'Meningitis' pharmacy had many violations

Published: Nov. 13, 2012 at 10:27 PM

WASHINGTON, Nov. 13 (UPI) -- U.S. health officials say a six-week investigation found the pharmacy linked to the meningitis outbreak that killed 32 people has a long history of violations.

Investigators from the U.S. Food and Drug Administration and the Massachusetts Department of Public Health said they observed many serious deficiencies and significant violations of law and good compounding practices at the New England Compounding Center in Framingham, Mass., dating back more than 10 years.

Besides the 32 fatalities, there have been 438 confirmed cases of fungal meningitis in 19 states among about 14,000 patients administered drugs from NECC. The Massachusetts company has recalled all products made at its Framingham facility.

The U.S. House of Representatives' Energy and Commerce Committee's Subcommittee on Oversight and Investigations released a 25-page report on the history of NECC's regulatory issues in advance of a public hearing Wednesday in Washington titled "The Fungal Meningitis Outbreak: Could It Have Been Prevented?"

"Some of the violations observed by regulators as early as 2002 include the company's failure to maintain adequate safeguards for sterile injectable products -- the very issue at the center of the current meningitis outbreak," the report said.

"The FDA conducted three prior series of inspections of NECC, each based on a separate set of allegations or events in 2002 and 2003 and one warning letter in 2006. The Massachusetts Board of Pharmacy has an even more extensive history with NECC. Prior to the current outbreak, the board had investigated at least 12 separate complaints concerning NECC or Barry Cadden, the managing pharmacist and later the president, issued at least four advisory letters and/or informal reprimands, and entered into a consent agreement with the company in 2006."

On June 27, 2001, the Massachusetts board's staff completed an investigation into a report submitted by the Idaho Board of Pharmacy that NECC was soliciting business for drug products that should have been discontinued by the manufacturer.

In addition, on April 18, 2002, the Massachusetts board received a letter from the Nevada Board of Pharmacy describing allegations of NECC selling non-FDA-approved products to physicians in Nevada, the report said.

Further, based on various complaints of unprofessional conduct and failure to adhere to standards of practice between 2002 and 2004, the Massachusetts board issued three advisory letters to Cadden and NECC on Sept. 30, 2004. Each of the advisory letters addressed complaints made by out-of-state pharmacists or practitioners in Texas, South Dakota, Iowa and Wisconsin.

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'Meningitis' pharmacy had many violations