Federal Judge Blocks Massachusetts’ Restriction on Prescribing Zohydro

July 15, 2014

A federal judge struck down Massachusetts’ recently enacted prescribing restrictions on Zogenix’s opioid painkiller Zohydro ER — restrictions that the drugmaker argued had effectively made the therapy unavailable and contravened the FDA’s right to approve drugs it considers safe and effective.

The July 8 ruling by Judge Rya Zobel of the District Court for the District of Massachusetts blocked an April 22 emergency regulation by the state’s Board of Registration in Medicine that required physicians prescribing Zohydro to provide a letter of medical necessity (LMN) to the state explaining patients’ diagnoses and treatment plans. That regulation also required physicians to verify the failure of other available treatments, and attest that they performed a risk assessment plan, as well as enter into a pain management treatment agreement with the patient.

The LMN requirement is ambiguous, Zobel wrote, because it does not adequately define the parameters and time period required to prove that other pain treatments had failed. At worst, she said, it might potentially require a physician to “cycle a patient through unnecessary and possibly dangerous pain management alternatives before prescribing Zohydro.”

Zogenix praised the ruling, saying “the court’s decision supports the importance of upholding the principle at the heart of this case, which is that the FDA is the only regulatory body that is authorized to determine the approval and access of medicines for all Americans.”

The drugmaker, however, did not win its request to stop a May 6 regulation from the state’s Board of Regulation in Pharmacy that prohibited “a certified pharmacy technician, pharmacy technician, pharmacy technician trainee, or pharmacy intern” from handling Zohydro. This would limit dispensing of the drug only to pharmacists, Zogenix claimed, making it impractical and effectively impossible for pharmacies to provide patients with the drug.

The judge said that because Zogenix did not provide specific examples of pharmacies that were declining to carry Zohydro in the wake of this regulation, it had not met its burden of proof.

The FDA approved Zohydro last fall. Massachusetts attempted to ban the drug in March, claiming that it had a high risk of abuse, but Judge Zobel overturned the ban, claiming that Massachusetts was preventing the FDA from doing its job. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.