On the recordNovember 18, 2013
Mr. President, the Senate is poised to pass legislation aimed at strengthening the safety of compounded pharmaceuticals and the security of the drug supply chain. It has been more than 1 year since the public became aware of what quickly became a far reaching fungal meningitis outbreak affecting citizens in 20 States, including my home State of Michigan. Following an investigation by the Centers for Disease Control and Prevention and the Food and Drug Administration, along with local health departments, it became clear the outbreak was caused by contaminated steroid injections produced by the now defunct New England Compounding Center, NECC, a compounding pharmacy in Framingham, MA. This tragedy brought a spotlight to bear on the opaque regulation of mass compounding pharmacies. According to the CDC, over 750 people from across the United States were affected by tainted pain steroid injections produced by NECC. Victims numbering 264, more than one third of the hundreds made severely ill from contaminated injections, reside in Michigan. Sixty- four of the victims lost their life as a result of illness, including 19 Michiganians. While it is certainly important that we clarify Federal regulatory responsibilities to help ensure similar tragedies are not repeated in the future, we could have begun debate on a solution far earlier. A legislative response is surely long overdue.…
Source
govinfo.gov




