Sponsored: FDA DSCSA Public Meeting Q&A

The two days after the next FDA DSCSA Public Meeting, IQPC will hold their Pharmaceutical Traceability Forum | Interactive event in Washington DC.  The FDA meeting will be on December 5 and 6, and the IQPC event will be on December 7 and 8.  Perfect for attending two vitally important meetings, and only having to travel once.  The Pharmaceutical Traceability Forum | Interactive event includes a slate of excellent speakers who will provide you with their immediate impressions of the FDA meeting that will have just occurred, and the one that was held back in August (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”).

But you don’t even have to wait, because IQPC has interviewed several of their speakers to find out their impressions of that August meeting.  Here they are:

IQPC:  What major DSCSA updates did the FDA share during this workshop, if any?

  • “The focus was on discussing the FDA vision for 2023”

  • “They clearly stated that they would want to see DSCSA expand beyond what is required from the statutory requirement to better overall patient safety such as electronic medical records, improved recall effectiveness, and even alluding to scanning products at dispense.”

  • “The FDA shared their vision for 2023.  Their vision goes beyond the statutory requirements and puts patient safety as a priority.  The vision clearly goes beyond the scope of the law and was shocking to many in attendance.” 

IQPC:  What were the top concerns shared by the industry?  How did the FDA respond to those concerns?

  • “The largest concern—primarily from the dispensing community—was the implied idea that they had to scan the serialized product and possibly provide data back somewhere, or integrate with EMRs.  There is nothing in the current DSCSA law that prescribes that dispensers have to scan and do anything with the data.  There are 200,000 dispensers, and many don’t have 2D scanners or technologies to achieve this larger vision beyond DSCSA.”

  • “The FDA vision in general was a concern.  We are still trying to meet ‘18, ‘19, ‘20, and ‘23 requirements and this seemed to introduce something well beyond that.  There are concerns with the right level if information sharing.  They essentially said this was a brainstorming session.” 

IQPC:  How did the concerns differ between manufacturers, wholesalers, dispensers, CMO’s, etc.?

  • “The general concerns from the manufacturers was around aggregation and the potential issues.”

  • “One of the wholesalers spoke up acknowledging the value of inference in operational efficiencies and indicated they believed when (not if) an exception occurs, that there are certain models where verification should be considered a good approach to keep good product moving forward.”

  • “The dispensers were clearly concerned about the implied requirements beyond DSCSA.”

  • “Generally all supply chain members voiced concern over the missing guidance documents.”

  • “It was the same themes – is aggregation needed, where is the data stored, 1 up 1 down vs full system visibility.”

IQPC:  Were there any new players at the meeting that were not significantly involved before, i.e. 3PL’s?

  • “APhA (American Pharmacists Association) was a new player that I didn’t recognize before.”

  • “3PLs weren’t there specifically, but several wholesalers are also 3PLs and represented those concerns.”

  • “It looked like many of the same people.”

IQPC:  What action points did the meeting leave you with to implement in your own operations?

  • There really was no discussion around the 2023 solution, so from an implementation and strategy perspective we’re staying on point.”

  • “As a company, we wanted to make sure that we have our technical people prepared to attend the December meetings.  There was nothing new that spurred any new or varying action on our part.”

IQPC:  What are you most looking forward to in the next FDA workshop and our forum to follow?

  • “I’m looking forward to getting into the tactical discussion of what the ‘interoperable’ system is and looking at the viable option.  Right now I’d argue that the ‘solutions’ we’ve been piloting certainly allow us to provide serialized TI data to our trading partners, but it really isn’t interoperable amongst trading partners.”

  • I’m looking forward to the IQPC forum as a place for supply chain members to decompress and discuss what we heard, concerns, and potential next steps.”

  • “To understand what we need to do in order to the 2023 requirements.  I think a debrief at the forum afterwards will allow all parties to share their perspectives.”

The IQPC Pharmaceutical Traceability Forum | Interactive event falling immediately after the next FDA DSCSA Public Meeting ensures that attendees will get a full perspective on where the industry is headed, and where the FDA wants it to go. 

Take a peek at who you can expect to network with on-site based on IQPC’s current attendee snapshot http://bit.ly/PTForumAttendees.  Contact Terence.Wu@iqpc.com to find out more on exclusive sponsorship opportunities available to network with IQPC’s high-level audience at this year’s event.

Dirk.

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