Mass. DPH: Not Clear Why Board Backed Off Penalty

The head of the Massachusetts health department said investigators still don't know why state regulators backed off a severe penalty against a pharmacy now implicated in a deadly meningitis outbreak.

Interim Commissioner Dr. Lauren Smith said "troubling questions remain" about why the New England Compounding Center escaped a penalty proposed in 2004, which included an official reprimand and probation.

The company protested that the penalty could destroy its business, and in 2006, the state's pharmacy board agreed to impose a far weaker, non-disciplinary action on the company for reasons that remain unclear.

"I will not be satisfied until we know the full story behind this decision," Smith said in a transcript of her prepared testimony, released a day ahead of delivery Wednesday before a congressional hearing in Washington. A separate hearing on the issue is also scheduled at the Massachusetts State House on Wednesday.

The fungal meningitis outbreak has spread to 19 states and killed 32 people. The sicknesses have been linked to a contaminated steroid given mainly to relieve back pain that was made by the NECC, located in Framingham.

In her testimony, Smith reviewed various dealings with the NECC since it was founded in 1998, including complaints about procedures and problems with its products' sterility and quality.

In 2002, the pharmacy board and the U.S. Food and Drug Administration investigated the NECC after complaints about two steroids it made. It's the same year that patient William Koch contracted a different form of meningitis after taking the same steroid implicated in the current outbreak. He died in 2004.

Congressional investigators said the FDA wanted to shut down the pharmacy in 2002, but it ultimately deferred to state authorities, who have jurisdiction over compounding pharmacies.

In September 2004, the state pharmacy board approved a reprimand and three years of probation for the NECC. The company objected, saying the penalty would be a "catastrophe" for the business and was unwarranted because it resolved its problems. Despite the plea, the board refused to revise the proposed consent agreement, according to its November minutes.

But by January 2006, the board had approved a non-disciplinary consent agreement with the NECC. The state hasn't been able to determine why the board abandoned the tougher agreement, Smith said.

"Despite interviews with Board and staff members involved with these decisions and a thorough review of the limited records retained from this period, troubling questions remain about what influenced the more lenient consent agreement resolution, given NECC's track record," she said.

A company spokesman had no immediate comment on Smith's testimony or why the original agreement was discarded.

Other notable aspects of Smith's testimony included:

- The NECC's co-founder and lead pharmacist, Barry Cadden, was on a Massachusetts pharmacy board task force formed in 2002 to study the board's oversight of compounding pharmacies. The task force met for nearly two years but never made formal recommendations.

- Outside evaluator Pharmaceutical Systems Inc. was retained by the NECC to inspect its compounding practices as part of the 2006 consent agreement, and pharmacy board executive director Charles Young and staff attorney Susan Manning later learned PSI executives had been convicted of defrauding the FDA and selling unapproved sterilization equipment to hospitals. But there's no evidence Young or Manning shared "this crucial information" with the rest of the board or sent inspectors back to the NECC, Smith said.

Young has retired from the board and couldn't immediately be reached for comment. Manning was placed on administrative leave this month after allegedly failing to respond to an out-of-state complaint about the NECC earlier this year. She didn't immediately respond to an email seeking comment that was sent on Tuesday.

This program aired on November 14, 2012. The audio for this program is not available.


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