United States District Court, D. Massachusetts
DEVAL PATRICK, in his official capacity as GOVERNOR OF MASSACHUSETTS, et al.
MEMORANDUM OF DECISION
RYA W. ZOBEL, District Judge.
The issue is whether two Massachusetts regulations limiting the prescribing and handling of ZohydroTM ER ("Zohydro"), a Food and Drug Administration-approved opioid analgesic, frustrate federal statutory objectives in violation of the Supremacy Clause of the United States Constitution. Plaintiff Zogenix, Inc., believes they do and moves for a preliminary injunction barring their enforcement (Docket # 46). Defendants, Commonwealth health officials sued in their official capacities, believe they do not and move to dismiss (Docket # 44). Plaintiff's motion is ALLOWED IN PART and DENIED IN PART. Defendants' motion is DENIED.
On October 25, 2013, the Food and Drug Administration ("FDA") approved Zohydro, the only opioid analgesic whose sole active ingredient is hydrocodone. Unlike other hydrocodone analgesics, Zohydro does not contain acetaminophen, which may cause liver damage. As an "extended release" medication, Zohydro dispenses pain relief over a twelve-hour period. The drug, however, lacks an "abuse resistant formulation, " permitting individuals to crush the pills, inhale or inject them, and immediately experience the full effect. Some Massachusetts officials worried that Zohydro could cause or worsen opioid abuse in the Commonwealth.
Governor Patrick authorized, and the Department of Public Health ("DPH") issued, an emergency order which banned the prescribing, ordering, dispensing, or administration of Zohydro. Plaintiff sued and sought a preliminary injunction on the ground that federal law preempted the emergency order. I agreed, and on April 15, 2014, enjoined enforcement of DPH's emergency order. I stayed the preliminary injunction until April 22, 2014.
On that day, the Board of Registration in Medicine ("BORIM") promulgated an emergency regulation requiring an individually licensed prescriber to do the following before prescribing Zohydro:
(a) Thoroughly assess the patient, including an evaluation of the patient's risk factors, substance abuse history, presenting conditions(s), current medication(s), and a check of the online Prescription Monitoring Program;
(b) Discuss the risks and benefits of the medication with the patient;
(c) Enter into a Pain Management Treatment Agreement with the patient that shall appropriately address drug screening, pill counts, safe storage and disposal and other requirements based on the patient's diagnoses, treatment plan, and risk assessment;
(d) Supply a Letter of Medical Necessity as required by the Board of Registration in Pharmacy that includes the patient's diagnoses and treatment plan, verifies that other pain management treatments have failed, indicates that a risk assessment was performed and that the licensee and the patient have entered into a Pain Management Treatment Agreement; and
(e) Document 243 CMR 2.07(25)(a)-(d) in the patient's medical record.
243 CMR 2.07(25) (emphasis added).
On May 6, 2014, the Board of Registration in Pharmacy ("BORIP") promulgated two Zohydro-related regulations. The first states that "[a] certified pharmacy technician, pharmacy technician, pharmacy technician trainee, or pharmacy intern may not handle [Zohydro]." 247 CMR 8.05(3). The second contains a host of prerequisites a pharmacist must satisfy before dispensing Zohydro, including: (1) storing Zohydro in a locked cabinet; (2) dispensing Zohydro in a container with a child-proof safety cap; (3) reviewing the Letter of Medical Necessity; (4) including a warning about Zohydro's dangers; (5) providing counseling on various issues; and (6) checking the patient's history on the Prescription Monitoring Program. Id . 9.04(8).
On May 8, 2014, the Board of Registration of Physicians Assistants ("BOROPA") promulgated a set of regulations identical to the ...