Lawyers for Zogenix, maker of the controversial drug Zohydro, urged a federal judge today to strike down the state’s restrictions on the drug.
US District Court Judge Rya Zobel had already dismissed the state’s all-out ban on the painkiller in April, saying the state had no authority to ban a drug that had been approved by the US Food and Drug Administration.
The ban targeted any analgesic that has the pain reliever hydrocodone as its sole active ingredient, and that is not tamper-resistant, allowing it to be crushed by abusers and snorted or injected. Zohydro was the only drug that fell within that category.
Governor Deval Patrick’s administration responded to Zobel’s ruling by placing new restrictions on Zohydro, such as requiring doctors to prescribe the drug only when all other drugs had failed, and to certify that the other drugs had failed. Also, only licensed pharmacists — not assistants or technicians — would be able to handle the drug.
Steven P. Hollman, a Zogenix attorney, argued that the tight restrictions would discourage doctors and pharmacists from wanting to use the drug – which would have the effect of banning it. He said officials have publicly acknowledged they want to restrict access to Zohydro.
“The intent is to make the drug less available and deter people from going on the drug,” he argued. He said Zohydro was an effective extended-release painkiller that is safer than other hydrocodone drugs because they contain acetaminophen, which can cause liver failure if taken over long periods of time.
He said the state’s restrictions were “an obstacle to the FDA’s standards and objectives to approve Zohydro.”
The drug has been mired in controversy since it was approved by the FDA in October. As the region and nation face a growing opiod addiction epidemic, critics of Zohydro have said it is too dangerous to put on the market. It contains five times the hydrocodone levels of other drugs, and it is not made in tamper-resistant form.
Jo Ann Shotwell Kaplan, an assistant state attorney general, said the state was clearly targeting Zohydro, but she said doctors have also agreed – and signed affidavits to that effect – that they would still prescribe Zohydro if necessary. She said that concerns that the restrictions would result in the drug being effectively banned were merely speculative.
“We want it only to be available when it’s really needed, and when it is not going to get in the wrong hands,” she said. “Zohydro does pose specialized risks.”
Zobel said she would take the company’s request under advisement.