The U.S. FDA held their first industry workshop focusing on the new Federal Drug Supply Chain Security Act (DSCSA) last Thursday and Friday at FDA Headquarters in Silver Spring, MD. The goal of the workshop was to help the FDA collect ideas and preferences from industry stakeholders and technology providers for meeting the January 1, 2015 DSCSA requirement to exchange Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS). The FDA must publish a draft guidance document on the same topic before November 27, 2014, so this workshop, plus the responses to the recent docket, will help them write that draft.
The workshop was held in a large room with eleven big tables, each with about 18 chairs around them. The FDA had pre-assigned the seating at each table to ensure that they would all have people seated at them with an even mixture of backgrounds, including pharma manufacturering, wholesale distribution, dispensing, solution providers and regulators. In addition to the FDA facilitator at each table, FDA also provided a scribe at each table.
After a short opening presentation by the FDA explaining the plan for the event, control was transferred to an FDA facilitators at each of the tables. From that point on, attendees each worked within one of those eleven independent but similar groups. The agenda and topics were the same at each table. I am told this is the same format that the FDA used at the last supply chain workshop a few years ago, except that at that time, the facilitators were provided by a consulting firm instead of the FDA. The goal of this type of format is to allow many people to participate, but yet ensure that brainstorming works by keeping the groups just small enough. Ideas collected at the tables were rolled up and reported to the full group several times during the meeting.
During breaks, I heard reports of what other groups were talking about and it sounds like they were remarkably similar to the group I was in. Concerns about ambiguity in the definitions of TI, TH and TS, and about how that information might be exchanged appear to be common and widespread. I think that’s a good thing because it will show the FDA what they should concentrate on and hopefully that will result in rational draft guidance in November. By “rational”, I mean guidance that will smooth the industry’s transition to operating under the first phase of the DSCSA.
The scribes took notes which were then reviewed at a high level with the whole group on the second day. During one discussion on the second day, the organizers asked the tables to discuss other topics for guidances that attendees thought might be helpful, outside of those needed to meet the DSCSA in January. Here is a list of topics I noted from the table report outs:
- Impact of donations to non-501(c)3 organizations on DSCSA compliance
- Definition of “Co-Licensed Partner”
- Sunsetting of the FDA Linear Barcode rule
- Clarification of the appropriate address to use for “change of ownership”
- Format of TI, TH, TS provided to FDA in response to queries
- Drop shipments
- Impact of 340B relationships and product exchange between pharmacies and health systems
- Suspect & Illegitimate product
- Can any member of the supply chain use 3rd party data repositories or only pharmacies?
- How investigational drugs/clinical trial drugs when they are also already approved for other conditions
- Are drugs provided by a manufacturer to patients under a patient assistance program exempt?
- Will it be sufficient for manufacturers to check the FDA’s published list of “authorized” distributors when selling, or will they need to investigate further?
- Do the recent HDMA EDI ASN guidance meet the FDA DSCSA requirements?
- How should companies correct TI, TH, TS when honest mistakes/errors are found?
- Additional time/enforcement discretion because there will be so little time between the publication of the FDA guidance and January 1, 2015
- Help getting states to recognize that their pedigree laws have been preempted
- Exactly what it means to “take ownership”
- Acceptance of abbreviated forms of the TS language and dosage forms
- A full list of Combination Products that must meet the DSCSA
- How Law 75 in Puerto Rico impacts the wholesale distribution of drugs under the DSCSA
That’s quite a list. As you can see, it includes some things that you would expect the FDA to address in their guidance for standards for the interoperable exchange of TI, TH and TS, but many other topics are outside of that coverage. The FDA isn’t making any promises, but perhaps we will see additional guidance, or at least some Frequently Asked Questions (FAQs) around some of these things in the next few years.
During the full group reports and discussion I heard a couple of new abbreviations for the Transaction Information, Transaction History and Transaction Statement. Of course, no one really uses the full words more than once. Many people have been using “TI, TH and TS” as abbreviations, but even those take a long time to say when you are speaking. One speaker used the term “three-Ts”, and another used the term “T3” to mean the collection of all three. Back in October of last year I started to refer to the collection of these three documents as “TransX”, but that didn’t catch on. I’ve heard another company is using “TD” to refer to all three, as in “Transaction Data” or “Transaction Documents”.
For fun, help me figure out the “right” abbreviation. Please complete this fun, 2-question survey on the topic. Instant results “so far” will be displayed after you complete the survey. I will report the final results in a future essay.
We won’t know the full outcome of this first DSCSA workshop until the FDA publishes their draft guidance in November. And by the way, Dr. Connie Jung told those in attendance that the FDA recognizes the industry needs the guidance as soon as possible and they will make every effort to publish earlier than the November 27 date. The way I see it, they have a lot to digest, understand and react to between now and then, so don’t hold your breath.