Congressman Griffith's Weekly E-Newsletter 12.2.13
Bipartisan Bill I Worked On Signed Into Law
Last week, President Obama signed into law the Drug Quality and Security Act. This win for common sense came after investigations into last fall’s fungal meningitis outbreak tied to tainted injections prepared by Massachusetts’ New England Compounding Center (NECC).
Traditional compounding pharmacies are overseen by State boards of pharmacy. They tend to be small mom-and-pop operations, and make custom medications based on a doctor’s order.
The NECC had long ago stopped operating as a traditional compounding pharmacy. Instead, the NECC was engaged in large-volume drug manufacturing without proper prescriptions.
The NECC claimed that they were exempt from oversight by the Food and Drug Administration (FDA), which typically regulates the manufacturers of medicines. Despite the NECC’s claim, I believe that the FDA clearly had the authority they needed to have regulated the NECC and prevented the fungal meningitis outbreak.
Despite having received complaints from multiple States about the NECC, the FDA did not step in to investigate NECC for illegal manufacturing or share this important information with other States. My colleague, Rep. Diana DeGette (D-CO), recently wrote that the Colorado State Board of Pharmacy in 2011 identified issues with the NECC, having determined that the drugs being distributed in Colorado lacked proper prescriptions. She continued, “Our state board issued a cease-and-desist order to the NECC, and notified the Massachusetts Board as well. But that was all it could do; ultimately, it was not enough to stop the NECC's actions and prevent the tragic outbreak that swept across the nation a year later.”
Because of this oversight failure, the NECC is reported as having shipped more than 17,600 doses of the tainted steroid injection. FDA investigators later uncovered bacteria and mold at the NECC.
But more than 750 people throughout the United States were stricken with fungal meningitis resulting from these injections. Nationwide, 64 people were tragically killed as a result. At least two of those killed were from our region, and others continue to suffer.
After hearings into the outbreak, Rep. Gene Green (D-TX), Rep. DeGette, and I began working together on a bill to further define a compounding pharmacy and clarify oversight of the compounding drug manufacturing system. In September, after months of negotiations, we introduced the Compounding Clarity Act (H.R. 3089), which would clarify FDA authority over compounding, particularly over large-scale entities like the NECC that act as drug manufacturers.
The Griffith-Green-DeGette bill served as the foundation for the compounding pharmacy inspection portion of the Drug Quality and Security Act, which the President signed into law. It is a bipartisan, bicameral first step to ensure the safety of compounded drugs and help save lives, eliminating perceived confusion as to the oversight of pharmacies like the NECC that have worked the system to skirt both FDA and State regulations.
I will continue working on areas that need additional clarification, and will oversee the FDA’s interpretation and implementation of this law.
Unfortunately, for some, the Drug Quality and Security Act is too little, too late. And as with many proposals, the bill is not perfect. But it does represent consensus and common sense. I believe it would prevent another NECC-type outbreak from occurring.
quoted from here
Bipartisan Bill I Worked On Signed Into Law
Last week, President Obama signed into law the Drug Quality and Security Act. This win for common sense came after investigations into last fall’s fungal meningitis outbreak tied to tainted injections prepared by Massachusetts’ New England Compounding Center (NECC).
Traditional compounding pharmacies are overseen by State boards of pharmacy. They tend to be small mom-and-pop operations, and make custom medications based on a doctor’s order.
The NECC had long ago stopped operating as a traditional compounding pharmacy. Instead, the NECC was engaged in large-volume drug manufacturing without proper prescriptions.
The NECC claimed that they were exempt from oversight by the Food and Drug Administration (FDA), which typically regulates the manufacturers of medicines. Despite the NECC’s claim, I believe that the FDA clearly had the authority they needed to have regulated the NECC and prevented the fungal meningitis outbreak.
Despite having received complaints from multiple States about the NECC, the FDA did not step in to investigate NECC for illegal manufacturing or share this important information with other States. My colleague, Rep. Diana DeGette (D-CO), recently wrote that the Colorado State Board of Pharmacy in 2011 identified issues with the NECC, having determined that the drugs being distributed in Colorado lacked proper prescriptions. She continued, “Our state board issued a cease-and-desist order to the NECC, and notified the Massachusetts Board as well. But that was all it could do; ultimately, it was not enough to stop the NECC's actions and prevent the tragic outbreak that swept across the nation a year later.”
Because of this oversight failure, the NECC is reported as having shipped more than 17,600 doses of the tainted steroid injection. FDA investigators later uncovered bacteria and mold at the NECC.
But more than 750 people throughout the United States were stricken with fungal meningitis resulting from these injections. Nationwide, 64 people were tragically killed as a result. At least two of those killed were from our region, and others continue to suffer.
After hearings into the outbreak, Rep. Gene Green (D-TX), Rep. DeGette, and I began working together on a bill to further define a compounding pharmacy and clarify oversight of the compounding drug manufacturing system. In September, after months of negotiations, we introduced the Compounding Clarity Act (H.R. 3089), which would clarify FDA authority over compounding, particularly over large-scale entities like the NECC that act as drug manufacturers.
The Griffith-Green-DeGette bill served as the foundation for the compounding pharmacy inspection portion of the Drug Quality and Security Act, which the President signed into law. It is a bipartisan, bicameral first step to ensure the safety of compounded drugs and help save lives, eliminating perceived confusion as to the oversight of pharmacies like the NECC that have worked the system to skirt both FDA and State regulations.
I will continue working on areas that need additional clarification, and will oversee the FDA’s interpretation and implementation of this law.
Unfortunately, for some, the Drug Quality and Security Act is too little, too late. And as with many proposals, the bill is not perfect. But it does represent consensus and common sense. I believe it would prevent another NECC-type outbreak from occurring.
quoted from here
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