Could The FDA Have Prevented Bacterial Infections Traced To A Compounder?
Could the FDA have prevented an outbreak of bacterial infections traced to a compounding pharmacy?
The contention was made by a consumer watchdog that notes the agency issued an inspection report last March showing that Specialty Compounding, which is based in Dallas, failed to take steps to prevent microbiological contamination, among other problems. But the agency did not issue a safety notice or pressure the company to conduct a voluntary recall.
A product recall did, however, get under way earlier this week, after the FDA after received reports of 15 bacterial infections at two Texas hospitals that were “potentially related” to the company's calcium gluconate infusions. The agency warned that any medicines that were received from the compounder since May 9 should no longer be used, quarantined and returned (read here).
However, in a letter to the Kathleen Sebelius, the secretary of the US Department of Health & Human Services, Public Citizen writes that the FDA could and should have taken action to prevent the infections after its March inspection. And the advocacy group wants Sebelius to order the HHS Office of Inspector General to investigate why the FDA did not press the compounder to conduct a recall sooner.
Moreover, the watchdog wants HHS to press the FDA to review the dozens of other compounding pharmacies that were inspected in recent months and initiate further actions against any pharmacy that was found to have sterility problems similar to those that were seen at Specialty Compounding. Public Citizen notes the FDA has issued inspection reports for 50 facilities, but only 16 have issued a recall or been the subject of an FDA enforcement action.
“The FDA knew there was a serious problem here but didn’t use its existing legal authority to take prompt, aggressive enforcement action against the company. That exposed patients to unnecessary risk and might have contributed to 15 people being infected,” says Michael Carome, who heads Public Citizen Health Research Group, in a statement. “What’s the purpose of inspecting a facility if you’re not going to take appropriate action when you find conditions that pose a safety threat to patients?”
We asked the FDA for comment and will update you accordingly.
The impetus for the FDA inspections, you may recall, was due to the fungal meningitis outbreak last winter that was traced to the New England Compounding Center. The episode has led so far led to 749 cases, including 61 deaths, and has been described as the worst public health crisis in the US in decades (more here).
The ensuing controversy led to furious debate about the oversight role of the FDA, as well as state health officials, and the extent to which the tragedy could have been prevented. Although FDA officials acknowledged they could have taken enforcement steps sooner against NECC, the agency also lobbied Congress for a new law that would clarify its oversight powers and proposed creating two forms of compounding so that higher-risk production can be more closely regulated (back stories here and here).
STORY ENDS HERE
The contention was made by a consumer watchdog that notes the agency issued an inspection report last March showing that Specialty Compounding, which is based in Dallas, failed to take steps to prevent microbiological contamination, among other problems. But the agency did not issue a safety notice or pressure the company to conduct a voluntary recall.
A product recall did, however, get under way earlier this week, after the FDA after received reports of 15 bacterial infections at two Texas hospitals that were “potentially related” to the company's calcium gluconate infusions. The agency warned that any medicines that were received from the compounder since May 9 should no longer be used, quarantined and returned (read here).
However, in a letter to the Kathleen Sebelius, the secretary of the US Department of Health & Human Services, Public Citizen writes that the FDA could and should have taken action to prevent the infections after its March inspection. And the advocacy group wants Sebelius to order the HHS Office of Inspector General to investigate why the FDA did not press the compounder to conduct a recall sooner.
Moreover, the watchdog wants HHS to press the FDA to review the dozens of other compounding pharmacies that were inspected in recent months and initiate further actions against any pharmacy that was found to have sterility problems similar to those that were seen at Specialty Compounding. Public Citizen notes the FDA has issued inspection reports for 50 facilities, but only 16 have issued a recall or been the subject of an FDA enforcement action.
“The FDA knew there was a serious problem here but didn’t use its existing legal authority to take prompt, aggressive enforcement action against the company. That exposed patients to unnecessary risk and might have contributed to 15 people being infected,” says Michael Carome, who heads Public Citizen Health Research Group, in a statement. “What’s the purpose of inspecting a facility if you’re not going to take appropriate action when you find conditions that pose a safety threat to patients?”
We asked the FDA for comment and will update you accordingly.
The impetus for the FDA inspections, you may recall, was due to the fungal meningitis outbreak last winter that was traced to the New England Compounding Center. The episode has led so far led to 749 cases, including 61 deaths, and has been described as the worst public health crisis in the US in decades (more here).
The ensuing controversy led to furious debate about the oversight role of the FDA, as well as state health officials, and the extent to which the tragedy could have been prevented. Although FDA officials acknowledged they could have taken enforcement steps sooner against NECC, the agency also lobbied Congress for a new law that would clarify its oversight powers and proposed creating two forms of compounding so that higher-risk production can be more closely regulated (back stories here and here).
STORY ENDS HERE
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