When it comes to the Drug Supply Chain Security Act (DSCSA), the FDA seems to alternate between hibernating, and leaping forward. 2017 through mid-2018 was a leap forward period with the publication of 8 draft or final guidance documents and 3 public meetings. Then in 2019, hibernation. Yes, FDA’s list of DSCSA guidance and policy documents has two entries for 2019 so far, but one is simply a notice reopening the comment period on the DSCSA Pilots request for information that was originally opened in 2016 and 2017. The other is the compliance policy that provides one year of enforcement discretion for the 2019 wholesaler saleable returns requirement (see “No Surprise: DSCSA Verification Delay”). Neither were very taxing on the FDA to prepare. What should the FDA do next? What should they be doing right now?
If the DSCSA Enhanced Drug Distribution Security (EDDS) phase is going to start on time on November 27, 2023, FDA will have to come out of hibernation mode soon and hit the ground running for the next three years straight (see “EDDS: The New Data Exchange Requirements”). What are the odds of that happening? I’ve already mentioned the coming milestones included in the DSCSA for the FDA between now and 2023 (see “DSCSA Schedule Assessment, July 2019”), but let’s take a closer look at the details of those milestones and what the FDA will need to do to accomplish them.
1. Conduct at least 5 public meetings (Section 582[i], due July 1, 2021)
The DSCSA requires the FDA to conduct five public meetings “…to enhance the safety and security of the pharmaceutical distribution supply chain and provide for comment”. But the requirement isn’t that simple. The DSCSA assigns specific topics that must be covered in at least one of these five meetings. Under Section 582(i)(2), these include:
“(A) An assessment of the steps taken under subsections (b) [Manufacturer requirements] through (e) [Repackager requirements] to build capacity for a unit-level system, including the impact of the requirements of such subsections on—
- “(i) the ability of the health care system collectively to maintain patient access to medicines;
- “(ii) the scalability of such requirements, including as it relates to product lines; and
- “(iii) the capability of different sectors and subsectors, including both large and small businesses, to affix and utilize the product identifier.
“(B) The system attributes necessary to support the requirements set forth under subsection (g) [establishment of the EDDS requirements], including the standards necessary for adoption in order to support the secure, interoperable electronic data exchange among sectors within the pharmaceutical distribution supply chain.
“(C) Best practices in each of the different sectors within the pharmaceutical distribution supply chain to implement the requirements of this section.
“(D) The costs and benefits of the implementation of this section, including the impact on each pharmaceutical distribution supply chain sector and on public health.
“(E) Whether electronic tracing requirements, including tracing of product at the package level, are feasible, cost effective, and needed to protect the public health.
“(F) The systems and processes needed to utilize the product identifiers to enhance tracing of product at the package level, including allowing for verification, aggregation, and inference, as necessary.
“(G) The technical capabilities and legal authorities, if any, needed to establish an interoperable, electronic system that provides for tracing of product at the package level.
“(H) The impact that such additional requirements would have on patient safety, the drug supply, cost and regulatory burden, and timely patient access to prescription drugs.
“(I) Other topics, as determined appropriate by the Secretary.”
I think you could assume that at least some of these topics have been touched on in the three DSCSA public meetings the FDA held in the second half of 2017 and the first quarter of 2018 (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”, “FDA DSCSA Public Meeting #2, Still A Gulf” and “FDA DSCSA Public Meeting #3: A Difference?”). If you stretch your imagination, maybe a few more were touched on, but some have definitely not come up, including D, E, F, G and H. So we should expect at least two more public meetings that at least touch on these topics.
Two more meetings would fulfill the statutory requirement, but in my view, it is going to take a lot more than that to align the FDA and the industry on these topics, especially given the lag between the first two and whatever comes next. Anyway, if 2020 doesn’t become the year of the critical FDA DSCSA public meetings—and by that I mean at least six more public meetings spaced every two months through the year—it will be impossible to answer the questions and resolve the issues we face by November 2023, the effective date of the EDDS.
2. Establish 1 or more pilot projects in coordination with stakeholders to explore and evaluate methods to enhance the safety and security of the supply chain (Section 582[j], due January 1, 2021)
FDA can check this requirement off as soon as they publish their promised “final program report” when the program concludes. In the next few months we will see how much value the pilot program contributes toward establishing a common path toward interoperability for meeting the 2023 requirements. If the FDA just treats it like a checkbox and not as a way of sorting through various approaches and then narrowing that list, it could end up contributing negative value. I’m hoping they do the latter.
3. Conduct and complete a technology software assessment on feasibility of small dispensers to conduct drug tracing at the package level (Section 582[g][A], due January 1, 2021)
I haven’t seen any movement toward meeting this requirement. I think the first thing we would see is an RFQ/RFI for, what the DSCSA calls, “…a private, independent consulting firm with expertise to conduct a technology and software assessment…” to look into “…the feasibility of dispensers with 25 or fewer full-time employees conducting interoperable, electronic tracing of products at the package level.” That assessment will take some time so if the FDA is on top of this requirement, we should see the RFQ/RFI very shortly. There is just enough time to conduct this assessment before the due date set by Congress.
4. Publish final guidance on system attributes necessary to enable secure tracing at the package level (Section 582[h], due November 27, 2022)
The deadline specified in the text of the DSCSA for this final guidance document is “…not later than 18 months after conducting a public meeting on the system attributes necessary to enable secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary…”, but the FDA has set the goal of November 27, 2022 for themselves. If these two deadline interpretations are to align, then the public meeting on system attributes would have to occur around May 2021 but I think these should be viewed as that latest possible dates and both events (the meeting and the publication of final guidance) should occur at least a year earlier to give the industry time to implement the final guidance.
If the FDA doesn’t accelerate these dates then they will be forced to implement enforcement discretion for the November 2023 final date. It’s as simple as that. Hey FDA, let’s have this public meeting by the end of May 2020 so we can start making the necessary system and process changes. Watch the actual timing of this critical milestone.
5. Publish final guidance on the standards for interoperable data exchange to enhance secure tracing of product at the package level (Section 582[h], FDA says this is due November 27, 2022)
Again, the FDA has set their own deadline for the publication of this final guidance, but like the system attributes guidance above, the text of the DSCSA says the deadline is “…not later than 18 months after conducting a public meeting on the interoperable standards necessary to enhance the security of the pharmaceutical distribution supply chain…”. Likewise, the FDA should accelerate both the public meeting specified and the publication of the final guidance.
Note that the deadline for the draft guidance for the standards for interoperable data exchange was way back in 2014 (Section 582[a]). That’s right, we already have the draft guidance for this topic (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”). The DSCSA gives the FDA quite a few years to study the issue and learn what is really necessary for interoperable data exchange before they must finalize the guidance. Again, watch the actual timing of this critical milestone.
6. Develop regulations establishing an enhanced drug distribution security system for interoperable electronic tracing of product at the package level (Section 582[g], due November 27, 2021)
This is the big milestone. No one can begin planning or implementing a solution for the EDDS until these regulations a published in final form. The text of the DSCSA says they have to be published two years before the effective date of the EDDS, November 27, 2023. That means the FDA has two years to get there. It’s crazy to expect these regulations to be published by November 2021 but then not have the final guidances on standards and system attributes for enhanced secure tracing of product at the package level a year later. That doesn’t really work. I think a realistic sequence would be just the opposite—only with earlier deadlines to maximize the time for implementation, testing and getting everything switched over to the new systems and processes.
The timing of these later milestones are unrealistic in the DSCSA and no matter how you rearrange them to make them more logical, there just isn’t enough time to get everything done between what the FDA needs to do and what the industry will face once the FDA is done. That’s especially true when you consider the slow progress of the FDA on meeting their deadlines (see “DSCSA Schedule Assessment, July 2019”).
Things are going to get more exciting very soon now that we are approaching the anniversary date of the DSCSA being enacted in 2013. That date will mark the three year point to the effective data of the EDDS. So much has to happen before that date will be workable for the industry. Most of what has to happen next is on the FDA, not the industry, but their time will come. Will 2020 be FDA’s year to leap forward? Based on this closer look, it has to be.
Stay tuned. There is more to think about on this topic.