Tag Archives: federal preemption

Would A U.S. Federal Pedigree Law Require A New UFA?

Bag-O-MoneyOne of the questions that must be answered is, “how will an ePedigree and track & trace system be funded?”.  Who pays, who gets paid, and how much?  The answer to these questions are partly determined by which technology model is in use.  One reason a distributed model is usually the first model people think of is that the funding is so obvious:  it is localized.  In that model each company would arrange for their own services.  No pooling is needed.  That’s simple to understand and quantify because everyone is in control of the services they need.

But because distributed models have so many points of failure—any one of which would Continue reading Would A U.S. Federal Pedigree Law Require A New UFA?

The New Pharma Track & Trace Discussion Draft In The Senate

A discussion draftImportant 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 pre-empt 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.The U.S. Senate Health, Education, Labor and Pensions (HELP) Committee released a new discussion draft last Friday of a bill that would preempt all state pharmaceutical ePedigree laws and establish a pathway toward a nationwide track & trace regulation.  Take careful note of this one.  It could be the one that finally makes it.  Let me explain. Continue reading The New Pharma Track & Trace Discussion Draft In The Senate

Will The California ePedigree Dates Slip Again?

Coastline near Laguna Beach California, November 2009. Photo by Dirk.
Click to enlarge image.

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 pre-empt 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.Everywhere I go lately I am asked “Do you think the California ePedigree dates will slip again?”.  I don’t have any special or inside knowledge but, as usual, I do have a theory about that.  I offer it to you here as one possible outcome.  You can decide for yourself if you think it is dubious, merely plausible, fully probable, or somewhere in-between. Continue reading Will The California ePedigree Dates Slip Again?

More Thoughts On The Congressional Discussion Draft

You now have less than one week to provide a group of Congresspeople with your thoughts on their latest discussion draft for a bill that would attempt to make our U.S. drug supply chain less susceptible to criminal attacks and errors.  See my two earlier essays, “The Congressional Draft Proposal to Improve Drug Distribution Security” and “Congressional Legislation Development: Mad Libs Edition!” for more specifics.

Perhaps the aggressiveness of the response date is a reflection of how important this piece of proposed legislation is.  That is, if you think it is important, then you will immediately drop whatever it was you were doing and get right to the task of providing a detailed reply so they can make sure the final draft reflects your preferences.  I don’t know what you’ve been up to, but this is my third essay about it.  😉

There are still a few things that I wonder about. Continue reading More Thoughts On The Congressional Discussion Draft

Congressional Legislation Development: Mad Libs Edition!

I’ve now finished studying the latest Congressional Discussion Draft to Improve Drug Distribution SecurityAs promised last Thursday, here is my analysis.  Overall I’d say it is a very serious attempt to develop a raw text that everyone can agree on.

But the only reason everyone can agree on it is that there are literally hundreds of multiple-choice options (they call them “policy choices”) built in–kind of like Mad Libs.  Anyone can use a marker to go through and cross out all the choices that they don’t like and they would end up with a bill that their constituency would probably accept.  The problem is Continue reading Congressional Legislation Development: Mad Libs Edition!

PDUFA Will Not Include RxTEC

Politico.com reported today that the national track and trace addendum that many hoped would be made part of the Prescription Drug User Fee Act (PDUFA) of 2012 was rejected by the U.S. House and Senate Conference Committee.  That committee is working on merging the differences between the versions adopted by the two Houses of Congress into a single bill.  See “’Track And Trace’ On Ice For Now” in Politico PULSE.

According to Politico, “The word emerged late Sunday night from congressional staffers working on the package who said a last-minute compromise effort failed to win the support of stakeholders, and a decision had been made to drop it — for now.”

Assuming there isn’t a last minute reconsideration, this means that the odds are now slim that a national regulation will preempt the California pedigree law before its effective dates.  The remaining chance comes from the fact that the industry is well organized and well represented by the Pharmaceutical Distribution Security Alliance (PDSA) and could decide to back the introduction of a stand-alone bill that contains the essence of the Pharmaceutical Traceability Enhancement Code (RxTEC) language that was part of the PDUFA negotiations, or some other proposal.  The success of such an approach likely depends on Continue reading PDUFA Will Not Include RxTEC

The Preemption Provisions Built Into The California Pedigree Law

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 pre-empt 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.In this time of potential Congressional legislative action on drug track and trace I think it is time to take a closer look at the specific provisions contained in the current California pedigree law regarding Federal preemption.  As I recall, this language was added in the most recent update of the law, the same update that pushed it out to 2015 – 2017.  It is an invitation to the federal government to create their own national pedigree regulation and, if that happens, would cause the California pedigree law to become “inoperative”, thus preempted.

Here is the full text of section 4034.1 from the California Business and Professions Code: Continue reading The Preemption Provisions Built Into The California Pedigree Law