State pharmacy regulators on at least two occasions in the past decade displayed indifference in their oversight of a troubled Framingham specialty pharmacy that has now been blamed for a national fungal meningitis outbreak, according to documents obtained by the Globe Tuesday.
At the same time state and federal regulators were investigating New England Compounding Center for problems with sterile drug preparation, the company’s lead pharmacist, Barry Cadden, was chosen to serve on a state pharmacy board task force to write new rules for compounding pharmacies.
Cadden, who also co-owns New England Compounding, was appointed in June 2002, two months after the Food and Drug Administration and the pharmacy board began looking into complaints about his company — now blamed for the outbreak that has killed 32 and sickened more than 400.
The documents also show that three top pharmacy board administrators learned in 2006 that an Illinois company chosen to monitor New England Compounding was led by a man convicted of fraud involving a product blamed for blinding people. But the officials apparently did not tell board members before they voted the following month to accept the Illinois firm’s findings that New England Compounding had made satisfactory improvements.
The revelations come as lawmakers convene hearings Wednesday in Washington and on Beacon Hill to investigate the causes of the meningitis outbreak and whether it could have been prevented. Cadden has been subpoenaed to testify before the US House Committee on Energy and Commerce, Oversight and Investigations Subcommittee .
The FDA began investigating Cadden’s company in April 2002, in response to reports of dizziness, shortness of breath, and a sudden drop in blood pressure suffered by about five patients treated with an injectable steroid made by New England Compounding, according to a memo prepared by the House committee staff.
That memo says the FDA invited the Massachusetts Board of Registration in Pharmacy to join in the investigation, and that Cadden, after initially cooperating, stopped answering questions and providing records.
But that didn’t keep the state from inviting Cadden to join three other compounding pharmacists on the panel that would draft rules for their industry.
Precisely who chose Cadden is unclear, and the 99 pages of documents on the task force, released under the state open records law, do not reflect his role in the committee’s work.
Harold Sparr, president of the board at the time, said in an interview and follow-up e-mail that he appointed fellow board member Karen Ryle to chair the task force and that she chose the pharmacists for the group.
But Ryle, an associate chief of pharmacy at Massachusetts General Hospital and a current board member, said in a statement that she did not choose the task force members. She added that they “were chosen for their knowledge and experience in the field” but did not say who picked them. She declined to be interviewed.
Ryle is slated to testify Wednesday before three state House leaders.
Records show that Ryle’s task force met for more than a year and drafted rules that were later weakened after industry complaints, but never adopted.
The task force initially proposed extensive testing of drugs for contamination and potency before they could be sold, and also stipulated that compounders could produce drugs only for individual patients. But the International Academy of Compounding Pharmacists, a trade group, objected to these and several other proposals, citing the “prohibitive” costs of end-product testing. The final draft from the task force dropped these provisions.
Ryle said her task force submitted its draft regulations to the state public health department in 2003, but that US Pharmacopoeia, a nonprofit that sets drug industry standards, was revising its regulations regarding compounding pharmacies at that time.
“These regulations were moving along toward implementation, and they would supersede the regulations that we had drafted, so the work we had been doing went no further,” Ryle said.
The Globe previously reported that Illinois-based Pharmacy Support Inc. was chosen by the Massachusetts pharmacy board in January 2006 to review operations at New England Compounding.
The board was responding to several complaints that New England Compounding was mass-producing drugs and operating like a manufacturer, in violation of its state license. Those complaints included the 2002 report of patients suffering health problems.
It had been unclear whether the board at the time was aware of the legal troubles of Ross Caputo, who founded Pharmacy Support Inc. after being indicted in federal court in 2003.
Newly released documents show that the board’s attorney saw a news story about Caputo’s conviction from a Chicago newspaper in April 2006 — a month before the pharmacy board voted to accept Pharmacy Support’s findings that New England Compounding had met the requirements of a consent agreement, which helped the Framingham company avoid a one-year probation.
An April 24, 2006, e-mail from board attorney Susan Manning about New England Compounding issues included an attachment labeled “2 guilty of selling bad sterilizers to hospitals.”
The attached article detailed Caputo’s conviction for fraud involving the marketing of faulty sterilization equipment by another company that he formerly ran.
Manning sent the e-mail to Jean Pontikas, director of the Massachusetts Division of Health Professions Licensure, board executive director Charles Young, and assistant director James Coffey, but the head of the agency that oversees the pharmacy board said the board was apparently never informed.
“We have found no evidence to indicate that the Executive Director or staff attorney of the Board provided this crucial information to the Board,” Dr. Lauren Smith, interim commissioner of the Department of Public Health, says in testimony prepared for the US House hearing Wednesday.
A spokesman for the administration of Governor Deval Patrick said Tuesday that Pontikas was placed on administrative leave last Thursday.