Last week, Connie Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Office of Drug Security, Integrity, & Recalls, U.S. Food and Drug Administration, spoke about the Drug Supply Chain Security Act (DSCSA) at the GS1 US Connect event in Washington DC. This was our latest opportunity to get a glimpse of what the FDA is thinking and what they are doing. Dr. Jung spoke for about 50 minutes and then answered questions from the audience.
Dr. Jung’s formal presentation was similar to those she has given at earlier events but she also included a few new slides. The actual content was little changed from previous events. She reviewed the DSCSA at a high level, including the timeline (see “Decoding The FDA’s DSCSA Timeline”). She discussed the execution of the FDA Pilots Workshop back in April, reviewed its objectives and the results they collected (see also “The 2016 FDA Pilots Workshop” and “HDMA Responds To FDA Pilots RFC”). She discussed the existing draft guidances that the FDA has published related to the DSCSA (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”, “FDA Posts Guidance For Wholesale Distributor and 3PL Annual Reporting”, “The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA”, “The FDA’s Draft Guidance on Suspect Product, and Farewell Columbus”).
Dr. Jung said that the FDA has not heard of any issues about the lot-level exchange of TI/TH/TS lately so they believe things are going smoothly. Regarding suspect product, she said that they have published draft guidance on how to identify it, and also the process to notify FDA when illegitimate product is discovered. They received comments on that guidance so there might be a few changes when the final guidance is published. They expect to publish that guidance “soon”.
It sounds like the FDA will likely make a few unspecified changes to the illegitimate product notification form that had been included in the draft guidance on Suspect Product and Notifications. Dr. Jung thanked those who have created the form themselves. She expects the final guidance to contain an updated form that is “more user friendly”.
Dr. Jung stressed that the industry must move to fully electronic data exchange in the coming years. She said that, after FDA put GS1’s Electronic Product Code Information Services (EPCIS) on the list of acceptable data exchange technologies in their draft data exchange guidance in November, 2014 (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”), they heard through an informal poll and general comments that the adoption rate of EPCIS was very low at that time. She is hopeful that the adoption rate will go up by the time they do another poll. She was encouraged by what she heard while attending the Connect event.
She was also very encouraged by what she heard about the piloting that is going on in the industry. The FDA will also establish some pilots under the DSCSA requirement. She looks forward to what we will learn over the next few years in their pilots and those by other stakeholders. She touched on the list they collected at the workshop of the myriad things that might be piloted by the FDA (see “The 2016 FDA Pilots Workshop” for that list).
She said, “We are moving forward on the pilot projects, that’s something we are focused on, but don’t worry, we are still working on all the other stuff that I haven’t even mentioned here. I know there are concerns about grandfathering, waivers and exemptions, we are working on all of that still. I haven’t shown on the slides when those things will come out but we are hoping to publish some of that information [soon].” (See “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”.)
Dr Jung pointed out that the FDA offers two email addresses to submit questions through, but they do not answer every question because they need to have clarity on their own interpretation of certain pieces of the law before they can respond to some questions, and that takes time. They will also not provide individual assessments of your special situations, but they still encourage you to submit them because it helps them understand the many issues the law raises.
The two email addresses for contacting the FDA with DSCSA-related inquiries are:
- WDD3PLRequirements@fda.hhs.gov for inquiries related to wholesale distributor and third-party logistics provider requirements;
- email@example.com for all other DSCSA inquiries.
Responding to questions raised by people in the audience, Dr. Jung stated that the FDA is aware of the issue regarding abbreviating the Transaction Statement (TS) (see “DSCSA: Transaction Statement”) but they have not issued any guidance on it. She thinks people have figured it out a certain way and the FDA will let them know through guidance if they think it should be done otherwise.
Regarding the disparity between wholesale distributor requirements to sell drugs only that contain the DSCSA Product Identifier (see “The DSCSA Product Identifier On Drug Packages”) and the similar dispenser requirement a year later to only buy drugs with that identifier, Dr. Jung said that they are aware of several places where one trading partner has to do something but the next trading partner’s requirement doesn’t exactly match up. She said that the FDA might need to provide more guidance on those things.
Regarding the volume of reports of illegitimate product received by the FDA since January 2015 up to now, Dr. Jung said that she did not have exact numbers, but they have received more than ten reports so far. There are several companies waiting to hear back from them, but some appear to not fall under the DSCSA requirements. They are still working on getting a solid ruling on that. Internally, they have to make sure they are following what they are allowed to do administratively under the statute and it has taken some time to get those internal processes in order. The final suspect product and notification guidance should provide some additional guidance to help companies report only what is necessary. They have definitely received notifications that are cases of “over-reporting”.
Regarding whether or not the FDA has seen any slowdown in the accessibility to medicines since the start of the lot-based requirements in January 2015, Dr. Jung responded, “Broadly no. …I can say we have been excited when we’ve been able to use some of the authorities under the DSCSA to investigate certain situations so it has come in handy.”
Regarding the exemption of blood factor, Dr. Jung said that she thought in the DSCSA definition of “product” there is an exemption for blood or blood components “intended for transfusion”, and to the extent that blood factor does not fall into that category, it appears it would not fall under that exemption (see also “Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?”).
Immediately after the session concluded I had to rush to catch my flight home. As I was compiling my notes I was struck by the fact that no one in the room—myself included—asked the obvious question of what we should expect to see next in the FDA pilots process? Will we see a Request For Proposal (RFP) from the FDA for prospective pilot participants to provide their offers to contribute to pilots with certain characteristics that they wish to be a part of? Will we see the FDA publish specifications for specific pilot(s) that they will define? And when will we see the next step? Even if we would have thought to ask these questions, I assume we wouldn’t have received a usable answer. We’ll just have to wait and see what actually happens next. It seems like the FDA is going to have a busy summer…or fall.