New Details Emerge About Company at Center of Outbreak - NECN

New Details Emerge About Company at Center of Outbreak



    NECC in Framingham, Mass. and a separate facility under same ownership are under federal investigation (Published Friday, Jan. 17, 2014)

    (NECN: Alysha Palumbo, Boston) - As state and federal health officials continue to investigate how some 17,000 steroid shots were contaminated with fungal meningitis, more is coming out about the company at the center of the deadly meningitis outbreak.

    The New England Compounding Center in Framingham, Mass. remains shut down, and now a separate compounding facility under the same ownership is under federal inspection.
    That company - Westboro-based Ameridose - released a statement Wednesday saying it, "...agreed to voluntarily and temporarily cease certain operations, including production and shipping of all products, while the Massachusetts D.P.H., the Board of Registration in Pharmacy and the F.D.A. conduct a targeted onsite inspection."

    "Ameridose and its partnering distributor Allanus Pharmaceuticals will cease distribution of all products manufactured and compounded by that company or any of the companies under shared ownership for a time delineated period," said Dr. Madeline Biondolillo, the Bureau Director for Health Care Safety and Quality at Massachusetts Department of Public Health.
    The Associated Press also reports NECC settled a lawsuit alleging it produced a tainted shot that caused a man's death in 2004, while Ameridose had a large recall of fentanyl in 2008 because it was "super potent."
    Congressman Ed Markey is pushing for increased regulation of compounding pharmacies saying NECC "...was masquerading as a compounding pharmacy so it could escape federal regulation when it was actually operating as a drug manufacturer."
    "Compounding companies fall into a black hole where neither the FDA or state pharmacy boards have the authority to oversee their work and this is why Congressman Markey's attention on this is so important because I think we do need new laws to fill in that gap," said Mass. Health and Human Services Secretary Dr. Judy Ann Bigby.
    Dr. Biondolillo says at the heart of the investigation is why NECC was producing such large batches of drugs when its license did not allow for that.
    "Our statutory and regulatory requirements stipulate that compounding can only conducted upon receipt of a patient-specific prescription," said Dr. Biondolillo.
    Ameridose says it agreed to cease certain operations as of 3 p.m. Wednesday through Oct. 22.

    That time period allowing for federal inspection can be extended or reduced through a mutual agreement between the company and the Board of Pharmacy.

    Also, we've learned the state did complete a full inspection of NECC as recently as 2011 - and the company was found in compliance with all regulations.

    An inspection from March 2012 is still ongoing.