The firm at the heart of the deadly meningitis outbreak across the United States violated state regulations, according to e-mails obtained by Reuters. The New England Compounding Center, a drug-mixing company based in Framingham, Mass., reportedly sent drugs without obtaining patient names or prescriptions, and had physicians place bulk orders for the contaminated steroid responsible for the deaths of 14 people.
NECC also referred business to a sister company, Ameridose. Both firms have since suspended their operations and recalled the steroid, which has sickened an additional 184 Americans and put 14,000 people at risk, according to Reuters.
Dr. Madeleine Biondolillo, director of Massachusetts' Bureau of Health Care Safety and Quality, said that NECC should only have made up vials of the drug in response to patient prescriptions.
"This organization chose to apparently violate the licensing regulations under which they were allowed to operate," Biondolillo told reporters in a telephone news conference, ABC News reported.
Compounding drugs has been practiced by pharmacists for years, and is meant to combine and mix unique medicine combinations for individual patients' needs. However, the practice has grown into a business for large firms, according to HealthDay.
“Consumers need to be aware that compounded drugs are not FDA-approved,” said Kathleen Anderson, deputy director of the FDA’s Division of New Drugs and Labeling Compliance in the Center for Drug Evaluation and Research. “This means that FDA has not verified their safety and effectiveness.”
Massachusetts Sen. Scott Brown is also embroiled in the scandal: the politician co-signed a July 24 letter to the Drug Enforcement Administration that argued in favor of “a top legislative priority of the compounding pharmacy industry," just six weeks before he received a $10,000 campaign donation from NECC co-owner Gregory Conigliaro, Forbes reported.
Brown has since donated the $10,000 to the Meningitis Foundation of America and said there is no link between the donation and his letter.