Massachusetts Health Chief Cans Coffey Over Meningitis Outbreak

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Posted on 10th November 2012 by gjohnson in Uncategorized

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

http://www.mass.gov/eohhs/docs/dph/quality/boards/pharmacy/121107-statement-from-lauren-smith.pdf

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.

http://energycommerce.house.gov/press-release/committee-schedules-hearing-deadly-meningitis-outbreak

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

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Posted on 7th November 2012 by gjohnson in Uncategorized

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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.

http://energycommerce.house.gov/press-release/committee-schedules-hearing-deadly-meningitis-outbreak

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.

http://energycommerce.house.gov/press-release/committee-issues-subpoena-head-facility-linked-meningitis-outbreak

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,

 

Bill Looks To Regulate Pharmacies Linked To Meningitis Outbreak

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Posted on 2nd November 2012 by gjohnson in Uncategorized

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It only took 28 deaths, but our astute lawmakers in Washington are drafting legislation that would finally empower the Food and Drug Administration to regulate so-called compounding pharmacies, like the one that produced the batches of tainted steroids linked to a meningitis breakout.

According to The Wall Street Journal Friday, U.S. Rep. Ed Markey, D-Mass., was going to introduce a law mandating that compounding pharmacies, which create customized drugs, meet the same sterility and manufacturing standards as traditional pharmaceutical makers. His bill is being co-sponsored by Reps. Steve Cohen, D-Tenn., and Louise Slaughter, D-New York.

http://online.wsj.com/article/SB10001424052970204707104578093174235021886.html?mod=googlenews_wsj

Rep. Rosa DeLauro, D-Conn., also plans to sponsor similar legislation, The Journal reported. Congress is probing the fatal fungal meningitis outbreak, with a hearing scheduled for after the Presidential Election.

The brouhaha comes in the wake of 28 dying and nearly 400 made ill after receiving contaminated steroid shots, medicine manufactured by the New England Compounding Center (NECC) of Framingham, Mass. The Journal reported that on Thursday, federal health officials announced that two other NECC products had been tested and had bacteria.

Compounding pharmacies have essentially fallen through the cracks when it comes to control and safety, “governed by fragmented regulations for too long, leading to the worst public-health disaster in recent memory,” The Journal quoted Markey as saying.

As the law stands now, states are supposed to regulate compounding pharmacies, but the problem is operations like NECC have grown too large for states to effectively control, according to The Journal. And currently the FDA can inspect compounding pharmacies, but can’t make them to adhere to safe drug-manufacturing standards.

Under Markey’s proposed legislation, the FDA could regulate pharmacies “partially based on their volumes,” according to The Journal. The bill draws a distinction between pharmacies that only make small amounts of drugs for individual patients and those that manufacture large quantities for use across the nation.

 

 

Lab That Made Tainted Drug In Meningitis Outbreak Was Filthy

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Posted on 27th October 2012 by gjohnson in Uncategorized

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When the Food and Drug Administration (FDA) inspected the pharmacy company that manufactured a contaminated medicine linked to 25 deaths, what it found would make your stomach turn.

Some 83 out of 321 vials contained “what appeared to be a greenish foreign matter,” the FDA said in an eight-page report late last week. Seventeen vials from that bin contained “what appeared to be white filamentous material.” One vial had a fungus.

There was bacteria and mold in a supposedly sterile room where drugs were made. And the air conditioner was put off at night, despite the fact that temperature and humidity were supposed to be carefully controlled at the facility.

http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM325980.pdf

The New York Times did a Page One story Saturday based on the FDA’s report , called a “483,” on its inspection of the New England Compounding Center (NECC) in Farmingham, Mass. This is the company that manufactured the tainted steroid, injected as a pain killer, that allegedly caused a national outbreak of  fungal meningitis. Two dozen are dead, more than 300 are sick and possibly 14,000 were exposed to the steroid, according to The Times.

http://www.nytimes.com/2012/10/27/health/fda-finds-unsanitary-conditions-at-new-england-compounding-center.html?pagewanted=all&_r=0

“The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Mass., facility,” the federal agency said in a press release.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm325994.htm

“The investigators also observed problems with NECC’s ability to maintain its clean room, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination,” the FDA said.

“Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container.”

Finally, the press release said, “The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations. The 483 does not constitute a final FDA determination that any observation listed on the 483 is a violation of the Federal Food, Drug, and Cosmetic Act or any related regulations.”

I think it’s a pretty safe bet that the FDA will ultimately there were violations by NECC, don’t you?

The FDA said it was continuing to work the U.S. Centers for Disease Control and Prevention and state partners, including the Massachusetts Board of Registration in Pharmacy, to investigate the outbreak of fungal meningitis among patients who received NECC’s compounded preservative-free methylprednisolone acetate, an injectable steroid.

The problem with compounding centers such as NECC is that they have essentially not been regulated by the FDA, since they are not full-fledged drug makers. As The Times pointed out in its Saturday story about NECC, “Instead of producing tailor-made drugs for individual patients, as the law allowed, the company turned into a major drug maker that supplied some of the most prestigious hospitals in the country.”

The FDA report also noted that NECC “is abutted to the rear and along the left parking area by a recycling facility that handles such materials as mattresses and plastics … the area was observed to include large equipment (e.g. excavators and freight trucks) producing airborne particulates (e.g. dust). Rooftop units serving the firm’s HVAC system were estimated to be located approximately 100 feet from the recycling facility.”

What did some of the experts say about this mess?

A pharmaceutical sterility expert, Russell Madsen, when asked about the FDA’s inspection report told The Times, “In all my time in the pharmaceutical industry, which is 45 years, I’ve never seen one this bad.”