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Meningitis Outbreak
FRAMINGHAM (FOX 25 / MyFoxBoston.com) – With new cases being reported of fungal infection involving a different pain-relieving steroid manufactured by the New England Compounding Center, Congressman Edward J. Markey called on the Dept. of Justice to commence an investigation into whether the company may have violated laws and regulations related to how controlled substances can be sold.
Markey made the announcement on Tuesday.
Criminal investigators from the Food and Drug Administration also visited the NECC on Tuesday.
A spokesman for the New England Compounding Center confirms that investigators were at the company, but he had no further comment.
FDA spokesman Steven Immergut says the visit is part of the investigation into the outbreak, which has killed at least 15 people and sickened more than 200 others in 15 states. Nearly all the victims had received steroid injections for back pain.
The list of recalled NECC drug products appears to include nearly 1,000 formulations that contain controlled substances, including cocaine, morphine and ketamine, which fall under the jurisdiction of the Drug Enforcement Agency.
DEA regulations state that retail pharmacies that compound or sell controlled substances must be registered with the agency and are only permitted to sell compounds containing controlled substances directly to patients in response to a patient-specific prescription unless the pharmacy is registered with the DEA as a manufacturer/supplier.
However, the DEA has informed Rep. Markey's office that the NECC is not registered with the DEA as a manufacturer/supplier.
Media reports suggests that NECC appears to have been distributing compounded drugs that were not associated with a patient-specific prescription to healthcare facilities.
"The types of medications being compounded by NECC included controlled substances such as cocaine, morphine and ketamine and require the highest level of federal oversight," said Rep. Markey in separate comments. "We need to know if NECC violated federal law and is subject to enforcement action beyond any violations it may be subject to at the state level."
Nearly 18,000 vials of contaminated drugs from NECC have been shipped to 76 healthcare facilities in 24 states.
The New Hampshire Department of Public Health also announced on Tuesday that it had discovered two additional cases of meningitis tied to the national outbreak within the state.
The Associated Press contributed to this report.
Tuesday, October 16 2012, 05:46 PM CDT
Markey made the announcement on Tuesday.
Criminal investigators from the Food and Drug Administration also visited the NECC on Tuesday.
A spokesman for the New England Compounding Center confirms that investigators were at the company, but he had no further comment.
FDA spokesman Steven Immergut says the visit is part of the investigation into the outbreak, which has killed at least 15 people and sickened more than 200 others in 15 states. Nearly all the victims had received steroid injections for back pain.
The list of recalled NECC drug products appears to include nearly 1,000 formulations that contain controlled substances, including cocaine, morphine and ketamine, which fall under the jurisdiction of the Drug Enforcement Agency.
DEA regulations state that retail pharmacies that compound or sell controlled substances must be registered with the agency and are only permitted to sell compounds containing controlled substances directly to patients in response to a patient-specific prescription unless the pharmacy is registered with the DEA as a manufacturer/supplier.
However, the DEA has informed Rep. Markey's office that the NECC is not registered with the DEA as a manufacturer/supplier.
Media reports suggests that NECC appears to have been distributing compounded drugs that were not associated with a patient-specific prescription to healthcare facilities.
"The types of medications being compounded by NECC included controlled substances such as cocaine, morphine and ketamine and require the highest level of federal oversight," said Rep. Markey in separate comments. "We need to know if NECC violated federal law and is subject to enforcement action beyond any violations it may be subject to at the state level."
Nearly 18,000 vials of contaminated drugs from NECC have been shipped to 76 healthcare facilities in 24 states.
The New Hampshire Department of Public Health also announced on Tuesday that it had discovered two additional cases of meningitis tied to the national outbreak within the state.
The Associated Press contributed to this report.
Tuesday, October 16 2012, 05:46 PM CDT
