Wednesday, April 30, 2014

Zohydro or Pot, A study in Federalism

The debate continues on Zohydro. There has been a significant amount of opposition to the distribution of this opiod. Despite the recomendation against Food and Drug Administration approval, from the FDA's own panel of experts, the FDA approved this strong (allegedly 5 times more powerful than Vicodin) medication last fall. Unlike other opiods on the market, this one comes without all those pesky anti-abuse ingredients and precautions. This one can be easily and readily crushed for ease of abuse. The medication is so strong that it has been referred to as "heroin in a pill."

Massachusetts tried to take action on its concerns about this strong narcotic. The Governor banned its sale by executive action. The maker of Zohydro, Zogenix, filed a complaint and alleged that the Commonwealth's executive order banning the sale of Zohydro is unconstitutional and they sought an injunction. On April 15, 2014, the court granted the injunction and precuded enforcement of the state's ban. The court concluded that the FDA action approving the drug preempted the Commonwealth's ban. 

Zogenix successfully argued that the Supremacy Clause of the Constitution compelled the conclusion that anything in "state law that conflicts with federal law is without effect." (citations omitted). The court noted that the purpose of the FDA is to "protect the public health." Therefore, the FDA approval of this opiod is an endorsement of its "safety and effectiveness."  The court concluded that if the states could add or substitute their own requirements, then that "would undermine the FDA's ability to make drugs available and to promote and protect the public health." The court concluded that the public's ability to access this medication was essentially "in the public interest," and granted the injunction against Massachusetts. 

I think I understand this. If the Federal government decides a question of public health, then the states have no right to act contrarily to that decision, even if the state believes that it is acting for the health, safety and welfare of its citizens. Curiously, the order does not address the Constitutional maxim that "police" powers in our system of separation of powers (federalism) are reserved to the states. By definition, police powers are those for the protection of the "health, safety, and welfare" of citizens.

Marijuana was once grown and freely traded in this country. Early in the 20th Century, states began to prohibit its production and sale. Then the federal government acted on it, an it is now a Schedule I drug under the Controlled Substances Act of 1970, classified as having a "high potential for abuse." The Court (that is the United States Supreme Court) has affirmed the "federal government has the right to regulate and criminalize" marijuana. Just another example in which the federal government has acted regarding the public health.

In 2012 Washington state and Colorado legalized recreational marijuana use. One commentator noted that these were "historic" because this is "the first legalization in the world." He notes that there is a misconception that pot is legal in the Netherlands, but that "it is illegal there. They just don't enforce the law." Curious, a government electing not to enforce the law. 

So, when thousands began buying marijuana in Colorado stores and smoking it, surely the outcome would be similar to the Zohydro case in Massachusetts. The federal government has regulated pot, and therefore the states would be as powerless to regulate in any contrary way as they are to regulate Zohydro? 

No, the federal government has apparently made the same decision as the Netherlands. They will not enforce federal law. According to some, the federal government is even "willing to help legal marijuana sales run as smoothly as possible," and will try to encourage banks to deal with pot sellers without consequences they might otherwise face when dealing with drug dealers.  

Do states have the authority to regulate contrarily to federal regulations and codes? These two examples lead to curiosity. The rule seems to be that states cannot ban what the federal government approves by administrative action (Zohydro), but that states are free to legalize and promote what has been forbidden by federal statute. 

Interesting. 



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