By Karla L. Palmer & Larry K. Houck –
Representative Edward Markey (D-MA) sent a written request to the U.S. Department of Justice on October 15th asking Attorney General Eric Holder to commence an investigation into whether the New England Compounding Center (“NECC”) violated the federal Controlled Substances Act and its implementing regulations. The letter states that NECC shipped nearly 18,000 vials of contaminated steroid products to 76 healthcare facilities in 24 states; an estimated 14,000 patients have been injected with the tainted products, which have sickened at least 214 individuals and resulted in 15 deaths. The letter notes that almost 1,000 specific formulations of recalled NECC drug products contain controlled substances such as cocaine, morphine, hydromorphone, meperidine, sufentanil, fentanyl and ketamine. (All of these substances are schedule II substances except for ketamine, which is a schedule III substance).
The letter further states that Drug Enforcement Administration (“DEA”) regulations require that “retail pharmacies that compound or sell controlled substances” must be registered with the DEA as retail pharmacies. DEA-registered compounding pharmacies can only sell directly to patients (specifically, the “end user” of the product) compounded pharmaceuticals that contain controlled substances pursuant to a patient-specific prescription from a DEA-registered practitioner. If the pharmacy compounds controlled substances and distributes the formulations to other DEA registrants, it must also be registered with DEA as a manufacturer. Citing to a letter from John Partridge, then-Chief of DEA’s Liaison and Policy Section, dated June 19, 2012, yet not citing to any statute, regulation or DEA guidance document (likely because there is none), Congressman Markey reiterates DEA’s “position” that “compounding a controlled substance other than pursuant to a valid patient-specific prescription or medical order, is manufacturing.” According to a conversation between Markey’s congressional staff and DEA on October 16, 2012, DEA stated that NECC is not registered with DEA as a manufacturer. (Manufacturing, in addition to requiring DEA registration as a manufacturer, also subjects the manufacturer to DEA quota, ARCOS reporting, labeling/packaging and DEA-222 official order form requirements.)
Representative Markey asserts that NECC requires “further investigation” by DEA to determine whether NECC, “already believed to have broken Massachusetts state law, has not also skirted federal law related to controlled substances.” The letter specifically asks the Justice Department to provide answers to the following questions and requests for information:
- As a retail pharmacy, what types of controlled substances NECC was authorized to use to compound under DEA regulations?
- Whether DEA has issued guidance for compounding pharmacies in handling controlled substances. If so, provide copies of such guidance.
- For each drug on both NECC’s recall list and DEA’s list of controlled substances , whether NECC sold each substance (or compounded drug) in compliance with DEA regulations.
- For each of the past ten years, a) how many DEA enforcement actions were brought against pharmacies that failed to comply with DEA regulations, and b) for each violation, the name and location of the pharmacy, the identity of the regulation that was violated and the resolution of that action (i.e., registration suspended, fines levied, warning letter, etc.).
- A description of enforcement actions that DEA could take against a pharmacy that violates the DEA’s controlled substance regulations (including maximum fines, penalties, or other actions).
- Whether the Department of Justice 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 Department put forth to strengthen its “capabilities to perform its duties” in this area.
The letter requests a response to all of the above questions by no later than November 2, 2012. Controlled substance compounders (both manufacturers and pharmacies) across the nation await the DOJ’s and DEA’s responses to Congressman Markey’s requests for information concerning what, in most respects, has been a relatively unregulated area of the pharmaceutical industry.