InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives

Seal_of_the_United_States_House_of_RepresentativesImportant 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.Late yesterday The Hill, a political news website, began reporting that the U.S. House of Representatives has passed H.R. 1919, Safeguarding America’s Pharmaceuticals Act in a voice vote that required a two-thirds majority vote.  I was watching the House floor streaming feed live as it happened and I must admit that the parliamentary proceedings were slightly confusing to me regarding the vote, so now that The Hill is reporting passage I feel more comfortable saying the same thing.  😉

The text of the bill as it was before the vote appears here.

During the debate leading up to the vote, a letter from the California Board of Pharmacy was placed into the record in opposition to the bill.

“…we believe H.R. 1919 does not promise the kind of robust supply chain security that is necessary to ensure adequate patient protection, and is not an adequate replacement for the California pedigree law…”

See the full text here.

As I understand it, the bill will now be sent to the Senate where they will recognize that it is similar, but not the same, as their bill S. 957, The Drug Supply Chain Security Act.  I believe the Senate will take action on their bill first at some point in the next month.  The process from that point on is a little foggy to me so someone correct me if I’m wrong.  If the Senate fails to pass their bill they may then consider the House bill as it is today.  If it passes, it would go to President Obama for consideration.  The President may sign it, not sign it or veto it.  If he does not sign or veto it within 10 days, it becomes law anyway.

But if the Senate passes their bill, the managers of the House and the Senate bills will form a “Conference Committee” to negotiate a single bill text.  The result may look more like the House bill, or more like the Senate bill, or it might look like some combination of the two.  If the Conference fails to agree on a single text before the Congressional session ends in September all of the work that has been done on the bills in both the House and the Senate will be wiped away and proponents would have to start all over again in the new session if they wish to.

But if the Conference Committee can agree on a single text for a bill, both the House and the Senate would vote on that version.  If that bill fails to pass in either house, it fails permanently for this session.  If it passes in both houses, the bill would be sent to the President for consideration.

It must be very difficult for any politician to go on record voting against either of these bills.  That’s why the voice vote made sense in the House where it was fairly obvious that the supporters outnumbered the dissenters.  The Senate bill will likely pass too.  In my recent essay about the politics of this bill (see “The Politics Of Federal Track & Trace Legislation”) I pointed out that the Senate bill was the more bipartisan of the two.  I don’t know what affect that will have on the outcome of the Conference Committee.  Assuming it gets that far, we will just have to wait and see.  However, if any of these bills reach the President’s desk I am fairly confident that he will sign it.

Next stop, the Senate.  As far as I know right now the Senate has not yet schedule action on their bill.