(Photo: Aaron Couture)
A Boston federal judge on Tuesday struck down a Massachusetts ban on the painkiller Zohydro ER because the U.S. Food and Drug Administration’s approval of the drug trumped the state’s authority.
U.S. District Judge Rya Zobel granted Zogenix Inc.’s preliminary injunction against enforcement of the ban. Zobel’s order takes effect on April 22.
“The FDA has the authority to approve for sale to the public a range of safe and effective prescription drugs—here, opioid analgesics. If the commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health,” Zobel wrote.
She rejected assistant attorney general Jo Ann Shotwell Kaplan’s arguments that FDA regulation is a floor, not a ceiling. Zobel distinguished a 2009 U.S. Supreme Court ruling in Wyeth v. Levine, a drug labeling case the state relied on in arguments and court filing. The Wyeth court held that states can impose regulations on top of FDA requirements.
Furthermore, Zobel wrote in Wyeth the drug at issue would continue to be sold once it complied with the state’s labeling rules. In contrast, Zogenix would be required to return to the FDA and seek approval for a different formulation of its drug.
Zobel concluded that an injunction would be in the public interest. “Although the ban may prevent someone from misusing the drug, the ban prevents all in need of its special attributes from receiving the pain relief Zohydro ER offers,” she wrote.
Concerns about opioid abuse promoted the state’s ban of the drug, which the FDA approved over the its advisory committee’s advice.
Zohydro ER is a time-release drug designed to work over 12 hours. Critics fault it for lacking a tamper-resistant mechanism that would make it difficult to prevent someone to crush it so that the full dose of hydrocodone can be injected or inhaled at once.
The company claims the drug is important for some pain patients because it lacks acetaminophen, which can cause liver damage.
On March 27, Massachusetts Gov. Deval Patrick issued an emergency declaration that enabled Department of Public Health Commissioner Cheryl Bartlett to stop distribution of the drug. Bartlett’s order, also dated March 27, barred the prescription and dispensing of the drug until the San Diego-based Zogenix could set up adequate safeguards against misuse and overdose.
Zobel held a temporary restraining order hearing on April 8 and a preliminary injunction hearing on April 14.
Steven Hollman, a Washington partner at Hogan Lovells who argued for the company at both hearings, said he and his client are gratified that Zobel understood the important constitutional issues and vindicated the FDA’s approval of the drug.
“I think the order also appropriately adjusts the delicate balance between federal and state powers when it comes to regulating prescription medications,” Hollman said.
The Massachusetts Attorney General’s Office, which argued for the state, referred questions to the governor’s office and the health department.
In a statement e-mailed through a spokesman, Patrick stated that he was “disappointed by the court’s decision because it places commercial interests above the public’s health. Addiction is a serious enough problem already in Massachusetts without having to deal with another addictive narcotic painkiller sold in a form that isn’t tamper proof.”
Sheri Qualters can be contacted at firstname.lastname@example.org.