Massachusetts Health Chief Cans Coffey Over Meningitis Outbreak


Posted on 10th November 2012 by gjohnson in Uncategorized

, , , , , ,

This certainly took long enough to happen: The Massachusetts Department of Health has booted James Coffey, the director of its pharmacy board.

Coffey’s apparent incompetency may have contributed to a meningitis outbreak that has killed more than 30 people and made hundreds of others ill. Coffey was canned Wednesday for not following up on a complaint from the Colorado Pharmacy Board against the New England Compounding Center (NECC), which is the source of the steroids that were contaminated by a fungus and proved deadly.

Massachusetts Department of Public Health (DPH) Interim Commissioner Dr. Lauren Smith made the announcement Wednesday.

“We have discovered a Colorado Board of Pharmacy complaint against NECC, which was forwarded to James D. Coffey, Director of the Massachusetts Board of Pharmacy, on July 26,” the press release said.

“The information shared by Colorado showed that NECC had distributed manufactured drugs to many hospitals in that state between 2010 and 2012 without patient–specific prescriptions, in violation of NECC’s Colorado and Massachusetts licenses,” the statement said.

“”The Colorado Board of Pharmacy contacted the FDA who confirmed that NECC was not a licensed manufacturer. As seen in the attached documents, this information was provided in detail by Colorado to Mr. Coffey in July, which he then forwarded to Boa rd attorney Susan Manning and Board inspectors.”

“The director of the Board is responsible for ordering investigations,” Smith said in her statement. “Mr. Coffey failed to order an investigation or take any other action on the Colorado complaint. 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.”

“Following the outbreak, staff also failed to disclose the existence of Colorado’s complaint to leadership at DPH,” Smith said. “As a result of these findings, we have terminated James Coffey and placed Susan Manning, a member of a bargaining unit, on administrative leave pending the final conclusions of our investigation. We have identified highly qualified individuals to fill these positions and the important work of the agency will continue with even greater resolve at this critical juncture.”

Smith didn’t mince words.

“I find the actions of NECC reprehensible,” she said. “We have the right to expect that all companies producing medication for use in delivering health care to comply with laws designed to protect patient safety. But I also expect the staff charged with oversight to perform their duties to the highest standards. That failed to happen here.”

Summing up, Smith said, “Since starting as interim commissioner, I have promised and delivered swift and decisive actions. This investigation and the Department’s 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.”

Coffey is one of the witnesses who has been called to testify as part of an investigation into the meningitis outbreak. The U.S. House Energy and Commerce Committee has said that the Subcommittee on Oversight and Investigations will convene a hearing next week, on Nov. 14.

One of the other witnesses called to appear was Barry Cadden, Director of Pharmacy and NECC owner. He indicated that he would not appear, and was promptly subpoenaed.

Congress Issues Subpoena, Sets Nov. 14 Hearing On Meningitis Outbreak


Posted on 7th November 2012 by gjohnson in Uncategorized

, , , , , , , , , ,

Maybe Washington is going to actually to crack down on compounding pharmacies, the apparent culprits in a fungal meningitis outbreak that has killed more than two dozen people.

Continuing its investigation of the public health tragedy, U.S. House Energy and Commerce Committee leaders this week announced that the Subcommittee on Oversight and Investigations will convene a hearing on Nov. 14.

In its original press release, the subcommittee said it had also invited James Coffey, Director of the Massachusetts Board of Registration in Pharmacy, and Barry Cadden, Director of Pharmacy and owner of the New England Compounding Center (NECC), to appear at the hearing. That is the facility that was the source of a tainted steroid that had caused deaths and sickened hundreds of people.

Although Cadden was invited, he apparently didn’t want to come. So on Tuesday House Energy and Commerce Committee Chairman Fred Upton, after consulting with ranking member Henry Waxman, issued a subpoena for  Cadden to testify at next week’s hearing.

“Through his counsel, Cadden has declined to appear voluntarily,” the committee said in a press release.

Upton and Waxman also issued a joint statement.

“With more than 400 people infected and 30 deaths, it is critical that we hear directly from the head of the facility linked to the outbreak,” they said. “Since Mr. Cadden has indicated he will not appear voluntarily, we are left with no choice but to issue a subpoena. We urge Barry Cadden to put the public health first and answer the committee’s questions about the deadly outbreak.”

FDA Commissioner Margaret Hamburg is also scheduled to testify next week. Apparently, she didn’t have to be subpoenaed.

Upton,  Waxman, Subcommittee Chairman Cliff Stearns, and Subcommittee Ranking Member Diana DeGette put out a joint statement Monday.

“Our committee has a long, bipartisan history of conducting drug safety oversight,” they said.

“Since the meningitis outbreak, we have been in close contact with the involved agencies and parties, but many unanswered questions remain. The NECC has a history of problems, some of which were documented in an FDA warning letter in 2006 – we want to know what went wrong at this facility, the views and actions of its regulators, and what steps can be taken to ensure such an outbreak never happens again.”

The FDA has virtually no authority over compounding pharmacies, a situation that several lawmakers want to remedy with new legislation,