Senators Propose Amendments To S. 959-RX Trace

As many of you pointed out to me in private emails last Friday after I had claimed that things had been quiet, there had indeed been some significant activity on S. 959, “Pharmaceutical Quality, Security, and Accountability Act” (PQSA) that occurred last week.  Even though the bill was awaiting action on the Senate floor, the bill managers in the Senate are apparently able to pull it back and amend it, and that’s what they did.  The bill is a combination of the “Pharmaceutical Compounding Quality and Accountability Act” and the “Drug Supply Chain Security Act” and my interest is in the latter so I will limit my analysis to that part of the current bill.

The amendments are fairly light and sprinkled throughout.  Most have little to no affect on the meaning or implementation of the bill–these include reformatting, corrections and minor logical adjustments–but there are a few things that are notable.

Most significantly, manufacturers would be required to provide their transaction information, transaction history, and transaction statement in a single document only in electronic formstarting 4 years after enactment.  Prior to that point they could provide it in either electronic or paper form.  What’s interesting about this change is how it would trickle down the supply chain.

On the surface you would expect that the authors of the bill would need to include a similar requirement on the wholesalers, dispensers and repackagers, but they did not do that.  It is not necessary because, wholesalers were already required to receive that information from the manufacturer.  Once the manufacturer can only provide it in electronic form 4 years after enactment, then wholesalers must be able to receive and store it electronically to remain in compliance at that same time.

Once wholesalers begins to receive the transaction information, history and statements from the manufacturers in electronic form it appears that the bill would allow them to convert them to paper whenever they need to pass them on to their customer.  That is, at least until the enhanced drug distribution security provisions would kick in 10 years after enactment.  By that time, everyone would have to create, store and exchange these documents electronically.

But this brings me to the next significant amendment to the bill.  There is a new and poorly worded section under the Product Tracing section called “Trading Partner Agreements”.  The section says:

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