ZOHYDRO Daily News Updates

April 8, 2014 Updates

Federal judge: Gov. Deval Patrick “is out of line” in banning opioid drug Zohydro
Shira Schoenberg

BOSTON — Gov. Deval Patrick’s ban on the opioid drug Zohydro will remain in effect until another court hearing on Monday morning, a judge ruled Tuesday.

But U.S. District Court Judge Rya Zobel indicated that she is skeptical of Patrick’s authority to ban a drug that the U.S. Food and Drug Administration has declared safe.

“At the moment, I think that, frankly, the governor is out of line on this,” Zobel said.

Zohydro is made of the opioid hydrocodone and is used for treating severe chronic pain. On March 27, Patrick issued an order to immediately ban the prescribing and dispensing of Zohydro in Massachusetts until it can be determined that “adequate measures are in place to safeguard against the potential for diversion, overdose and misuse.” The step was one of several actions Patrick took when he declared a public health emergency to address an opioid addiction epidemic.

As a drug, Zohydro is unique because it includes only hydrocodone and is not mixed with other drugs such as acetaminophen. Zogenix argues that this makes it a better drug for patients who have problems with acetaminophen, which can cause liver damage in high doses. But Patrick’s administration and other opponents of the drug say the high dose of hydrocodone also makes it more susceptible to abuse. The drug was approved by the FDA in October 2013, despite the advice of an independent FDA advisory board, which recommended against the approval.

The drug is new to Massachusetts. Only four prescriptions have been written and none have been filled so far, according to Zogenix’s attorneys.

Zogenix, the maker of Zohydro, sued Patrick and Department of Public Health Commissioner Cheryl Bartlett, asking for an injunction to overturn the ban.

Zogenix argues that the FDA already considered – and rejected – the idea of requiring the company to use abuse-deterrent technology. Attorney Steven Hollman, who represents Zogenix, said Zogenix went through a lengthy approval process with the FDA and complied with all the required clinical trials and safety standards.

“Certainly, there are those in the scientific community who are concerned about opioid abuse in general, but they’re concerned about the class of opioid abuse, not concerned about singling out this particular drug, which has been determined by the FDA to be as safe and effective as any other hydrocodone opioid that’s already on the market,” Hollman said.

The ban, Hollman said, puts the governor and the commissioner “in direct conflict with the determination made by the science and medical regulatory experts at the FDA that Zohydro Extended Relief is in fact safe and effective for its intended use.”

Assistant Attorney General Jo Ann Shotwell Kaplan, who represents Patrick and Bartlett, argued that the FDA’s approval does not mean Massachusetts cannot go further in restricting the drug.

“They do not cite a single case that stands for the proposition that the FDA approval of a drug entering the national marketplace is anything other than a floor, a threshold determination that allows it to be in the marketplace generally, that does not preclude the exercise of state police powers in order to propose stricter regulations,” Shotwell Kaplan said.

“There was and is a severe public health emergency that caused the governor to react as he did there,” Shotwell Kaplan said. “We have unprecedented numbers of people dying from heroin overdoses and other opiate overdoses…To add to this marketplace at this time a drug that’s especially, unusually, more than any other drug capable of this kind of abuse and fatality is a public health issue.”

Shotwell Kaplan, however, said she was not prepared to argue the merits of the case on Tuesday, since she only received notice of the case and the motions that morning, and had not had time to fully read the material, much less research a response.

Zobel continued the hearing until Monday to give Shotwell Kaplan a chance to respond. But the judge indicated that she was unhappy with the fact that the Patrick administration had not talked to Zogenix before banning the drug.

“You got five hours notice. They got no notice at all,” Zobel said.

Judge indicates she’ll strike down Zohydro ban
The Boston Globe
Milton J. Valencia
April 8 ,2014
A federal judge indicated today that she will likely strike down Governor Deval Patrick’s ban on the controversial prescription painkiller Zohydro, noting that the drug has been approved by the US Food and Drug Administration.

US District Court Judge Rya W. Zobel would not grant an immediate restraining order as requested by drugmaker Zogenix, but scheduled a followup hearing for Monday, saying it appeared that Zogenix would have a likelihood of winning the case.

“I think, frankly, the governor is out of line on this,” Zobel said.

She urged both sides to discuss the issue before Monday.

“I do not expect this to be a very long hearing,” she said.

Patrick declared a public health emergency in late March to combat the growing opiate abuse problem.

He announced a number of measures intended to combat the problem, including a ban on Zohydro, calling it a “potentially lethal narcotic painkiller.”

Patrick said the drug, which is not yet made in tamper-proof form, would be banned until safeguards were in place. Drug treatment providers have warned of Zohydro’s high potential for abuse

But last year, in a controversial decision by the Food and Drug Administration, the drug was approved.

Painkiller ban raises constitutional questions
The Associated Press
April 8, 2014

BOSTON (AP) — A federal judge says Massachusetts Gov. Deval Patrick might have been “out of line” in ordering a first-in-the-nation ban of Zohydro, a powerful new painkiller.

U.S. District Court Judge Rya Zobel on Tuesday considered a request by Zogenix, the San Diego-based maker of the drug, to immediately and temporarily halt enforcement of the state-level ban. The company says the ban is unconstitutional.

After hearing briefly from both sides, Zobel said she would hear more detailed arguments Monday, after which she expects to render a decision on a temporary stay. The judge said she would decide at a later date whether or not the ban should be permanently vacated.

Zohydro has been approved by the U.S. Food and Drug Administration but some health authorities say the drug can be easily abused.

Zogenix sues Massachusetts over ban on controversial painkiller Zohydro
Arlene Weintraub
April 8, 2014

In late March, Massachusetts Governor Deval Patrick banned the newly approved purely hydrocodone pain pill Zohydro–and now the maker of that drug is fighting back. Zogenix ($ZGNX) filed a lawsuit in a Boston federal court seeking a restraining order against the governor’s Zohydro ban. Zogenix sued after Patrick failed to respond to a request for a meeting to discuss the drug, according to Reuters.

Zohydro, the first pure opiate ever approved by the FDA, does not have abuse-deterrent features that would stop addicts from crushing it to get an immediate high. Patrick said in a release that the pill “poses a significant risk” to the public and that no pharmacy in the state would dispense it until measures were put in place to “safeguard against the potential for diversion, overdose and misuse.”

In its lawsuit, Zogenix criticizes Patrick for taking “unilateral action” to ban Zohydro without giving the company any advance notice, according to Bloomberg. Furthermore, the complaint says, “When FDA approved Zohydro, it considered but rejected the idea of requiring the drug to utilize abuse-deterrent technology.” Zogenix’s shares have fallen 16% to $2.46 since Patrick’s ban, Bloomberg notes.

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The FDA has been under fire ever since it approved Zohydro last October. More than half of the states’ attorneys general asked the agency to withdraw the approval, and the grassroots organization Fed Up! Coalition petitioned FDA Commissioner Margaret Hamburg to reassess the drug in late February. But she told the Senate she wouldn’t back off, and that the long-acting Zohydro is a safe and effective option for patients with excruciating pain.

That’s not to say the FDA isn’t concerned about the opioid epidemic, Hamburg emphasized last week, after the agency approved Evzio, a single dose of naloxone that medics can use to reverse a painkiller overdose. “Tackling the opioid epidemic is a high priority for the FDA,” Hamburg told the press during a briefing on the Evzio approval. The FDA also acknowledged that prescription drug overdoses are now the leading cause of injury-related deaths in the U.S., surpassing car accidents.

Zogenix Sues Massachusetts Over Order Banning ZOHYDRO ER; Alleges Ban is Unconstitutional
FDA Law Blog
Kurt R. Karst
April 8, 2014

Shortly after Massachusetts Governor Deval Patrick issued a press release on March 27, 2014 announcing a Declaration of Emergency and that the Governor had directed the Massachusetts Department of Public Health (“DPH”) and its Commissioner, Cheryl Bartlett, RN, to take several actions to combat opioid overdose, including granting DPH “emergency powers” to, among other things, ban the prescribing and dispensing of ZOHYDRO ER (hydrocodone bitartrate) Extended-release Capsules, rumors began to swirl that the manufacturer of the drug, Zogenix, Inc. (“Zogenix”), would take legal action.  Those rumors intensified when later on March 27, 2014 the DPH Commissioner Bartlett and the Public Health Council approved an Emergency Order stating: “No registered individual practitioner shall prescribe or order, and no one shall dispense or administer any hydrocodone bitartrate product in hydrocodone-only extended-release formulation until the Commissioner has determined that adequate measures are in place to safeguard against the potential for diversion, overdose and abuse.”

Less than two weeks after Governor Patrick’s announcement, and now that other states are considering (or taking) similar action (e.g., Vermont recently issued an emergency rule that will reportedly make it more difficult for physicians to prescribe the drug within state limits), Zogenix is taking a stand.  Earlier this week, Zogenix filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction in the U.S. District Court for the District of Massachusetts alleging that the Commonwealth’s ban on ZOHYDRO ER is unconstitutional because the ban violates the Supremacy Clause, the dormant Commerce Clause, and the federal Contracts Clause of the U.S. Constitution:

To put it in plain terms: the Order banning Zohydro™ ER is unconstitutional.

To begin with, it is preempted by federal law.  FDA, not Governor Patrick and not the State DPH, has the authority to approve new drugs, to determine the formulations that are safe and effective for use, and to authorize their introduction into the interstate market.  And after extensive consideration, FDA approved Zohydro™ ER in its current formulation, finding it safe and effective for use in treating patients with chronic pain for whom their physicians conclude Zohydro™ ER is indicated.  Neither Governor Patrick nor the state DPH has the authority or the ability to countermand that determination and declare Zohydro™ ER unsafe in its current formulation.  The Order also runs afoul of the dormant Commerce Clause, which prohibits a state from taking a regulatory action that has impact outside its borders, or if which replicated would result in the effective dismantlement of a national regulatory scheme.  And it violates the federal Contracts Clause, because the Order undoes private contracts between Zogenix and other contracting parties for services in Massachusetts, all without sufficient justification.

FDA approved ZOHYDRO ER on October 25, 2013 under NDA No. 202880 after an extended review cycle for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.  ZOHYDRO ER is manufactured without an abuse-deterrent formulation, and that fact has made the approval controversial.  Indeed, several members of Congress have sent letters to FDA protesting the approval, and legislation has been introduced to withdraw the NDA approval (S. 2134 and H.R. 4241).  Nevertheless, ZOHYDRO ER remains an approved medication.  And as Zogenix points out in its lawsuit:

In rendering a considered decision that the benefits of Zohydro™ ER outweighed the drug’s potential risks, the FDA satisfied Congress’s dual mandate of promoting and protecting public health by classifying Zohydro™ ER as “safe and effective,” consistent with its obligations under 21 U.S.C. § 393(b)(2)(B).  That determination reflects the FDA’s expert conclusion that public access to the drug “promote[s]” the public health. 21 U.S.C. § 393(b)(1).

Thus, Zogenix argues that the Commonwealth’s ban on ZOHYDRO ER:

Stands as an impermissible obstacle, in two ways, to the FDA’s mandate to make particularized drug approvals for the protection and promotion of the public health.  First, . . . state drug prohibition decisions contrary to those of the FDA – such as the Massachusetts ban here – would harmfully undermine the authoritative character of federal safety decisions designed to have national effect. . . .  Second, the Massachusetts order plainly conflicts with the scientific predicates supporting the FDA’s approval of the same drug Massachusetts wants banned – and thus with Congress’ objective to promote public health by facilitating access to important treatments.

Zogenix is seeking, among other things, declaratory and injunctive relief.  Specifically, Zogenix seeks a declaration that Governor Patrick’s and DPH Commissioner Bartlett’s conduct in effectuating a ban on ZOHYDRO ER violates the U.S. Constitution, and final order enjoining Massachusetts from implementing or enforcing the Declaration of Emergency, the Emergency Order (or any other action banning the prescription, ordering, dispensing, and administration of ZOHYDRO ER), or an order vacating those actions.  A hearing was held on April 8th regarding Zogenix’s Motion for Temporary Restraining Order and Preliminary Injunction.  Judge Rya W. Zobel allowed a continuance to allow the parties some additional time.  A hearing is now scheduled for April 14th at 9:00 AM.

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