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Waiting For The Senate To Act On A Track & Trace Bill, Again

us-senate-logoImportant 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. House of Representatives made quick work of the new bipartisan, bicameral compounding and track & trace bill draft that was circulated only last Wednesday evening (see “InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill”).  They interrupted their debate over defunding “ObamaCare”, the Patient Protection and Affordable Care Act (PPACA), for a quick voice vote on the newly numbered H.R. 3204, Drug Quality and Security Act (DQSA) and it passed (see the draft bill here).

So now we are waiting for the Senate to take action, just as we have for the last 3 months since the House of Representatives voted to pass their earlier bill with drug supply chain track & trace provisions, H.R. 1919, Safeguarding America’s Pharmaceuticals Act, back in June (see “InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives“ and “Still Waiting For The Senate”).  The Senate had their own, different bill, S. 959, Pharmaceutical Compounding Quality and Accountability Act, at that time and it made it to the Senate floor but no action has ever taken place on it (see “InBrief: A Track & Trace bill Has Made It To The Senate Floor“).

But everything is different now and the prospects for this new bill becoming a law are higher than the previous attempts.  Why?  The managers of the two different bills from the House and the Senate and their staffs got together over the August recess and worked out a single text compromise bill—the one that was distributed last Wednesday and the one that just passed the House on Saturday without amendment.  That’s key because an amendment would cause the text to deviate from the one that the managers agreed on and that would cause the other chamber to have to consider the amended bill.  The House managers have done their part by introducing and the House passing the new text.  Now it’s up to the Senate.  I’m told they don’t work as fast so don’t expect such quick action from them.

HOW THEY DID IT

You might remember that there were significant differences in the track & trace provisions of H.R. 1919 and S. 959 (see “The Politics Of Federal Track & Trace Legislation”), but the biggest difference was that S. 959 included an entire section devoted to regulating compounding pharmacies while H.R. 1919 had nothing like that.  Shortly after the House returned to business after their August recess they introduced H.R. 3089, the Compounding Clarity Act that would regulate compounding pharmacies, but it took a different approach than S. 959.  I have not analyzed the compounding provisions myself but I highly recommend Alexander Gaffney’s excellent article in Regulatory Focus “House Version of Compounding Legislation Emerges, Contrasting Sharply With Senate Approach”.

When the new H.R. 3204 draft emerged last week, it appeared that the recess compromise took the track & trace provisions from S. 959 and combined them with the compounding provisions from H.R. 3089.  Unfortunately I haven’t had time to analyze it all to this level so I rely on the Regulatory Focus’ analysis.

THE AFFECT ON LAST WEEK’S CALIFORNIA BOARD OF PHARMACEY EPEDIGREE COMMITTEE MEETING

The new draft that would quickly became H.R. 3204 was circulated on Wednesday evening last week.  On Thursday morning I published an essay about it (see “InBrief: Important New Bicameral Draft Of A Pharma Supply Chain Security Bill”).  Later that morning, the California Board of Pharmacy held their scheduled ePedigree Committee meeting.  Many of those in the room were RxTrace readers, but there were also a number of insiders in the room who had first-hand news of the activities of the Pharmaceutical Distribution Security Alliance (PDSA), the industry lobbying group that has worked with the bill managers to get this legislation through both houses of Congress.  News of the new draft was on everyone’s lips before the meeting even got started.

After the meeting began, the committee chair, Randy Kajioka, referred to the new draft that was being circulated at the time and mentioned that he had heard the House may vote on it as early as Saturday (which is exactly what later happened).  He reminded those present that until a bill passes both houses of Congress and is signed by the President, their law is still in effect and it is business as usual for the ePedigree Committee.  However, it seemed to me like the Committee was just going through the motions of holding their meeting without wishing to drive any farther down the ePedigree path.  After all, even the California Board of Pharmacy believes that the right way to improve the security of the California pharma supply chain is for there to be a strong federal law, not a state law.  The air in the room seemed to be that the long journey those present had taken together was about to come to an end.  The meeting concluded shortly after noon.

WHAT WILL HAPPEN NEXT?

It’s hard to predict what will happen in the Senate considering that the compounding industry is fighting back aggressively and some are not very happy with the fast action of the House (see another excellent Alexander Gaffney article from yesterday, “House Passes Compounding and Supply Chain Reform Legislation, Even as Some Groups Cry Foul”).  Some are predicting fast action in the Senate too.  You have to wonder, is the drama over the funding of the government and defunding the PPACA being used as cover since the Congressional communication lines are probably clogged with people complaining about those issues?

I mean, considering what has been swirling around Washington this week—including the very reason the House was at work on Saturday—wouldn’t you have expected the House Republicans to ceased on any bill right about now that has to do with healthcare by inserting a provision that would defund the PPACA, just as they have done in the bill to keep the government funded?  Instead, the bill sailed through.  I’m glad it did, but it just seems a little odd to me.

Unless the compounding portions of the bill generate pushback from one or more Senators, it is likely that this bill will pass the Senate without amendment.  In that case, it will almost certainly be signed into law by President Obama.

So here we are again, waiting for the Senate.

Dirk.

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One Response to “Waiting For The Senate To Act On A Track & Trace Bill, Again”

  • Matt Sample says:

    Dirk,

    Thanks again, as always, for the update & perspective. As we all start assessing what this means for our individual companies and programs, one question I have that I can’t draw a firm conclusion on is “what does this mean for aggregation?”.

    One one hand I can interpret the Federal bill as not requiring aggregation until 2023 as an enabler for unit level tracking. On the other hand, I don’t know the details of verification and if I’m required to manage status changes of my serial numbers while in my ownership (Destroyed, Sampled, Recalled, etc)… if the answer to the later is YES, then I need aggregation to support my 2017 requirements.

    Any thoughts?

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About The Author
Dirk Rodgers

Dirk is an independent consultant and founder of RxTrace. He has contributed to many of the industry groups that have been formed over the last 10 years to investigate solutions to the problem of counterfeit and other illegitimate drugs in the legitimate supply chain. He served as co-chair of a number of key technical work groups in GS1 and GS1 US. These include the original GS1 EPCglobal Drug Pedigree Messaging work group that created the DPMS pedigree standard, the Network Centric ePedigree (NCeP) work group and the RFID Barcode Interoperability Guideline work group. Dirk holds a BS in Electrical and Computer Engineering from the University of Wisconsin-Madison.

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