InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill

US CapitolImportant 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.I just arrived in California a couple hours ago to attend the next California Board of Pharmacy ePedigree Committee meeting later this morning.  I was expecting to check into my hotel and go to bed, but as soon as I turned my phone back on I received multiple notices that a new bipartisan, bicameral draft of a pharma supply chain security bill was being circulated for review and comment.  The email from the Senate HELP Committee was timestamped at 9:54pm EDT on Wednesday and they want people to comment on it by noon on Thursday.  Wow.  I still hope to get some sleep tonight, but I wanted to post this essay along with the PDF in case you didn’t receive it.

You can find a copy of the draft here.  And here is a press release that talks about it.

[UPDATE:  Latest official House version here.]

Because the draft is apparently agreed to by the bill managers of H.R. 1919, which passed the full House back in June (see “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives“), and S. 959, which was currently awaiting floor action in the Senate after being passed by the HELP Committee back in May (see “InBrief: A Track & Trace bill Has Made It To The Senate Floor“), everyone expects this new draft to replace those two bills.  This new draft will be assigned its own number once it is formally introduced into the legislative process.  It’s obviously on a fast track, to say the least.

The new draft is a compromise between the bill managers from the House of Representatives and the Senate–that’s what makes it bicameral–and there isn’t any partisan split in opinions–that’s what makes it bipartisan–so for the first time since the summer of 2012 we have something that has a high likelihood of passing (see “The Politics Of Federal Track & Trace Legislation“).  At least that’s my personal and remote observation.

ENOUGH ABOUT THAT, WHAT IN THE NEW DRAFT?

Sorry, I’m too sleepy to compare the new draft line-by-line so I cannot give you a full list of differences between H.R. 1919 and S. 959, but I will say that the specific elements I looked for in the new draft matched those of S. 959.  That’s not surprising considering the fact that the California delegation and the California Board of Pharmacy were so opposed to H.R. 1919 as being an insufficient replacement for California’s state law.  I also viewed H.R. 1919 as something less than advertised (see “An Industry Protection Bill Concealed Under The Veil Of Patient Protection“).

Here is a list of elements that were in S. 959 and are also in this draft:

  • Self-executing: “…the requirements of this section may be enforced without further regulations or guidance from the Secretary“.  This was not in H.R. 1919;
  • Serialization of all drug packages and cases 4 years after enactment.  In H.R. 1919 it was 5 years;
  • Full interoperable, package-level serialization-based track & trace system in 10 years after enactment, although it was recently pointed out to me that in that system, transaction histories would no longer be required.  This new draft words it in a different way but it seems to end up being the same result.  This requires closer inspection.  H.R. 1919 did not have the equivalent but there was a mushy ability for new proposals to be made after 14 years;
  • The SNI, lot/batch and expiration date must be encoded “…in a 2-dimensional data matrix barcode when affixed to, or imprinted upon, a package…” and “...in a linear or 2- dimensional data matrix barcode when affixed to, or imprinted upon, a homogeneous case...”, but the FDA would be allowed to specify other technologies;

In every new draft, the exemptions seem to get longer and more intricate.  I suggest you have close look to confirm what is new and what was there in the earlier drafts.  If it becomes law I’ll try to do an essay on those exemptions that make it in.

This draft could progress quickly so keep an eye on it.  You can bet I will.

Dirk.