I was fortunate enough to have attended the latest in the FDA’s public meetings discussing the Drug Supply Chain Security Act (DSCSA).
The focus of this specific event was to allow those impacted by the law to make representations on progress and share learning to date. Therefore, the event consisted of a number of presentations, some with slides and some deliberately without.
In terms of speakers, there was a good cross section of the impacted supply chain, including:
- The FDA themselves
- Rx Manufacturer – J&J
- Generic manufacturer’s association – GPhA
- 3rd party logistics: UPS
- The wholesalers: HDA, AmerisourceBergen & McKesson
- Pharmacies: PDSA
- Suppliers: Optel Vision.
There was a lot discussed, some of which I will go into in more detail in separate blogs in the next few weeks. In the meantime, here are the messages that stood out for me.
I would characterise the overall message from the speakers as follows: It’s very difficult; We are trying hard; We need some FDA guidance in specific areas; We will probably need more time to implement.
As yet, the FDA has not published any guidance to State licensors. It was reported that some proactive States are changing their licencing rules in line with what they believe is required by the DSCSA. However, in the absence of FDA guidance on this topic, there are inconsistent requirements being implemented. There was a plea from several speakers for the FDA to issue guidance as soon as possible.
There were lots of calls from the presenters for the clarification guidance from the FDA on grandfathering. The FDA simply stated that guidance was being developed and would be published sometime.
There was a lot of confusion reported on how to encode product NDCs into GTINs. It seemed that this issue was mainly originating from product produced in India and destined for the US market. Initial GS1 India guidelines appear to have been open to interpretation and have caused incorrect coding. There were several requests for clarification on this from the FDA. For those in confusion, I suggest reading the GS1 US guidance on the subject.
Wholesalers are clearly concerned about the use of the term “transact” in the DSCSA regarding the 2019 deadline. Does it mean buy and/or sell/re-sell and/or return?
Several presenters spoke of the need for the FDA to provide additional guidance on topics in the form of ”guide rails”, i.e. don’t tell us “how”, but do put guidance in place that sets the boundaries of “what”. However, nobody gave the FDA much in the way of hints as to what guide rails they wanted.
Astellas and J&J informed the FDA that they are investing in aggregating everything from day 1. A number of our clients are doing the same thing, in which case they are not exposed to any risk associated with not aggregating.
All the wholesaler presents talked about their learnings from piloting: However, the HDA was basically keeping their powder dry, as they intend to release their results at their November annual HDA conference. McKesson and AmerisourceBergenn (AB) were both more forthcoming, presenting findings from their individual pilots. The messages that stood out to me were:
- They have been focusing on the transaction from Manufacturer to Wholesaler so far in pilots.
- They were all emphasising that they will need aggregation and inference, so need guidelines on it fast.
- With 60 million returns per year, there was a clear emphasis on data being needed to support returns verification activity in 2019.
- It’s a lot more complex than they thought to manage both exceptions and the complex variations in which products move.
- AB are going to be doing more piloting (with 12 manufacturers, 50-100 skus & 4 DCs) in Q1 2017, focusing on:
- Wholesaler to Pharmacy transactions.
- Exceptions, e.g. Data, no product; Product, no data; Packaging/labelling issues.
- McKesson will publish another letter early in Q1 2017, clarifying some things from the previous letter and issuing guidance on implementation.
- GS1 US announced their upcoming DSCSA implementation guidelines
More to follow in the next couple of weeks.
Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me at Stephen.McIndoe@be4ward.com.
Available for request:
For more information on serialisation, go to our free download section.