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Ruling on Massachusetts Ban on Painkiller Pending

Tue, 04/15/2014 - 8:10am
PHILIP MARCELO, Associated Press

BOSTON (AP) — Massachusetts' ban of a powerful new painkiller, Zohydro, remains in effect for now.

U.S. District Court Judge Rya Zobel heard more arguments Monday in a lawsuit that claims the state is overstepping its authority in restricting drug use within Massachusetts in violation of the U.S. Constitution.

The judge declined to immediately rule on a request for a temporary stay of the ban. She did not say when she would make a decision.

The ban, issued in March, is believed to be the first attempt by a state to block a federally-approved drug, according to the National Alliance for Model State Drug Laws. Zohydro is a narcotic, especially helpful in treating pain in patients who can't take acetaminophen.

San Diego-based drugmaker Zogenix asked for the temporary stay while the company seeks an order to lift the ban permanently.

Gov. Deval Patrick has declared a public health emergency in light of widespread prescription drug abuse in the state, but has said he would lift the ban on Zohydro if the drugmaker would develop a more abuse-resistant form.

The state argues that Zohydro will "exacerbate a severe public health crisis" because the drug can be easily crushed, then snorted or injected to create an immediate and potentially lethal high.

Zogenix argued Monday that the medication has already been approved by the U.S. Food and Drug Administration. Stephen Hollman, an attorney for Zogenix, suggested that giving statewide latitude to regulate prescription drugs would erode federal authority.

"Congress intended FDA approvals to have nationwide effect," Hollman said. "Imagine 50 states each imposing a different formulation requirement ... That's the too-many-cooks situation."

He argued that the U.S. Supreme Court has ruled that the FDA establishes a national "floor" for drug regulation. States can impose additional safety restrictions, such as better warning labels, but cannot "eviscerate the floor established by FDA approval."

Assistant State Attorney General Jo Ann Shotwell Kaplan countered that the Massachusetts ban does not affect the federal approval process or the company's ability to sell the drug elsewhere in the United States. She said the ban simply represents "another hurdle" the company must surpass in order to market the drug in Massachusetts.

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