On November 27, 2013 President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“).  That act has many provisions, but one is to preempt all existing and future state pharmaceutical serialization and pedigree laws like those that previously existed in California and Florida.  Because of the preemption language contained within the DQSA, the information contained within many previous RxTrace essays is now obsolete.  Some essays are entirely obsolete and some are only partially obsolete.  This is because many of these essays contain ideas and discussion about topics that will also apply to the new federal law in almost the same way that they applied to the California and/or other state laws that are now inoperative.  In those cases, the ideas and discussion are not obsolete, only their application to the state law(s) is now obsolete.

To address this issue I have created a new banner that I will soon place at the top of every RxTrace essay prior to November 27, 2013 that discusses one or more of these state laws in a significant way.  The banner contains the following text:

“Important Notice To Readers of This Essay

On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law.  That act has many provisions, but one is to preempt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida.  Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete.  It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.

For more information about the federal law that replaced these state laws, click here.”

When readers click the banner they are brought to this essay, “Preemption:  What Does It Mean”.

SO WHAT DOES IT MEAN?

The Wikipedia article on “Federal Preemption” defines two different types of federal preemption of state laws:  Express and Implied.  Express preemption occurs when a new federal law includes explicit language that the intent of Congress is that certain state laws are preempted.  Implied preemption occurs by default through the Supremacy Clause of the U.S. Constitution whenever state and federal law appear to conflict.

For some issues, including those related to federal laws dealing with racial segregation, the Supremacy Clause has been the subject of disagreement over the limits of federal power balanced with the rights of states to govern their citizens.  One of the disagreements over states rights was acted out in the U.S. Civil War.

In the case of federal preemption of state pharmaceutical serialization and pedigree laws, I don’t think there will be any big disagreements considering that one of the roles assigned to the U.S. federal government in the U.S. Constitution is “…To regulate commerce with foreign Nations, and among the several States, and with the Indian Tribes…“.  Who could argue that the U.S. pharma supply chain is not interstate and international commerce?  In fact, I am confident that the state governments that previously had pharmaceutical serialization and/or pedigree laws are now happy that their law has been replaced by a uniform federal law, even though the new federal law may not be as strict as their state law might have been.

IS IT A DONE-DEAL THEN?

Most people in industry are happy about that too.  But all it takes is one person who believes they are harmed unfairly by the new federal law or its implementation for a court case to develop that could delay its implementation.  In some ways, that’s what happened with the Prescription Drug Marketing Act of 1987 (PDMA), the previous attempt by Congress to impose a federal pharmaceutical supply chain pedigree law.  It finally became operational in December of 2006 after quite a few delays only to be challenged in court by RxUSA, a small wholesale distributor, a few days later (see “Impact of RxUSA v. HHS On Future Pedigree Legislation“).  That case never actually resolved the question of fairness raised in the original filing, but it did cause the FDA to back away from enforcing the parts of the law that were challenged.  Those parts are still not enforced today as a result (see “PDMA Lawsuit Resolved?“).

Could the implementation of the DQSA be delayed, partially or even completely blocked by a lawsuit?  Of course (this is the USA after all!), but don’t count on it.

And while we’re talking about the PDMA, the DQSA also preempts that law, but not until January 1, 2015 when it’s lawsuit-crippled provisions are replaced by the provisions of the DQSA that are due to go into effect on that same day.

There is a lot of content that is still valid in these older RxTrace essays.  My hope is that people who stumble upon them are better informed by the new banner and they are able to differentiate the obsolete from still valid content.  And I hope they review the essays I plan to write about the new DQSA and specifically Title II of that law which is the Drug Supply Chain Security Act (DSCSA) going forward from this point.  I will continue to reference these older essays in recognition of the fact that they contain historical information as well as other information that is still pertinent.  I hope others to the same.

Dirk.