House lawmakers went another round with the chief U.S. drug regulator Tuesday over a deadly meningitis outbreak and how federal authorities should oversee the category of pharmacy that produced it.
Food and Drug Administration (FDA) Commissioner Margaret Hamburg pleaded with lawmakers for more authority to regulate firms like the New England Compounding Center (NECC), which produced the tainted steroid injections that have killed 53 and sickened more than 700 since last fall.
Compounding pharmacies traditionally operate on a small scale by reprocessing drugs for individual patients with special needs. Some, like the now-shuttered NECC, pose challenges for regulators by creating and shipping specialty medications in mass quantities, akin to drug manufacturers.
Read more: http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/294191-lawmakers-grill-fda-chief-over-meningitis-outbreak#ixzz2QeW34KeL
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Food and Drug Administration (FDA) Commissioner Margaret Hamburg pleaded with lawmakers for more authority to regulate firms like the New England Compounding Center (NECC), which produced the tainted steroid injections that have killed 53 and sickened more than 700 since last fall.
Compounding pharmacies traditionally operate on a small scale by reprocessing drugs for individual patients with special needs. Some, like the now-shuttered NECC, pose challenges for regulators by creating and shipping specialty medications in mass quantities, akin to drug manufacturers.
Read more: http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/294191-lawmakers-grill-fda-chief-over-meningitis-outbreak#ixzz2QeW34KeL
Follow us: @thehill on Twitter | TheHill on Facebook
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