The Food and Drug Administration has certainly heard the criticism of Zohydro, a powerful new painkiller approved last October.
Regulators heard it first from the FDA’s own advisory board, which recommended against the approval of the drug being compared to OxyContin in its strength and potential for abuse.
They then heard it from the attorneys general of 28 states, including Maine, who last December asked that Zohydro at least be made tamper-proof, so that it can’t be crushed, then snorted or injected, for a better high.
And last week, they heard it from governors in Vermont and Massachusetts, who both have taken steps to keep Zohydro from being prescribed, and from at least three New England hospitals that will not stock the drug.
Yet still the FDA has done nothing.
Maine should make its voice heard in this latest chorus, and help push the federal agency into action. It is just a small front in the fight against opiate abuse, but without the proper safeguards Zohydro will end up exacerbating an already dire problem.
There are a few paths Maine could take.
In Massachusetts, Gov. Deval Patrick last week issued an executive order prohibiting the sale of Zohydro, as part of his declaration of a public health emergency surrounding the growing abuse of opiates.
The maker of Zohydro, Zogenix, however, filed suit Monday, asking the U.S. District Court in Massachusetts to set aside Patrick’s order, arguing that it “impedes the FDA’s congressional mandate” to set drug policy.
Vermont Gov. Peter Shumlin, fearing litigation, did not go quite as far.
Shumlin, who used his state of the state speech earlier this year to argue for a strong, treatment-based response to the opiate addiction epidemic there, has issued an emergency order making it more difficult to prescribe Zohydro.
The order, announced April 3, requires prescribers to conduct a thorough medical evaluation and risk assessment, and to show that no other type of painkiller would work for the patient.
Shumlin also has some major health care providers on his side.
Fletcher Allen Health Care, Vermont’s largest provider, will not stock Zohydro, nor will Rutland Regional Medical Center, in Rutland, Vt., and Dartmouth-Hitchcock Medical Center, in Lebanon, N.H.
Gov. Paul LePage should follow Shumlin’s lead and put restrictions on Zohydro here in Maine. At the same time, hospitals and physicians should not prescribe the medication.
That will push the FDA to act, and Zogenix to incorporate into Zohydro abuse deterrents, such as a gel that makes it difficult to crush.
Lessening the prescription drug problem will take a strong drug monitoring system, which Maine has, and treatment, which has lagged in the last few years because of cuts in funding.
Blocking Zohydro, however, also will help, by keeping it from reaching the streets, and by forcing manufacturers to make better drugs, and better ways to curb abuse.