House Subcommittee To Markup Track & Trace Draft Today And Tomorrow

draft_partyImportant 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 received a notice yesterday that the House of Representatives Health Subcommittee of the Energy and Commerce Committee will hold a markup session on the most recent track & trace discussion draft that was introduced there last week.  The first discussion draft was published on their website on Monday, April 22, 2013 and the second draft–the one I assume they will markup tomorrow–was published last Friday, May 3, 2013.  It appears that they may hold a vote on the draft after marking it up with any accepted amendments.

The markup sessions will be webcast for your enjoyment.  The first session will be on Tuesday, May 7 at 4:00pm EDT and the second session will be held on Wednesday, May 8 at 9:00am EDT.  You can find the webcast and archive link here.


In addition to these drafts, the Senate also published their own draft on Friday, April 19, 2013 (see “The New Pharma Track & Trace Discussion Draft In The Senate“).  I recently wrote about the House hearing that was related to their first draft (see “The House Hearing on ‘Securing Our Nation’s Prescription Drug Supply Chain’“).  Of course, yesterday I wrote about the response of the California Board of Pharmacy to the recent Senate discussion draft (see, “California Responds To The Senate Pharma Track & Trace Discussion Draft“).  That essay discusses the significance of the apparent softening of the position of the Board toward the language that is in the Senate draft, anyway.  They did not comment on the House drafts.

If I remember my high school civics correctly, these drafts first have to be voted on by the originating subcommittees in each respective “house”.  These votes would elevate the proposed bills to the Committee level where the full committees in each respective house would vote to send them to that house’s floor.  In the House of Representatives, that would be the Energy and Commerce Committee.  In the Senate, that would be the Health Education Labor and Pensions Committee.

If each proposed bill passes its respective house, because the texts differ, a “conference committee” would be organized that would have members from both houses.  This conference committee would be responsible for negotiating a single text from the two original texts that passed the House and Senate.  Once a single text is agreed to, it returns to both houses for a final vote on the resolved bill.  As long as it passes in both houses, the bill is sent to the President for signature.  Once signed, the bill becomes a law and it would be the responsibility of the U.S. Food and Drug Administration (FDA) to implement it within the timetable spelled out in the law.

The current House of Representatives draft is generally considered to be “weaker” than the current Senate draft when it comes to unit-level serialization and other characteristics that both drafts attempt to address.  If both drafts result in bills, and if both bills pass their respective houses, the conference committee will likely resolve each point that is different, somewhere in the middle, which means that the resolved bill will probably be stronger than the current House draft, and weaker than the current Senate draft.

But, there is no guarantee of that.  It is entirely possible that the House subcommittee markup process may result in changes that make the House draft stronger than the current Senate draft.  Unlikely, but possible.  I suppose it is just as possible that the draft could be made even weaker.  We’ll have to watch it and see what happens.  At this point, it is mostly in the hands of politicians and their staffs.

So pop some popcorn, grab a drink.  Let’s have a Draft Party and watch the Health Subcommittee markup session at 4:00pm.