Published October 16, 2012
Dow Jones Newswires
Criminal investigators from the U.S. Food and Drug Administration Tuesday
searched a Massachusetts pharmacy said to have made drugs tied to a meningitis
outbreak that has killed 15 people.
The search comes a day after the FDA identified two new drugs produced by the New England Compounding Center which may have infected patients with the rare form of fungal meningitis.
"This is part of our ongoing investigation...to fully investigate the scope and cause of the outbreak of fungal meningitis," FDA spokeswoman Sara Clark-Lynn said.
Ms. Clark-Lynn declined to say if criminal charges were pending or confirm if criminal investigators were part of the team.
The Boston Globe published pictures on its website of people outside NECC wearing blue "FDA OCI" jackets--FDA's Office of Criminal Investigations.
The outbreak has led to calls for tighter regulation of the loosely controlled pharmaceutical-compounding industry.
Critics say drug manufacturers have found a way to sidestep costly and strict oversight by classifying themselves as pharmacies. Pharmacies have freer rein to mix drug compounds.
Nearly 14,000 people in 23 states were at risk after three lots of a steroid produced by NECC were contaminated with fungus. The drug is commonly injected into the spine to treat back pain.
The FDA hasn't determined how many people are at risk from other potentially tainted NECC drugs, but said the sterility of the facility's products is "of significant concern."
"During our thorough investigation, FDA has taken samples of compounded products, is reviewing the facility's compounding protocols, ascertaining from the firm where the products were sent, whether valid prescriptions were in place, analyzing samples submitted by clinics and health-care professionals, and looking to determine what active pharmaceutical ingredients were used to produce the products," Ms. Clark-Lynn said.
The company was warned by the FDA in 2006 that its practices were violating rules, and is also been under investigation by state authorities.
Read more: http://www.foxbusiness.com/news/2012/10/16/investigators-search-us-pharmacy-linked-to-outbreak/#ixzz29WCTwswd
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