Senator seeks information from FDA, Massachusetts Board of Registration in Pharmacy, and New England Compounding Center Owners
Posted on October 25, 2012
“Once the investigations are complete, we will do what needs to be done to try to make sure something like this never happens again.” – Lamar Alexander
NASHVILLE – U.S. Senator Lamar Alexander (R-Tenn.) today sought answers on the current multi-state outbreak of meningitis from the Food and Drug Administration, the Massachusetts Board of Registration in Pharmacy, and the owners of the New England Compounding Center (NECC).
“This is a tragic situation that never should have happened. It is clear that compounding pharmacies need clearer regulatory supervision. Once the investigations are complete,” Alexander said, “we will do what needs to be done to try to make sure something like this never happens again.”
Alexander, along with a bipartisan group of senators serving on the Senate Health, Education, Labor and Pensions Committee, sent letters to the FDA, Massachusetts board, and NECC owners, seeking information related to the outbreak.
The Centers for Disease Control report that 70 Tennesseans have been infected with fungal meningitis and nine Tennesseans have died as a result of the multistate fungal meningitis outbreak among patients who received contaminated steroid injections distributed by Massachusetts-based NECC.
Alexander earlier this month joined Sen. Bob Corker (R-Tenn.) in sending a letter to FDA Commissioner Margaret Hamburg asking for clarity regarding existing laws governing oversight of compounding pharmacies like NECC and information about any inspections of NECC and actions taken since the FDA warned the center in December 2006.
In today’s letter to the FDA, the senators write that the committee has questions “about how large quantities of contaminated drugs were distributed throughout the country, particularly given that the investigation has now expanded to include two additional drug companies with the same ownership as NECC, Ameridose, LLC (Ameridose), and Alaunus, LLC (Alaunus).”
The senators’ letter to the Massachusetts Board of Registration in Pharmacy requests information “regarding the Board’s interactions with the pharmacy in question, in order to better understand the circumstances that led to the present outbreak,” the letter states.
In their letter to the NECC, the senators write: “We are seriously concerned about the current public health crisis involving hundreds of cases of fungal meningitis and other types of infections that has been linked to drugs produced by the New England Compounding Center (NECC). We are writing to request information that will enable us to better understand how one or more drugs compounded by NECC became contaminated with fungi before distribution throughout the country.”
Copies of all three letters are attached to this release.
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