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.

The draft is an updated and filled out version of the “Mad-Libs” draft that was released by the same committee last October (see “Congressional Legislation Development: Mad Libs Edition!”, and “More Thoughts On The Congressional Discussion Draft”).  Apparently the game is complete and the full text can now be read.  😉

A few things have been rearranged and a few things are gone.  The Federal licensing of wholesalers and third-party logistics providers (3PLs) remains, and enactment of the Bill would still result in immediate preemption of all state pedigree laws.  The interim lot-based pedigree remains in this draft and the full serial number-based track & trace system would be delayed until 10 years after enactment of the legislation.

The HELP Committee is asking for you to submit comments about the draft to them by the end of this week so you had better act fast.  What’s really interesting—and what leads me to think this could be the time that something will pass—is that the House of Representatives Energy and Commerce Committee has scheduled a hearing on “Securing Our Nation’s Prescription Drug Supply Chain” for this Thursday at 10am.  I’m assuming that the House will introduce the same, or similar bill as the Senate HELP Committee draft.  If that happens, I’m assuming these bills will each eventually pass their respective houses.  That’s a lot of assumptions, and I don’t have any inside view of what has been going on, but considering that this draft has been worked out between key congressional staffers and industry lobbyists, what would cause a Congressperson to oppose it?

I would normally provide you with my detailed assessment of this new discussion draft before the end of the comment period, but the timing is not good for me because of several long-standing family commitments.  Instead, I will plan on reviewing the Senate discussion draft and the House hearing together next week, probably not until Tuesday.  In the mean time, I have an essay on California’s draft regulation on Inference that was originally prepared for today.  Look for that one tomorrow and another one on their draft regulation on Inspections next Monday.

If you need some help understanding some of the contents of the latest Senate discussion draft, make sure you read my earlier essays from last fall (linked above).  Most of that content is still valid.