Investigators from the U.S. Food and Drug Administration and the Massachusetts Department of Public Health said they observed many serious deficiencies and significant violations of law and good compounding practices at the New England Compounding Center in Framingham, Mass., dating back more than 10 years.
Besides the 32 fatalities, there have been 438 confirmed cases of fungal meningitis in 19 states among about 14,000 patients administered drugs from NECC. The Massachusetts company has recalled all products made at its Framingham facility.
The U.S. House of Representatives' Energy and Commerce Committee's Subcommittee on Oversight and Investigations released a 25-page report on the history of NECC's regulatory issues in advance of a public hearing Wednesday in Washington titled "The Fungal Meningitis Outbreak: Could It Have Been Prevented?"
"Some of the violations observed by regulators as early as 2002 include the company's failure to maintain adequate safeguards for sterile injectable products -- the very issue at the center of the current meningitis outbreak," the report said.
"The FDA conducted three prior series of inspections of NECC, each based on a separate set of allegations or events in 2002 and 2003 and one warning letter in 2006. The Massachusetts Board of Pharmacy has an even more extensive history with NECC. Prior to the current outbreak, the board had investigated at least 12 separate complaints concerning NECC or Barry Cadden, the managing pharmacist and later the president, issued at least four advisory letters and/or informal reprimands, and entered into a consent agreement with the company in 2006."
On June 27, 2001, the Massachusetts board's staff completed an investigation into a report submitted by the Idaho Board of Pharmacy that NECC was soliciting business for drug products that should have been discontinued by the manufacturer.
In addition, on April 18, 2002, the Massachusetts board received a letter from the Nevada Board of Pharmacy describing allegations of NECC selling non-FDA-approved products to physicians in Nevada, the report said.
Further, based on various complaints of unprofessional conduct and failure to adhere to standards of practice between 2002 and 2004, the Massachusetts board issued three advisory letters to Cadden and NECC on Sept. 30, 2004. Each of the advisory letters addressed complaints made by out-of-state pharmacists or practitioners in Texas, South Dakota, Iowa and Wisconsin.
In March 2002, two adverse events were reported to the FDA via its MedWatch system, involving epidural betamethasone repository injections. Betamethasone acetate and betamethasone sodium phosphate suspension were from the same lot compounded and distributed by NECC. Like methylprednisolone acetate -- the steroid linked to the current meningitis outbreak -- betamethasone repository injections are steroid solutions often used to treat pain and swelling.
The FDA alerted the Massachusetts board and invited the agency to participate in an inspection on April 9, 2002. FDA noted in its investigative report that the agency had no previous investigation or inspection history with the firm, though the board had inspected NECC in the past.
FDA investigators reported problems found at a California compounding pharmacy associated with numerous hospitalizations and three fatal cases of meningitis were "very similar" to those encountered at NECC.
The first day of the inspection, Cadden was cooperative, but the next day he refused to provide additional information and challenged the FDA's jurisdiction and authority, the report said.
In February 2003, the Massachusetts board filed formal complaints against NECC and Cadden for "failure to adhere to standards of practice for compounding prescriptions."
"Specifically, the pharmacy and pharmacist engaged in unprofessional conduct as exhibited by: failing to follow guidelines, sterility procedures, record keeping requirements, batch records and failing to provide certificates of analysis, proof of sterility testing, Endotoxin test results, batch numbers and prescriptions upon request," the board alleged.
The committee report noted after closing out the inspection report and convening the meeting with state officials, FDA's primary NECC investigator and her supervisor recommended "NECC be prohibited from manufacturing until they can demonstrate ability to make product reproducibly and dependably."
It was agreed the state would ask Cadden to appear before the Massachusetts board to answer to the current complaints.
Susan Manning, the board's counsel, said Massachusetts pharmacy law states pharmacists must act in accordance with the recommendations of the U.S. Pharmacopeia, a scientific non-profit organization that sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements manufactured, distributed and consumed worldwide. In addition, she stated although the state's authority does not include the ability to fine pharmacists, the state could suspend or revoke a pharmacy's license, the report said.
The FDA said it generally defers to state regulators as long as a firm's operations fall within the scope of a pharmacy.
The state board did not commence any regulatory actions until Sept. 21, 2004, when it voted in favor of proposing a consent agreement to NECC and Cadden to resolve the complaints and violations. A letter two weeks later stated if NECC and Cadden chose not to enter into the consent agreement the board would proceed to a formal hearing, but there is no documentation any such hearing occurred, the report said. However, on Jan. 6, 2006, NECC and Cadden did sign a consent agreement with the board -- which included a formal reprimand and a three-year probationary period.
However, the NECC and the board eventually agreed to only a probationary period of one year. Why NECC was able to decrease the penalty was still being investigated, the report said.
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