Many RxTrace readers probably saw the FDA press release last week that included the timeline chart called “Summary of Planned Implementation Timeframes for the Drug Supply Chain Security Act”. If you did not see it, here is the link. I found the text to be too small so I reproduced the chart using a larger font size. See that version below. Click on it to enlarge the image. You might find this version better for inclusion in Powerpoint slides.
This is the FDA’s interpretation of their obligations under the Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA) that was signed into law last November (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). There really are not any surprises in their interpretation, but there are a few interesting things to notice in this timeline and the associated table of target dates that accompanied it. I have also reproduced the FDA’s deliverable table, but my version is sorted by the estimated target date column to make it easier to see what they plan to do in time sequence.
The first thing to notice about the timeline is that the FDA does not plan to hold any public meetings this year.
Why is that? You might think the FDA would want to at least collect ideas about the standards for the interoperable exchange of transaction data in a public meeting, since they are required to publish draft guidance on those standards by November 27. Well, there is a reason that there are no public meetings until next year. Take a look at Section 582(i), “Public Meetings” of the Food Drug and Cosmetics Act (as modified by Section 203, “Enhanced Drug Distribution Security” of the DSCSA). Paragraph (1) says, in part:
“(1) IN GENERAL.—The Secretary shall hold not less than 5 public meetings to enhance the safety and security of the pharmaceutical distribution supply chain and provide for comment. The Secretary may hold the first such public meeting not earlier than 1 year after the date of enactment of the Drug Supply Chain Security Act…”
The FDA may hold the first public meeting no earlier than November 27, 2014. That is, Congress specifically bars them from holding a meeting related to the DSCSA until after that date. Of course, then you have the holidays to avoid, so the FDA has decided their first meeting will occur after the new year.
The reason Congress many have done this is that it gives the FDA the ability to publish those draft standards with less in their way. No meetings to schedule, consolidate the results, then write guidance based on all that. The public can still submit comments about those standards through the docket that the FDA recently published notice of in the Federal Register (see “DQSA: How Should Transaction Data Be Exchanged?”). It will be only draft guidance, after all, with the final guidance coming years later—sometime between January 2018 and November 2022, according to the FDA timeline. (text continues below table)
|Section of DSCSA||Deliverable Type||Deliverable Description||Estimated Target Date|
|202||FR Notice||Issue notice of public docket to collect stakeholder comments on standards for interoperable exchange of transaction information/history/statement in paper or electronic format||2/20/2014|
|203||Guidance||Publish guidance on identification of suspect product and termination of notifications of illegitimate product for finished human prescription drugs||5/26/2014|
|202||Guidance||Publish draft guidance establishing standards for interoperable exchange of transaction information/history/statement in paper or electronic format||11/27/2014|
|205||Database||Establish a system for third-party logistic provider reporting to FDA||11/27/2014|
|204||Database||Establish a system for wholesale drug distributor reporting to FDA and public database with licensing information||1/1/2015|
|202||Guidance||Publish guidance on processes for waivers, exceptions, exemptions||11/27/2015|
|202||Guidance||Publish final guidance on grandfathering product||11/27/2015|
|204||Regulation||Develop regulations establishing standards for licensing of wholesale drug distributors||11/27/2015|
|205||Regulation||Develop regulations establishing standards for licensing of third-party logistic providers||11/27/2015|
|203||Regulation||Develop regulations establishing enhanced drug distribution security system for interoperable electronic tracing of product at the package level||11/27/2021|
|203||Guidance||Publish final guidance on system attributes necessary to enable secure tracing at the package level||11/27/2022|
|203||Guidance||Publish final guidance on standards for interoperable data exchange to enhance secure tracing of product at the package level||11/27/2022|
|203||Assessment||Conduct and complete a technology and software assessment on feasibility of small dispensers to conduct drug tracing at the package level||TBD|
|203||Public Meeting||Conduct at least 5 public meetings||TBD|
|203||Pilot Project||Establish 1 or more pilot projects in coordination with stakeholders to explore and evaluate methods to enhance the safety and security of supply chain||TBD|
The next DSCSA-related thing we can expect from the FDA is the publication of guidance on identification of suspect product and termination of notifications of illegitimate product for finished human prescription drugs, which should be done by the end of May, according to the table of deliverables. Then, we don’t expect anything until November, when the FDA will publish the draft guidance we discussed above and will have a database of third-party logistics providers online.
Next year will be a big year for FDA deliverables, but then things go slack until 2021. But this will be the time that the FDA is conducting those minimum of 5 public meetings and 1 industry pilot, so “slack” is not really the right word for it. According to the chart, the FDA has until mid-2021 to complete the public meetings and until the end of 2020 to complete the pilot. And, of course, these are only minimums established by the law. The number of specific topics that must be covered in the public meetings are also dictated by Congress within the DSCSA, and if the FDA finds that they cannot reasonable cover multiple topics per meeting, then there could be more meetings.
There is a lot to do, but in my opinion, the FDA’s first priority should be something that is not on this chart or table. They need to hire more staff who have backgrounds in supply chain operation and security. The DSCSA allows the FDA to collect reasonable fees for the costs associated with establishing and administering the new wholesale distributor and third-party logistics provider licensing programs, including inspections. This is a new user fee, and it appears that the FDA will need to get authorization from Congress in an appropriations Act when raising these fees. A new User Fee Act (UFA)? That’s what it looks like to me. But those fees will probably not cover the cost of everything the DSCSA requires of the FDA so they will probably need to take existing money away from other allocations to make all this happen.
Can you extract anything else from these graph and table that is not obvious on first read? Leave a comment below.
2 thoughts on “Decoding The FDA’s DSCSA Timeline”
Thanks as always. The Unique Device Identifier UDI program established a marking system and the requirements for a database first. These are enablers for anything which follows. I believe that, similarly, the first steps in DQSA need to be establishing the labeling systems and database requirements.
Because a labeling system and tracking and tracing are wound up together in the DSCSA, who knows what the implementation plan really is?
The UDI approach allows industry to make use of systems and begin to take advantage of supply chain opportunities now that they know what those requirements are.
Awaiting your further insights.
We have to be careful not to draw too many similarities, or unrealistic expectations of the FDA, in comparing UDI to DQSA (so hard to shift to DSCSA).
UDI is to medical devices to what the NDC code is to drugs; a consistent identification of the product. The intent of UDI was to simply (I use that term loosely) to identify devices with a unique number, and have a database that stored information about those products. What it wasn’t ever intended to do was to create a unique record about each manufactured devices.
What the FDA has to do for the Pharma industry is significantly different that what they had to do with the device industry. It involves labeling, but it involves a significantly larger effort to realize the “Track & Trace” effort… and a single “database” probably isn’t the answer.
Creating a database to store static information about devices (<10k PMA or 510k/year) is a much easier putt than a designing a system to exchange data between multiple trading partners for a volume well into the Billions.
The other item to consider… It took UDI 4+ years to actually release a regulation, I was getting ready the UDI Regulation back in Dec '10… it didn't come to fruition until Jul '13.
Apples & Oranges
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