The country's top medical regulator is preparing to tell Congress that laws are needed to police large specialty pharmacies like the one at the center of a deadly meningitis outbreak.
Testimony released ahead of the first congressional hearing on the incident shows that Food and Drug Administration Commissioner Margaret Hamburg will ask lawmakers to give her agency more authority and funding to oversee compounding pharmacies.
Less than a year after it opened its doors in 1998, complaints about the New England Compounding Center began coming to the Massachusetts board that had granted it a license.
Complaints came from regulators, pharmacists and physicians from more than a half dozen states. Many were serious and warned of death or serious injury.
But, according to a 25-page congressional report, somehow the company that is now blamed in the deaths of 32 people managed to dodge state and federal regulators, who alternated between taking a hard stand and then at times inexplicably backing off.
A spokesman for the company did not respond to the report.
The report by the Republican staff of the U.S. House Committee on Energy and Commerce sets the scene for hearings Wednesday and Thursday in which state and federal regulators will be asked to explain how it all happened.
A second report from the committee's Democratic staff cites "the regulatory gap" between state and federal law in which companies like New England Compounding operate.
The hearings stem from a nationwide outbreak of fungal meningitis linked to New England Compounding's methylprednisolone acetate injected into the spines of patients seeking relief from severe spinal pain.
In a letter hand-delivered to the House committee Tuesday, an attorney for Barry J. Cadden said the part owner of the compounding firm would, with "great reluctance," be pleading the Fifth Amendment at Wednesday's hearing.
That decision "directly relates to the existence of ongoing state and federal investigations," attorney Bruce A. Singal said in the letter. "No inference should otherwise be drawn."
It was in 2004, according to the Republican report, when the Massachusetts Board of Registration in Pharmacy -- after literally years of investigation of serious health and safety rule violations -- sent a take-it-or-leave-it consent agreement letter to Cadden.
The board made clear in the letter that if the company turned down the consent agreement, the state would open formal disciplinary hearings. The agreement would have placed the company on probation for three years and included a formal reprimand.
Cadden turned down the offer in a Nov. 11, 2004, letter and offered a counterproposal. The board responded within days by voting unanimously to deny Cadden's request.
But the threat to hold formal disciplinary hearings inexplicably evaporated, according to the report.
"There is no documentation of any such hearing having occurred," the report states.
Instead, some two years later, Cadden on Jan. 6, 2006, signed a "significantly different" consent agreement with only one year's probation, and even that was stayed.
The report details similar variations in the efforts by the U.S. Food and Drug Administration, which shifted from demands that the company be shut down to a hands-off stance, ceding regulatory control to the state board.
At a Feb. 5, 2003, meeting between state and federal officials, FDA officials emphasized "the potential for serious public health consequences" if New England Compounding did not improve its practices, particularly in the handling of sterile products.
Yet at that same meeting FDA officials conceded that they would generally defer to state agencies and "seek to engage cooperative efforts."
Cadden, meanwhile, the report notes, alternated between promising to comply with all regulations on one day and refusing to even answer questions from the same FDA inspectors the very next. Put it in writing, he told them at one point, according to the report.
"The second day of the inspection Mr. Cadden had a complete change in attitude," the report states, "(and) basically would not provide any additional information."
Complaints pour in
The complaints, meanwhile, continued to come in to the FDA and the Massachusetts board. Many charged that New England Compounding was marketing and distributing drugs without patient-specific prescriptions as required by state and federal law.
Sterility and other production problems at the Framingham, Mass., facility were detailed in FDA inspection reports, including an instance in which inspectors found a container of yet-to-be-tested steroids sitting in a beaker covered with aluminum foil.
"FDA investigators discussed with Mr. Cadden that this was not an acceptable practice for maintaining sterility," the report states.
A New York hospital complained that two patients contracted meningitis-like symptoms after treatment with NECC's injections. The two, who did recover, had been injected in 2002 with the same drug blamed for the current outbreak.
In another case, the report states, Cadden flatly denied making up prescriptions in advance only to be caught in the same visit with a drawer full of 189 doses without prescriptions.
The congressional report concludes that the latest disclosures about the firm are nothing new.
"Documents produced to the committee show that NECC has a long history of very similar, if not identical, misconduct," the report states.
The Democratic report also notes how the same kinds of violations have been turned up in the latest inspections of New England Compounding and Ameridose LLC, another compounder controlled by the same owners. Like New England Compounding, Ameridose also has been shut down.