What seems like good old common sense scored a victory over drug furor last week when a U.S. District Court ruled that Massachusetts Governor Deval Patrick does not, in fact, outrank the FDA when it comes to deciding which drugs can be sold in Massachusetts.
What's it About?
This squabble was over Zohydro, an opioid pain reliever approved by the FDA in 2013. It is unique in two ways: First, it is the only form of hydrocodone that does not contain acetaminophen, a drug that can cause liver damage when too much is taken. Acetaminophen ("Tylenol") overdose is one of the most common types of poisonings. Second, Zohydro is the only extended-release form of hydrocodone. This is of importance to people who are in constant, around-the-clock pain.
What's The Danger?
Critics point out that because it is an extended-release drug, Zohydro contains more hydrocodone than immediate-release formulations. They claim that this creates a greater danger of abuse if the pills are tampered with to release a large dose at one time. They don't explain what prevents abusers from getting a large dose of hydrocodone by taking several immediate-release tablets. Nevertheless, Zohydro got in trouble. Citing a rise in opioid abuse, Massachusetts Governor Deval Patrick declared a public health emergency and banned the sale of Zohydro in March.
And the Takeaway Is ...
Massachusetts's ban is preempted by federal law. The FDA approves or disapproves drugs, and by banning Zohydro, Massachusetts obstructed the FDA's charge to "promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner."
The district court also looked to the equities and noted that while the ban might prevent some people from abusing the drug, it also would also prevent its legitimate use by all those in need of its unique properties. Zogenix, the makers of Zohydro, sought an injunction against the ban and they won it on constitutional grounds.
- Zogenix, Inc. v. Patrick - Order (FindLaw on Scribd)
- U.S. court reverses Massachusetts ban on Zogenix pain drug (Reuters)
Court Upholds $21.6M Award in Stevens Johnson Syndrome Drug Case (FindLaw's First Circuit Blog)