Wall Street Journal
October 24, 2012
Massachusetts regulators a decade ago alleged there were serious issues with the production of pain medication by the New England Compounding Center (NECC), the specialty pharmacy recently implicated in the deadly fungal meningitis outbreak, according to newly released state documents.
But the state pharmacy board backed off a proposal to issue a formal reprimand and a three-year probation after the firm’s lawyer complained in a letter that the action could “destroy their business.”
Instead, in 2006, the Massachusetts pharmacy board agreed to a milder penalty for NECC and its president, Barry J. Cadden. The revised penalty called for a consent agreement that was “nondisciplinary,” meaning it wouldn’t be reported to the National Association of State Boards of Pharmacy, which could have affected NECC’s license in other states, according to the documents.
The agreement also called for a one-year probation, which would be stayed so long as NECC adhered to the outlined changes. An NECC spokesman said Monday the company “worked cooperatively with the Massachusetts Board of Registration in Pharmacy to resolve to the board’s satisfaction any issues brought to the company’s attention.”
A spokesman for the Massachusetts health department, which regulates pharmacies, said Monday it was “looking at the events surrounding the signing of the consent agreement.” He called the decision “troubling.”
As of Monday, the rare form of meningitis had sickened 294 people who received epidural steroid pain injections produced by NECC that were tainted with fungus, mostly the exserohilum strain. Of those who took ill, 23 died of the infections, according to federal officials. An additional three people developed infections in joints where they received NECC-made injections.
Compounding pharmacies custom-mix drugs and aren’t regulated by the U.S. Food and Drug Administration (FDA) like traditional pharmaceutical companies.
The new documents show that in 2002, an inspection by the FDA and state regulators left the inspectors with concerns about record-keeping, sterility and other issues. A report says Cadden, when asked, failed to provide sterility and endotoxin test results.
Then, in October 2002, according to the documents, the FDA informed the state of an incident involving an adverse reaction to methylprednisolone acetate—the same drug later implicated in the meningitis outbreak. A state inspector in a report in 2004 called for a “formal reprimand” over the various issues from the preceding years.
In October 2004, the state board voted to resolve two investigations with a proposed consent agreement that stated NECC and Cadden had engaged in “professional misconduct” by failing to comply with accepted standards in compounding methylprednisolone acetate. It also called for a reprimand, along with placing its pharmacy registration and license on probation for three years, according to the documents.
NECC’s lawyer wrote back at the time, saying the firm had undertaken many changes. He said the consequences for the company’s licenses in 42 other states “would be potentially fatal to the business,” adding that “once disclosed, the reprimand surely will result in inquiries/investigations in those other jurisdictions.”
The attorney asked for the type of stayed probation the pharmacy board later agreed to in 2006. Under terms of the January 2006 agreement, the drug-mixing pharmacy had to undergo an inspection by an independent firm and was given 90 days to implement any recommendations unless it received an exemption. In June 2006, the state pharmacy board sent a letter to Cadden saying NECC had “satisfactorily completed the terms and conditions” of the agreement.
Meanwhile, the House Energy and Commerce Committee, which is investigating the outbreak, sent a letter to NECC’s lawyer Monday seeking documents explaining, in part, how the pharmacy kept operating “ten years after” the 2002 inspection of the sterile injections that allegedly found problems with them.
The NECC spokesman didn’t respond to a request for comment on the letter.
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