Judge set to rule on drug firm's suit against Massachusetts for painkiller ban
Can a state ban a drug that has the federal government's seal of approval?
The answer could arrive as soon as Monday in a Massachusetts courtroom, where a federal judge is expected to rule on Gov. Deval Patrick's recent decision to prohibit the sale of a powerful new painkiller approved last fall by the Food and Drug Administration.
Last month, citing a “public health emergency” prompted by rising deaths because of drug addiction, Patrick, a Democrat, barred Zohydro, a controversial prescription drug consisting of a pure dose of hydrocodone, the main ingredient in the painkiller Vicodin. Critics say that the drug, which hit the market in March, invites abuse because of its potent formula and lack of tamper-resistant features.
Patrick's move is an aggressive, if novel, effort to slow the toll caused by widespread abuse of opioids, which include prescription medications such as OxyContin and illegal substances such as heroin. Prescription-drug overdoses have risen steadily during the past decade and account for an estimated 16,000 deaths a year in the United States.
The FDA has been hit with a backlash since approving Zohydro over the objections of an outside advisory panel, which voted 11 to 2 to recommend rejection of the drug. Lawmakers from both parties have urged the Obama administration to reconsider the FDA decision. Dozens of state attorneys general have warned that the drug could undermine years of work in fighting the nation's prescription-drug epidemic.
Vermont Gov. Peter Shumlin, a Democrat, this month issued an emergency order intended to make it harder for doctors to prescribe Zohydro. Some hospitals have refused to stock the drug. But no place has taken more drastic measures than Massachusetts.
“To our knowledge, this is the first time it's ever happened, that a state has banned an FDA-approved drug,” said Heather Gray, a legislative attorney for the nonprofit National Alliance for Model State Drug Laws.
Gray cited the legalization of marijuana in Colorado and Washington as instances in which states have permitted substances that remain illegal on the federal level. But rarely, if ever, has a state forbidden the sale of a medication approved by federal regulators.
“If states start taking it into their own hands, deciding what to allow or not allow citizens in their own states to take, that could cause problems,” Gray said. “What if you have another governor who says, ‘I'm Catholic, and I don't like contraception, so I'm not going to allow physicians in my state to prescribe contraceptives'? I don't think it will get to that point, but that's an example of what potentially could happen.”