Last Wednesday the FDA held the third in a series of three Drug Supply Chain Security Act (DSCSA) public meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). I noticed a few important differences at this meeting compared with the two previous meetings (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals”, and “FDA DSCSA Public Meeting #2, Still A Gulf”).
Overall, these differences indicate that the FDA may be beginning to recognize how much ground they and the industry must cover between now and November of 2023, and it appears that has led them to get a little more rational. One meeting is not enough to establish a change in pattern, but if it eventually proves true, then this meeting would be the beginning of that change. A big injection of rationality is what happened in Brazil back in late 2016 (see “Brazil Gets Rational With Their New Pharma Traceability Law”) and that seems to have put them on a course for success. Could something similar be happening here?
FDA COMMISSIONER SPEAKS
The meeting started off with a short welcome and opening remarks by the FDA Commissioner, Dr. Scott Gottlieb, MD. When I saw Dr. Gottlieb on the agenda I figured he probably just happened to be scheduled in that building and had a few minutes open, so they slotted him in to tell us the state of healthcare in the US, or something mundane like that, and then he’d be shuttled out of the room so we could get down to business. I couldn’t have been more wrong. His comments clearly demonstrated a depth of knowledge of the DSCSA and the issues facing the industry that I wouldn’t expect to exist in the FDA higher than Dr. Ilisa Bernstein, Pharm.D., J.D., who is Deputy Director of FDA’s Center for Drug Evaluation and Research’s (CDER’s) Office of Compliance.
During a break I learned that the FDA Commissioner position is three reporting levels above the Deputy Director of CDER’s Office of Compliance (Dr. Bernstein’s position). I’ve been critical of the FDA in the past based on my perception of their inattention to the DSCSA, even going so far as to speculate that perhaps they were intentionally delaying publication of the overdue guidance documents (see “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?”). And I openly wondered if they have even a single full-time person assigned to work on the DSCSA (see “FDA Forfeits Opportunity To Guide Industry”). The fact that the FDA Commissioner is capable of intelligently discussing specific sections of the law at this level puts those theories to rest. I should be glad that so few FDA employees actually read RxTrace, or maybe they wouldn’t be so kind to me at these meetings! 😉
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If you weren’t present to hear Dr. Gottlieb’s comments, go read them now on the FDA website. You will eventually be able to listen to the webcast recording of the event here, excluding the breakout sessions.
Dr. Gottlieb announced the publication of two new guidance documents:
- Definitions of Suspect Product and Illegitimate Product For Verification Obligations Under the Drug Supply Chain Security Act (7 pages);
- Standardization of Data and Documentation Practices for Product Tracing (23 pages).
I will provide an overview of both of these important new guidance documents in one or more RxTrace essays in the next two weeks.
Perhaps more importantly, if you are a wholesale distributor or third-party logistics provider (3PL), Dr. Gottlieb also announced the FDA’s “…intent to update the agency’s interpretation of Section 585 of the FD&C Act, which contains express preemption provisions addressing both tracing and licensure.”
Section 585 of the FD&C was added by the DSCSA and has the title “UNIFORM NATIONAL POLICY”. It is the part of the DSCSA that preempts state governments from maintaining their own drug serialization and/or tracing regulations. Wholesale distributors and 3PLs have been plagued since the DSCSA was signed into law by inconsistent interpretation of this section by different states. This has resulted in state requirements that are literally impossible to fulfill for some legitimate members of the supply chain because the state is trying to regulate things that the DSCSA covers. Since 2014, when the FDA last attempted to clarify this section, the Healthcare Distribution Alliance (HDA) has been calling for the FDA to clarify this section, to relieve these companies from state overreach. It sounds like the FDA may have finally heard these concerns and intends to address them before the end of the year.
“After close consideration, we intend to take a hard look at addressing this concern. Fragmentation of state licensing regimes was one of the security vulnerabilities Congress sought to address in the law. We have heard your comments that a confusing, 50-state patchwork of requirements for wholesale and 3PL licensing would frustrate Congress’s intent; and leave vulnerabilities that would both increase costs for manufacturers and suppliers and complicate state and federal enforcement efforts. We plan to release new regulations that, when final, will apply to all state and federal licenses issued to wholesale distributors and 3PLs. We’re working to publish these regulations later this year.”
It’s not a small thing when the FDA Commissioner is able to speak that knowingly about the details of your regulation. So that’s the first difference I noticed.
FDA VISION DE-EMPHASIZED
The second difference over previous meetings was that the FDA seemed to drop all pretenses about exploring their “vision” of the drug distribution system in 2023 and beyond. In the previous two meetings they seemed to want to drive the industry to talk about ideas that go well beyond the requirements of the DSCSA, thus wasting everyone’s precious time (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “FDA DSCSA Public Meeting #2, Still A Gulf”). And I’m not the only person who feel that way (see “HDA Schools FDA On DSCSA”). There is too little time left now to talk about anything except what everyone needs to figure out and do to meet just the basic requirements. In this meeting, the FDA seemed to have gotten the message. They mentioned their vision, but did not spend any time pushing ideas beyond the DSCSA.
The specified topics assigned to this meeting in advance of it included:
- Further refinement of enhanced drug distribution security needs
- Building capacity for a unit-level system
Interestingly, the topics actually discussed were a little different. They were:
- Enhanced drug distribution security needs
This amounted to a full group discussion with the FDA displaying the list that they had previously constructed from the two earlier meetings, and asking if anything on the list was wrong or missing. A few suggestions were thrown out by the audience at random, with the FDA staff taking notes and only asking questions when they needed to clarify the point made by the audience member.
- FDA protection of confidential commercial information and trade secrets
This was a brief formal presentation by Howard Philips of the FDA explaining FDA’s handling of Freedom of Information Act (FOIA) requests so that they protect confidential information. It seemed a little disconnected from the purpose of the meeting, but at least it was a short diversion.
- Verification using the product identifier
This was a breakout session where attendees were broken into separate groups based on their role in the supply chain: manufacturers, wholesale distributors and dispensers. Each group was sent to a separate room to answer a set of questions about verification from that segment’s perspective. Interestingly, the group dialog at the report-out revealed differences in interpretation of the DSCSA verification requirements. Some manufacturers interpret the law to require them to respond to any request for verification, because some requests might be necessary from companies they do not have a direct sales relationship with. Other manufacturers refuse to honor requests for verification today for anyone they do not sell products to directly, which means that most requests from pharmacies are rejected. Those rejected are instructed to make the request to their immediate supplier instead.
- Guardrails identification and prioritization
This was also a breakout session, but attendees were grouped randomly and everyone stayed in the same room. The FDA just wanted each group to create a list of “guardrails” that they think the FDA should offer, and then prioritize the list. The word “guardrails” was first introduced into the FDA DSCSA public meeting lexicon by an attendee at one of the previous meetings during one of the “open mic” sessions, and it stuck. My own interpretation of what the term means is “guidelines”, as in “We need guardrails (read: ‘guidelines’) around aggregation and inference”. Some of the things on the list could end up in formalized FDA guidance documents, but most may not elevate to that level. The problem is that there isn’t any way for the FDA to provide guidelines without publishing a formal guidance document, which takes a lot of effort. Some proposed that the FDA create an FAQ document similar to what the European Commission does for the Falsified Medicines Directive (FMD) (see “The Most Head-Scratching Section Of The FMD”) for this type of guideline. Odds are low that will ever happen, but it is a reasonable way to explain these types of “guardrails”.
I recently predicted that the FDA would likely announce another series of DSCSA public meetings during this one, but they did not (see “2018: The Year of FDA DSCSA Public Meetings”). In the closing, Dr. Bernstein acknowledged the differences in interpretation across sectors of the verification requirements and suggested that they may want to “flush that out” a little bit more among stakeholders. She said that the FDA will carefully review the information they have received through the dockets and the meetings. That amounts to a lot of information that they need to absorb and understand. She said that understanding will be very helpful as they move into the meetings that are specifically required by the law. So she apparently doesn’t count any of these three recent meetings as fulfilling any of those meetings, unlike my assumption earlier this year (see “EDDS: The New Data Exchange Requirements”).
Dr. Bernstein said that once they can wrap their arms around the information they have collected they will develop a plan for moving forward. That includes how they will establish requirements and issue guidance and guardrails that are needed. She encouraged everyone to “stay tuned for that”. With that, she thanked everyone for coming and encouraged everyone to continue submitting comments to the dockets that are open.
As I said, I noticed differences in this meeting compared with the two previous meetings. The attitude of the FDA representatives in the room felt different than the two previous meetings. They seemed to recognize that the amount of work that stands between where we are today as an industry, and where we need to go before we get to the Enhanced Drug Distribution Security (EDDS) phase, is huge, and the clock is not on our side. But was that a real change, or was it just something that came from “public meeting fatigue”? I hope it’s real, but we won’t be sure until the next public meeting. We’ll get a clue when we see how long it takes the FDA to announce the schedule of the next series of meetings. Until then, we can only hope.