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Records: FDA didn't issue meningitis warning for 684 days

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By Reuters
Wednesday, Nov. 21, 2012, 6:10 p.m.
 

BOSTON — The Food and Drug Administration took 684 days to issue a warning letter after uncovering infractions that potentially could harm patients of the pharmacy at the center of the deadly meningitis outbreak, according to newly released documents.

The New England Compounding Center chastised the FDA in a letter dated Jan. 5, 2007. The center told the agency that its response time was nearly 18 months longer than the FDA's average response, according to letters released under an open-records request.

“We believe that FDA's nearly two-year delay in issuing the Warning Letter contradicts FDA's rhetoric regarding the asserted risks associated with our compounded products,” center co-owner and chief pharmacist Barry Cadden said in the letter, released by the FDA under an open-records request.

The FDA acknowledged in a letter to Cadden dated Oct. 31, 2008, that there had been a “significant delay” in its response but insisted that the delay “in no way diminishes our serious concerns about your firm's operations.”

The FDA has asked lawmakers to clarify its authority to oversee large-scale drug compounders such as NECC. But several Republicans have argued that the agency has the authority that could have prevented the outbreak.

According to the Centers for Disease Control and Prevention, 34 people have died and 490 have been harmed after Framingham, Mass.-based NECC shipped a tainted steroid — methylprednisolone acetate — to medical facilities throughout the United States. The steroid is typically used to ease back pain.

The national outbreak stretched to two clinics in Pennsylvania, where officials reported one case of fungal meningitis at Allegheny Pain Management in Altoona. A second clinic in the Pittsburgh area that received tainted medication, South Hills Pain and Rehabilitation Associates, did not report any cases of the illness.

— Trib Total Media contributed to this report

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