WASHINGTON: US lawmakers slammed federal and state health officials for failing to properly police a pharmacy whose tainted drugs caused a deadly fungal meningitis outbreak.
“This tragedy could have been avoided,” said Congressman Cliff Stearns, who chairs the Energy and Commerce Committee’s oversight and investigations panel.
The Florida Republican cited a litany of complaints against the New England Compounding Centre and problems found during inspections over the past decade that were insufficiently investigated.
One such incident was when the Food and Drug Administration received reports in 2002 that patients receiving NECC steroid injections had experienced “adverse events,” including “meningitis-like” symptoms.
“The product in question was the very same product connected to the current outbreak. In that case, the NECC drug was contaminated with bacteria,” Stearns said.
While the FDA inspected NECC’s Massachusetts facility in response to the complaints, that did not prevent more patients from getting sick from the same drugs six months later.
At a 2003 meeting with Massachusetts health officials – who hold primary responsibility for regulating pharmacies in their state – Stearns said the FDA made a “prophetic statement.”
“The FDA stated that there was the potential for serious public health consequences if NECC’s compounding practices, in particular those relating to sterile products, are not improved,” Stearns said.
Some 461 people have been sickened – and 32 of them have died – after receiving injections of NECC’s tainted steroids, according to the latest tally by the Centers for Disease Control and Prevention.
The outbreak has led to calls for tighter regulation of the loosely controlled pharmaceutical compounding industry.
Federal investigators have launched a criminal probe into the case.
“Even though FDA was clearly aware of the risks posed by NECC’s compounding practices, the agency was slow to act,” Stearns said.
It took the agency four years to issue a warning letter based on problems it found with NECC’s sterility practices in 2002 and two more years for the FDA to respond to the company’s claims challenging the report. -PTI
