The director of the Massachusetts Board of Pharmacy allegedly knew back in July that the compounding pharmacy tied to the deadly meningitis outbreak was distributing bulk shipments of drugs to hospitals in Colorado, a clear violation of its state licenses.

But James D. Coffey failed to order an investigation of the New England Compounding Center. That lack of action cost Mr. Coffey his position on the board, Massachusetts health officials announced Wednesday. And it may have cost 31 people who've since died of meningitis they contracted from tainted drugs compounded by NECC their lives.

Colorado inspector Susan S. Martin became troubled by the lack of prescriptions for 46 hyaluronidase vials from and mismatching documentation for NECC during a routine inspection of a Colorado hospital. After pursuing further information, Ms. Martin shared her findings with Mr. Coffey. Among them:

• NECC had distributed manufactured drugs to many hospitals in Colorado between 2010 and 2012 without patient-specific prescriptions, in violation of NECC's Colorado and Massachusetts licenses.
  
• The Colorado Board of Pharmacy had contacted the FDA and received confirmation that NECC was not a licensed manufacturer.
  
• Colorado sent NECC a cease-and-desist letter in April 2011, but NECC drugs were still in facilities in July 2012.

According to the Massachusetts pharmacy board, Mr. Coffey received the 34 pages of documents on July 26, which he then forwarded to board attorney Susan Manning and board inspectors. The director of the board is charged with ordering investigations. "Mr. Coffey failed to order an investigation or take any other action on the Colorado complaint," says a statement.

"It is incomprehensible that Mr. Coffey and Ms. Manning did not act on the Colorado complaint given NECC's past, and their responsibility to investigate complaints," continues the statement. "Following the outbreak, staff also failed to disclose the existence of Colorado's complaint to leadership at [the department of public health]."

Susan Manning, a member of a bargaining unit, has been placed on administrative leave pending the outcome of the Massachusetts pharmacy board's investigation. Interim director Lauren Smith has promised that the "thorough response will not stop until we have a complete understanding of what happened, assign accountability where it is warranted and can be certain the failures that led to this tragedy never happen again." The board has already instituted stricter emergency regulations for Massachusetts compounding pharmacies.

Meanwhile, on Nov. 6, Mr. Coffey and Barry Cadden, RPh, co-owner and managing pharmacist of NECC, have been subpoenaed by the House Energy and Commerce Committee to testify before the Oversight and Investigations Subcommittee on Nov. 14. Through his counsel, Mr. Cadden has declined to appear voluntarily, says a press release.

FDA Commissioner Margaret Hamburg, MD, is also scheduled to testify. The hearing into the case, which has so far killed 31 and infected 424 patients, begins at 10 a.m. on Nov. 14 and will be webcast live here.

Stephanie Wasek