Happy New Year, 2018 is here! Last year, the FDA announced a series of three Drug Supply Chain Security Act (DSCSA) Public Meetings (see “FDA Announces New DSCSA Pilot Program and Public Meeting Series”). So far they have held two (see “FDA DSCSA Public Meeting #1 Exposes Gulf In Goals” and “FDA DSCSA Public Meeting #2, Still A Gulf”). One more is left in that series, to be held on February 28, 2018. According to the FDA website, registration will open today for that third meeting. Make sure you register early because seating is usually limited. The meetings are usually partially webcast if you can’t make it.
This time the topics will be:
- Further refinement of enhanced drug distribution security needs
- Building capacity for a unit-level system
Will this be the last DSCSA public meeting held by the FDA? Certainly not. I expect them to announce a new series of meetings shortly after this next one is held. How do I know? Here’s how…
The FDA is bound by the contents of the DSCSA almost as much as companies in the supply chain are. The only difference is, unlike you, there is no one out there who enforces their requirements (see “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?”).
BUT WHO’S COUNTING?
The DSCSA actually lists a number of topics that the FDA must include in one of at least five public meetings they are required to hold. These meetings were required by Congress to ensure that the industry is able to make their ideas and opinions known to the FDA before they “…enhance the safety and security of the pharmaceutical distribution supply chain…”. Section 582(i)(2) lists the following topics that must be covered in these meetings:
“(A) An assessment of the steps taken under subsections (b) [manufacturer requirements] through (e) [dispenser 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) [the 2023-specific 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.”
It appears that part of the first topic, (A), will be covered in the next meeting (“building capacity…”). I think the topics listed in (B), (F), and maybe (G) were probably covered in the December meeting. If that’s true, then the date of that meeting started the clock on the FDA issuing a final guidance on the exchange of transaction information and the transaction statements in a secure, interoperable, electronic manner as part of the Enhanced Drug Distribution Security (EDDS) phase that begins on November, 27, 2023. According to Section 582(h)(3) they are required to publish that final guidance within 18 months of holding that public meeting. So watch for that guidance by June 4th, 2019.
Topics (C), (D), (E), (H) and maybe (G) have apparently not been covered yet. That is what gives me the confidence to believe they will announce another set of public meetings as soon as this series is complete. How many there will be is hard to say, but 2018 will be the year for public meetings, so some decisions can be made by the FDA and by the industry in the years after that (see “A US Medicines Verification Organization (USMVO)? Again”). Now is the time to make your opinions and ideas known. In addition to these meetings, you can submit written comments to the docket associated with the meetings. Use Docket No. FDA-2017-N-3857 and submit at http://www.regulations.gov.
See you there!
Dirk.
