Federal agents have raided a Massachusetts compounding pharmacy linked to a deadly meningitis outbreak that has killed 15 people and sickened hundreds of pain patients across the country.
“I can confirm that this office and our law enforcement partners are investigating allegations concerning the New England Compounding Center,” U.S. Attorney Carmen Ortiz said in a statement.
Agents with the Food and Drug Administration, with the assistance of local police, searched the NECC facility in Framingham. Ortiz said it was “premature” to say what the investigation was about.
The raid came the same day Massachusetts Rep. Edward Markey sent a letter to Attorney General Eric Holder asking if NECC violated federal law by producing and distributing narcotic medications that contain controlled substances.
“The list of recalled NECC drug products appears to include nearly 1,000 specific formulations that contain controlled substances that fall under the purview of the Drug Enforcement Agency (DEA) including substances such as cocaine, morphine, hydromorphone, meperidine, sufentanil, fentanyl, and ketamine,” Markey said.
According to federal regulations, compounding pharmacies that sell controlled substances must be registered with the DEA and are only permitted to provide the drugs to patients who have prescriptions. NECC is under investigation by Massachusetts regulators for providing drugs to pain clinics without requiring individual patient prescriptions.
“This is a matter that I believe requires further investigation by the DEA to ensure that this facility, already believed to have broken Massachusetts state law, has not also skirted federal law related to controlled substances,” Markey said.
NECC issued a voluntary recall of all of its products last week, asking all clinics, hospitals and health care providers to stop using them immediately.
As many as 14,000 people have received injections of methylprednisolone acetate, a contaminated steroid produced by NECC that was primarily used in epidural injections to relieve back pain. The company sold the steroid to 75 pain clinics in 23 states.
The Centers for Disease Control and Prevention reported Tuesday that the meningtiis outbreak has sickened 231 people with fungal meningitis and two more patients with peripheral joint infections.
The FDA says one case of “possible” meningitis is associated with a second type of steroid made by NECC that was administered during an epidural. Another patient who received an NECC heart drug during transplant surgery also developed a fungal infection. The FDA says there could be other explanations for the infections.