Congressman Edward Markey (D-Mass.) sent a letter to U.S. Attorney General Eric Holder asking the Department of Justice (DOJ) to investigate whether the New England Compounding Company (NECC), allegedly responsible for the deadly fungal meningitis caused by contaminated spinal injections, has violated laws and regulations relating to the sale of controlled substances.
On October 6, 2012, the FDA announced a voluntary recall by NECC of all products compounded at and distributed from its facility in Framingham, Massachusetts. On October 15, 2012, the FDA further advised healthcare providers to follow-up with patients who were administered any NECC injectable product on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC.
The list of recalled NECC drug products includes nearly 1,000 formulations, containing controlled substances such as cocaine, morphine, hydromorphone, meperidine, sufentanil, fentanyl, and ketamine. According to Rep. Markey, reports have indicated that NECC may not have been in compliance withMassachusettslaw because it was selling drugs to pain facilities and hospitals without requiring individual patient prescriptions. Markey’s investigation also indicates that NECC is not registered with the Drug Enforcement Agency (DEA) as a manufacturer of controlled substances.
Markey has also asked the DOJ to provide him with the following information:
- As a retail pharmacy, what types of controlled substances NECC was authorized to use to compound under DEA regulations?
- Whether the DEA has issued guidance for compounding pharmacies in handling controlled substances.
- For each drug on both the NECC’s recall list and the DEA’s list of controlled substances, whether the NECC sold each substance in compliance with DEA regulations.
- For each of the past ten years, how many DEA enforcement actions were brought against pharmacies that failed to comply with DEA regulations, and for each violation, the name and location of the pharmacy, the identity of the regulation that was violated and the resolution of that action.
- A description of enforcement actions that the DEA could take against a pharmacy that violates the DEA’s controlled substance regulations.
- Whether the DOJ believes that it “has sufficient statutory authority and resources to perform its oversight and enforcement responsibilities with respect to compounding pharmacies” and if not, what recommendations can the DOJ put forth to strengthen its “capabilities to perform its duties” in this area.