The Congressional Draft Proposal to Improve Drug Distribution Security

Yesterday I received several notices of the latest attempt to introduce a national drug supply chain security bill into Congress.  That is, the publication of a discussion draft produced by the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee.  Download it in PDF form from Senator Harkin’s website.

I wanted to get this notice out this morning but I won’t have a full analysis until my Monday essay.  Stay tuned for that.

The email I received included the following explanation from Kathleen Laird of the HELP Committee:

Policy Options Draft for Stakeholder Discussion

This discussion draft reflects an ongoing effort to develop consensus policy on drug distribution security. This draft contains brackets and a menu of policy options for some issues around which developing consensus is most challenging. Chairman Harkin and Ranking Member Enzi of the HELP Committee, Chairman Upton and Ranking Member Waxman of the Energy and Commerce Committee, as well as the offices of Senators Bennet, Burr, Alexander, Whitehouse, Grassley, and Feinstein, and Representatives Dingell, Bilbray, Pallone, and Matheson request that stakeholders provide written responses indicating and explaining the preferred policy options, where applicable, as well as any other comments to the draft proposal.

Please submit your written comments by 6pm on Wednesday, November 7, 2012, to each of the following:

There are literally hundreds of policy options in brackets, and with a short deadline for comment submissions–only two weeks!–you’d better get started right now if you plan to submit comments on time.

I’ve buzzed through the draft once so far and it looks like a bit of an amalgam of a number of previous proposed bills.  It starts out as a case-level lot-based pedigree (the loaded word “pedigree” isn’t really used in the document) that includes product identifier (serial number-based) authentication (called “verification” in the draft).  But then, over time, it all transforms one way or another into a full unit-level serial number track and trace (more trace than track) or pedigree system.

Watch for my full analysis on Monday.


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