The New England Compounding Center has a long history of run-ins with state, federal and independent authorities, beginning just 10 months after its 1998 opening, according to a report by the U.S. Senate's Health, Education, Labor and Pensions (HELP) Committee. Now the FDA is under scrutiny for its slow response to the initial inspections, taking 2 years to send a 2006 warning letter to Barry Cadden, RPh, NECC's director of pharmacy and part-owner.
The first enforcement action against NECC, for "including blank prescriptions in solicitations to practitioners, a practice that violated [Massachusetts] law," was resolved when the Massachusetts Board of Registration in Pharmacy issued "a warning ... in a private non-disciplinary advisory letter," according to the HELP report.
The FDA first inspected NECC in 2002, when the same drug at issue in the current outbreak - methylprednisolone acetate - was a suspected cause of at least 2 cases with bacterial meningitis-like symptoms. Although the samples tested sterile at the time, an FDA employee told the Massachusetts pharmacy board that, "Sterilization techniques and aseptic practices continue to raise questions, despite no positive (nonsterile) results from latest samples," says the HELP report.
In a majority memorandum, the U.S. House of Representatives Committee on Energy and Commerce detailed the exceptionally long delay between the FDA's inspection of NECC in 2004 and its issuing of a warning letter on December 4, 2006. The letter detailed 4 "primary areas of NECC activity that constituted violations of the [Food, Drug, and Cosmetic Act] for which the agency would not exercise its enforcement discretion," according to the memo.
Mr. Cadden's Jan. 5, 2007 reply to the FDA opened by noting "the Warning Letter is based on an inspection of NECC that started on September 23, 2004, approximately twenty-eight months ago ... FDA has not contacted us since concluding the inspection. Some of the letter's assertions no longer apply to NECC's operations."
His letter claimed that NECC didn't "compound copies of FDA-approved commercially available drugs, introduce unapproved new drugs into interstate commerce ... process or repackage approved drugs" and didn't need FDA approval to dispense its compounded formulations, according to the memo. Further, Mr. Cadden wrote, "Nor are our compounded medications misbranded. NECC dispenses compounded medications upon the receipt of valid prescriptions."
The FDA failed to respond again until Oct. 31, 2008, with a letter that apologized for the correspondence delays and noted the agency was still concerned with NECC's production. According to the memo, the FDA wrote, "Your firm must promptly correct the violations noted in the December 4, 2006, Warning Letter, and establish procedures to assure (sic) that such violations do not occur. Its failure to do so may result in enforcement action including seizure of the firm's products and/or an injunction against the firm and its principals." The letter promised a future inspection, but this follow-up, 4 years after the inspection in question, "is the last documented correspondence between FDA and NECC until the recent outbreak."
The House Energy and Commerce Committee's Oversight and Investigations Subcommittee is now pressing the FDA to release more documentation regarding its interactions with NECC, according to a press release. As Rep. Cliff Stearns (R-Fla.), the subcommittee chair, wrote on the committee's blog, "The FDA's spotty history with the NECC dates back to 2002, when state and federal regulators initially found contaminated drugs. FDA Commissioner Hamburg [has] repeatedly asserted that the FDA lacked the necessary authority to do so. ... If the FDA had the authority to shut down the NECC in October of this year, why didn't it assert its authority in 2006?"
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