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 form starting 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:
“TRADING PARTNER AGREEMENTS.— Beginning 6 years after the date of enactment of the Drug Supply Chain Security Act, a wholesale distributor may disclose the transaction information, including lot level information, transaction history, or transaction statement of a product to the subsequent purchaser of the product, pursuant to a written agreement between such wholesale distributor and such subsequent purchaser.”
This is confusing because, according to other parts of the bill, the wholesaler would already be required to provide the subsequent purchaser–and all subsequent purchasers would be required to receive–the transaction information, history and statement on a single document in an electronic or paper format, so why would the bill also allow the wholesaler to enter into an agreement with the subsequent purchaser which would determine whether or not this information is disclosed to them (note the words “may disclose“)? Are we missing a word or two in this new provision that would make it more clear? A copy and paste error perhaps? Would the written agreement simply specify in which format the subsequent purchaser would receive the data? Could the words “to the subsequent purchaser of the product” have been intended to be “to parties other than the subsequent purchaser of the product“? Can anyone explain this provision?
A few other changes to the bill include:
- Homeopathic drugs were added to the list of overall exemptions;
- Drug products (including repackaged products) that are required to have a Standardized Numeric Identifier (SNI) are not required to have a Unique Device Identifier (UDI);
- Until 4 years after enactment, dispensers would be granted additional time as necessary to provide lot level information that was originally provided to them in paper format in response to an information request;
- A wholesaler would be required to maintain the confidentiality of transaction information, history and statements provided to them except as required by the other provisions of the bill. Why does this requirement not cover all parties in the supply chain?
WHAT COMES NEXT?
I’m definitely not an expert on the varying arcane paths legislation can take to become a law. I thought these amendments would just be incorporated into the bill that the full Senate votes on, perhaps later this week, but Alexander Gaffney of Regulatory Focus says that the bill now needs to return to the Senate Health Education Labor and Pensions (HELP) committee to be passed again before it can proceed back to the Senate floor. That’s a little surprising to me, but unless he is mistaken, this is going to take a little longer than anyone expected.