WASHINGTON House Republicans claimed on Tuesday that the Food and Drug Administration should taken action much earlier on the Massachusetts pharmacy responsible for making contaminated medications that lead to a deadly meningitis outbreak.
A report issued by Republicans states that the FDA failed to act on years of complaints about problematic drugs and practices at the New England Compounding Center (NECC).
The pharmacy produced tainted preservative-free methylprednisolone acetate injections which were used to manage pain. They sickened more than 700 Americans, killing 53 others. Illnesses include fungal meningitis, abscesses and secondary fungal infections in some patients who had already been diagnosed with meningitis.
Compounding pharmacies mix customized prescriptions based on a single doctor's instructions, but it seems that some companies like NECC were operating in bulk.
In their second hearing on the issue, Republicans on a House subcommittee blasted the FDA for suspending inspections of the NECC and other compounding pharmacies in 2011. Agency lawyers recommended the halt in enforcement due to legal questions about government authority to police compounding pharmacies.
The FDA's commissioner told lawmakers she was unaware of that decision at the time.
Earlier in April 2013, the FDA announced that they found safety and sterility problems at 30 other compounding pharmacies which mixed sterile prescriptions for patients. Issues included unsanitary conditions, quality control problems, rust and mold in sterile rooms, inadequate ventilation and employees wearing non-sterile lab coats. The inspections were in response to the NECC case.