WASHINGTON, Nov. 14 (UPI) --
The system failed to protect patients from preventable death from meningitis, a congresswoman from Colorado said at a hearing at the Capitol in Washington.
Rep. Diana DeGette, D-Colo., a member of the House of Representative's Energy and Commerce Committee and its Subcommittee on Oversight and Investigations, said at the hearing Congress needs to clarify the Food, Drug and Cosmetic Act, which "apparently limits the U.S. Food and Drug Administration's jurisdiction over compounding pharmacies."
"We need to make sure that for these large pharmacies have the ability to act and to act quickly on behalf of patients. In 2011, the Colorado State Board of Pharmacy determined that the New England Compounding Center was distributing unlicensed and unregistered drugs in the state and issued a cease and desist order," DeGette said at the hearing.
NECC, the compounding pharmacy in Framingham, Mass., produced about 17,000 doses of the injectable steroid methylprednisolone acetate of which some 14,000 doses were used to treat back and joint pain linked to 448 cases of meningitis and infection, killing 32.
"But this was not all the Colorado officials could do, and it was not enough to stop NECC's action. Colorado officials notified the Massachusetts Board of Pharmacy and Massachusetts did nothing," DeGette said. "The Colorado Board of Pharmacy did the right thing, but the system failed. NECC did not improve its operation. The FDA did not act, and Massachusetts did not act.
The system failed to protect patients from preventable death from meningitis, a congresswoman from Colorado said at a hearing at the Capitol in Washington.
Rep. Diana DeGette, D-Colo., a member of the House of Representative's Energy and Commerce Committee and its Subcommittee on Oversight and Investigations, said at the hearing Congress needs to clarify the Food, Drug and Cosmetic Act, which "apparently limits the U.S. Food and Drug Administration's jurisdiction over compounding pharmacies."
"We need to make sure that for these large pharmacies have the ability to act and to act quickly on behalf of patients. In 2011, the Colorado State Board of Pharmacy determined that the New England Compounding Center was distributing unlicensed and unregistered drugs in the state and issued a cease and desist order," DeGette said at the hearing.
NECC, the compounding pharmacy in Framingham, Mass., produced about 17,000 doses of the injectable steroid methylprednisolone acetate of which some 14,000 doses were used to treat back and joint pain linked to 448 cases of meningitis and infection, killing 32.
"But this was not all the Colorado officials could do, and it was not enough to stop NECC's action. Colorado officials notified the Massachusetts Board of Pharmacy and Massachusetts did nothing," DeGette said. "The Colorado Board of Pharmacy did the right thing, but the system failed. NECC did not improve its operation. The FDA did not act, and Massachusetts did not act.
Continue Reading Story here
No comments:
Post a Comment