August 22, 2013
SALEM -
When the U.S. Senate's Health, Education, Labor, and Pension Committee released it's November 2012 investigation of the fungal meningitis outbreak, it openly questioned how state and federal enforcement agencies let New England Compounding Center (NECC) continue to operate.
Photos from an onsite investigation in December revealed a poorly maintained facility, complete with a garbage dump directly outside.
The NECC was investigated on and off for more than a decade, but it wasn't until the meningitis outbreak that the company stopped producing and distributing compound drugs.
The Senate report detailed regulation and enforcement failures by the both the Food and Drug Administration and the Massachusetts Board of Pharmacy.
The NECC eventually recalled all of its drugs after multiple inspections by the FDA.
"They're now taking the action that I think they could have taken before, they just weren't paying attention to the warning signs," said Congressman Morgan Griffith (R-Salem).
He plans on introducing a bill next month that would give regulation authority for compound pharmacies to the FDA.
It's a move the agency has lobbied for and groups like the Government Accountability Office (GAO) are recommending.
"We're going to reign in these compounders that are really manufacturers and we're going to make it clear to the FDA they have the authority," Griffith said.
In a statement to WSLS 10, a spokesperson with the FDA said the new legislation is needed.
"(The) FDA must have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations."
Griffith said the bill will be bipartisan.
He expects it could be signed into law by the end of the year.
quoted from here
SALEM -
When the U.S. Senate's Health, Education, Labor, and Pension Committee released it's November 2012 investigation of the fungal meningitis outbreak, it openly questioned how state and federal enforcement agencies let New England Compounding Center (NECC) continue to operate.
Photos from an onsite investigation in December revealed a poorly maintained facility, complete with a garbage dump directly outside.
The NECC was investigated on and off for more than a decade, but it wasn't until the meningitis outbreak that the company stopped producing and distributing compound drugs.
The Senate report detailed regulation and enforcement failures by the both the Food and Drug Administration and the Massachusetts Board of Pharmacy.
The NECC eventually recalled all of its drugs after multiple inspections by the FDA.
"They're now taking the action that I think they could have taken before, they just weren't paying attention to the warning signs," said Congressman Morgan Griffith (R-Salem).
He plans on introducing a bill next month that would give regulation authority for compound pharmacies to the FDA.
It's a move the agency has lobbied for and groups like the Government Accountability Office (GAO) are recommending.
"We're going to reign in these compounders that are really manufacturers and we're going to make it clear to the FDA they have the authority," Griffith said.
In a statement to WSLS 10, a spokesperson with the FDA said the new legislation is needed.
"(The) FDA must have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations."
Griffith said the bill will be bipartisan.
He expects it could be signed into law by the end of the year.
quoted from here
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