|Massachusetts Gov. Deval Patrick|
While congressional reps and activists flog the FDA for approving the powerful new painkiller Zohydro, Massachusetts Gov. Deval Patrick is taking a more direct approach. Patrick says he's banning Zohydro from his state until Zogenix ($ZGNX) develops an abuse-deterrent version.
Zohydro, the only pure hydrocodone pain pill on the market, "poses a significant risk" to the public, the governor's office said in a release. The state will "[i]mmediately prohibit the prescribing and dispensing of any hydrocodone-only formulation (commonly known as Zohydro) until … adequate measures are in place to safeguard against the potential for diversion, overdose and misuse."
It's just the latest in a fast-moving controversy over Zohydro's success at the FDA. The brouhaha began even before the drug was approved, and the agency's own expert panel voted overwhelmingly against allowing Zohydro onto the market. The FDA approved the drug anyway last December, and protests immediately began. State attorneys general urged the FDA to reconsider. Congress called a hearing, and West Virginia Sen. Joe Manchin introduced a bill that would force the agency to pull the drug.
Zogenix is none too happy about Patrick's action. The ban "only serves to unfairly restrict patient access," the company said in a statement. Zogenix plans to explain "the safe use measures already in place" to Massachusetts officials. Zohydro was approved under a risk-management plan designed to limit access to the drug, to keep it out of the wrong hands.
Agency officials have defended Zohydro, saying it's an important option for patients in terrible pain. Meanwhile, OxyContin maker Purdue Pharma says it's developing a tamper-resistant version of hydrocodone, a move that could squash Zogenix's version. The FDA could actually yank Zohydro's approval if Purdue's efforts succeed. But that's just a maybe; in a congressional hearing about Zohydro last month, FDA Commissioner Margaret Hamburg said abuse-deterrent pill technology is "poor."
"Once/if the Purdue product is approved, possibly in 2015, FDA could then rule that Zohydro is not as safe as the abuse-deterrent product and either pull the drug's approval or ask Zogenix to withdraw it voluntarily," Capital Alpha Partners analyst Rob Smith told Reuters.
Whether Patrick can make his ban stick is an open question. After all, the FDA is a federal agency, and its approval of Zohydro could pre-empt state-level action. But FDA pre-emption of state law is a tricky subject; in product-liability cases, pre-emption arguments have tended to fall flat.
The Zohydro ban is part of a painkiller-addiction "state of emergency" that Patrick declared Friday. The governor also announced $20 million in spending on addiction treatment and recovery services, and better access to an overdose-treatment drug. Under Patrick's declaration, state regulators can go ahead and implement new rules, and then urge the legislature to make the changes permanent, the Boston Globe reports.
Special Report: The FDA's new drug approvals of 2013