint, along with others against NECC over the years, went unaddressed by pharmacy board staff.
James Coffey, the director of the board, has been dismissed since the meningitis crisis started to unfold.
Biondolillo said she was not aware of any other instances aside from the case with Colorado "where there were deliberate disregard of complaints."
Asked whether the public should have trust in the Board of Registration in Pharmacy, Biondolillo said, "We have worked very hard to put in place appropriate measures so that the public can trust the Board of Registration in Pharmacy," adding that some actions taken by support staff "clearly was inadequate and we have serious questions about the judgment that was used."
In response to a question from Rep. Michael Brady, Biondilillo also said the state was closely monitoring whether the closure of NECC would have an impact on the availability of certain drugs for patients.
In October of 2002, the pharmacy board and the Food and Drug Administration initiated an investigation into complaints about an injectable steroid medication that had caused meningitis-like symptoms in some patients. Lab tests showed inaccurate potencies of compounded drugs produced by NECC and bacteria contamination in one lot of the drug.
By 2004, board inspectors determined that NECC had rectified its problems with sterility, safety and quality, but new complaints from Wisconsin about another drug had surfaced. The board voted in September 2004 to reprimand NECC, apply a three-year probation, and require Cadden to receive additional training in compounding sterility.
NECC appealed the decision, but their appeal was denied by the board, DeVita said, and the case was referred to department counsel for resolution. DeVita said more than a year later the board received a letter from attorney Nancy Dolberg, still on staff at DPH, informing them that an agreement had been reached on one year of probation stayed pending NECC's work to improve with an independent evaluator. The board's staff picked Pharmaceutical Systems Inc, whose owner had been indicted for defrauding the FDA, but the board was not informed of this information.
"This was the decision that was made above us. I just want that to be clear," pharmacy board member Karen Ryle said. After the hearing, Biondolillo said, "Certainly that's a very concerning statement that we will follow up on."
Ryle also said she did not know who put Cadden on a 2002 task force she led looking at compounding pharmacy oversight. The task force's recommendations were never adopted by DPH, and Ryle said she was unaware at the time of past disciplinary actions taken against Cadden.
"He was very knowledgeable. He was compassionate about compounding," Ryle said.
Prior to the start of the hearing, Attorney General Martha Coakley had a letter delivered to Sanchez and Senate Public Health Committee Chairwoman Sen. Susan Fargo stressing the importance of updating the state's corporate manslaughter laws, which currently allow for a fine up to $1,000 and have not been amended since 1819.
Coakley said she supports a bill (H 2849) sponsored by Rep. Eugene O'Flaherty and Sen. Bruce Tarr that would increase the penalty to $250,000. "We understand that there is no amount of money that can compensate for the loss of an individual's life. However, $1,000 is a woefully inadequate penalty and not a meaningful deterrent," Coakley wrote.
After the hearing, Naughton said he supports the bill, which is in the House Committee on Bills in Third Reading.
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