State argues ban on painkiller Zohydro should stand
Arguing that harm to the public interest outweighs harm to a single company, the state laid out its case to a federal judge on Monday as to why she should allow the temporary ban on the controversial painkiller Zohydro to stand.
Despite saying last week that she would make a ruling on Monday, Judge Rya Zobel took the arguments from the state and the drug maker under advisement and did not issue a decision by press time, meaning the state’s ban remained in effect. The federal court hearing was attended by a half dozen mothers of drug addicts from the group Learn to Cope who also confronted the company’s president after the proceeding.
The drug’s maker, Zogenix, filed a motion in federal court last week seeking an injunction to the state’s ban that came after Gov. Deval Patrick last month declared a public health emergency because of an “epidemic of opiate abuse.”
The company said Zohydro tackles severe pain in patients requiring continuous around-the-clock opioid therapy. It was approved by the Food and Drug Administration in October, despite an 11-2 vote by the agency’s advisory panel not to do so.
Steven Hollman, a lawyer for Zogenix, argued that the state’s ban causes irreparable harm to the company and was done “without regard” to the impact on pain patients. He also argued that the ban goes against the purpose of the federal agency.
“Imagine 50 states each imposing a different formulation requirement,” he said. “There is not room for states to impose restrictions that eviscerates the floor of FDA approval.”
Zobel asked Assistant Attorney General Jo Ann Shotwell Kaplan if she found any other case where a state sought to restrict a drug approved by the FDA. Shotwell Kaplan said she hadn’t.
“You are seeing this case that has not been brought before,” she said. Shotwell Kaplan said the situation is “quite unusual,” citing the number of states that have spoken out against the painkiller, the FDA approving it against its advisory board’s vote and in the middle of a declared public health emergency.
“If there were ever a case where states would be prepared to do this, I think this is it,” she said.
In declaring the public health emergency, state officials enacted the immediate prohibition of the prescribing and dispensing of any hydrocodone-only formulation until adequate measures are in place to safeguard against potential overdose and misuse.
The state Department of Public Health recently released data that show 668 Massachusetts residents died in 2012 from unintentional opioid overdoses, up 10 percent from the year before. State police have said that about 140 people have died from suspected heroin overdoses between November and February, but that number does not include Boston, Worcester and Springfield.
Attending Monday’s court hearing was a group of about a half dozen mothers of drug addicts from the support group Learn to Cope. The group, some wearing T-shirts with their group’s name, sat in the front row and listened to the arguments.
“Already so many people are dying from this [epidemic],” said group member Angela Whitney. “We have so many addicts out there. It’s the boy who mows your lawn. It’s the cheerleader. It’s heartbreaking.”
After the hearing some of the group members confronted Zogenix President Stephen Farr. They told them about the group and asked him to attend one of their support meetings. They also questioned the safety of the company’s painkiller.
“We embrace ensuring that all our products are as safe as they can possibly be,” Farr told them.
Follow Michael Naughton on Twitter @metrobosmike.