Last night, in a scene reminiscent of a covert drug bust, FDA agents raided the Boston-area pharmacy tied to the deadly Meningitis outbreak. The raid coincided with a wider probe into whether the facility where the drugs are manufactured, the New England Compounding Center, violated federal laws covering potentially addictive drugs.
Reuters with more:
The outbreak has raised questions about how the pharmaceuticals industry operates. NECC engaged in a practice called drug compounding that is not regulated by the FDA, which generally oversees drug manufacturers. In compounding, pharmacies prepare specific doses of approved medications, based on guidance from a doctor, to meet an individual patient’s need.
A Reuters investigation found that NECC solicited bulk orders from physicians and failed to require proof of individual patient prescriptions as required under state regulations, emails to a customer showed. State pharmacy regulators have said that NECC violated its license in Massachusetts by not requiring patient prescriptions before shipping products.
A lawyer for drug maker said the raid was unnecessary and that “asking would have produced the same result.” The raid came in the wake of a mounting death toll linked to steroid injections contaminated with meningitis that were manufactured at the NECC facility. So far the outbreak has killed 16 people and sickened more than 200 others in 15 states and counting.
Meningitis is an infection of the membranes covering the brain and spinal cord. Symptoms include headache, fever and nausea, but the disease is not contagious.