On the FDA Public Workshop
A review of the public workshop in Silver Spring, Maryland, covering the Standards for the Interoperable Exchange of Information for Tracing of Human, Finished, Prescription Drugs, in Paper or Electronic Format
I had the pleasure of attending the Federal Drug Administration (FDA) public workshop along with Hristo Todorov, Product Manager for Axway’s Track and Trace solution. We met several Axway customers at this event and were able to collaborate with them during breaks. Below are a few key takeaways from the workshop:
- For the January 1, 2015 deadline, the general preference is ASN EDI or web portal (hiding the EDI setup). Also, everybody agrees paper-packing slips will be necessary. EPCIS might see limited usage between manufacturers and Tier 1 wholesalers, but between Tier 1 wholesalers and lower-level wholesalers or distributors, EPCIS isn’t desired, as they currently use EDI to exchange this information. The distributors (the small ones) prefer a wholesaler-run web portal, but there is also concern that they will end up going to multiple web portals, which may cause confusion. Ideally they will prefer a solution that is a “network” of cloud service, where you have zero setup with partners for the ASN EDI. One fills out the Transaction Information (TI, i.e., the names of the receiving business and personnel) and ASN EDI knows where to send the information. The smaller distributors prefer contracting somebody else (e.g., somebody upstream) to provide a portal and storage for data (primary Wholesale Dispenser [wd2]).
- There is a still lot of confusion about the elements of the Transition Statement (TS), Transaction History (TH), and TI. The FDA has been asked by various groups to further clarify these elements with examples.
- A GS1 representative, Bob Celeste, made several statements on the EPCIS usage and what EPCIS can provide in the long term. Most of the audience didn’t realize that EPCIS is a query language that allows partners to communicate and request information on demand. It is not just a data storage format; it also supports the consumption of information throughout the supply chain.
- Currently, both manufacturers and WD1 say ASN is five percent of the transaction volume, but about 85 to 90 percent of the product volume, so they see no reason to change.
- There was also a discussion of using email as a means to exchange packing slips among low-tech or no-tech companies. Several folks were concerned that email is not secure and that it might open up the possibility of the FDA auditing all email exchanges. One suggestion for getting around these challenges was to use a secure email exchange system that is separate from the corporate email server.
Overall, after attending this workshop, I realized that the drug supply chain will have a mix of EPCIS and ASN usage. Customers will need a solution that can help them deal with both of these data formats, as well as the one that supports serialization, to meet the end goal of the DSCSA.