Last Friday was the deadline for the FDA to publish four new guidance documents under the Drug Supply Chain Security Act (DSCSA) (see “Decoding The FDA’s DSCSA Timeline”). The deadline was established by the U.S. Congress when they enacted the legislation and it was signed by President Obama on November 27, 2013 (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). But time spent by the FDA to meet their obligations under the DSCSA is “unfunded”. That is, Congress did not provide any specific additional money to pay for the FDA’s new obligations under the DSCSA. It is an unfunded mandate.
Fortunately the FDA is able to submit an estimated budget proposal every year to justify to the Congressional Appropriations Committees its overall funding. For Fiscal Year 2016, the FDA’s justification included several mentions of ongoing work to implement the DSCSA. But because the FDA’s annual budget is so huge, and the costs of creating a few guidance documents is comparatively miniscule, there is no line-item that covers just the DSCSA work. I suspect this will be true through at least 2021, but after that the FDA may need to raise additional funds to offset the agency costs of implementing the “Enhanced Drug Distribution Security” (EDDS) phase of the DSCSA that is due to start on November 27, 2023. Will a new User Fee Act (UFA) make sense at that time (see “Would A U.S. Federal Pedigree Law Require A New UFA?”)? Maybe.
Right now we know that the FDA is preparing to establish at least one pilot project in the near future because in early August it posted a Request For Proposal (RFP) for a consulting organization to help it establish a program of pilot projects without a UFA (see “FDA Looking For Consulting Org To Run DSCSA Pilots”). But these pilots appear to be aimed at meeting the DSCSA requirement to run at least one pilot project with industry stakeholders and are not related to the missing guidance documents.
The overdue guidance documents include:
- Regulations establishing standards for licensing of third-party logistics providers [DSCSA Section 584(d)(1)];
- Regulations establishing standards for licensing of wholesale drug distributors [DSCSA Section 583(a)];
- Guidelines on processes for waivers, exceptions and exemptions to the DSCSA [DSCSA Section 582(a)(3)];
- Final guidance on grandfathering product [DSCSA Section 582(a)(5)(A)].
Once these documents are published, it will effectively double the number of FDA guidance documents related to the DSCSA (see “FDA’s DSCSA Guidance in 2014”), if you ignore the two that simply announce enforcement discretion for two compliance deadlines (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”, “FDA Publishes New Guidance Delaying Dispenser 3T Requirements Until November 1, 2015” and “FDA Extends Dispenser Delay in DSCSA Enforcement”).
This same situation occurred last year when three new guidance documents we were due on November 27, 2014. One came out on November 28th and the other two were combined into one document and published on December 9, 2014, so if this year is like last year, we shouldn’t have long to wait. Obviously, the FDA has a lot on its plate and meeting this kind of deadline is not a drop-dead priority. I’m willing to give them a pass…for a while anyway.
It is interesting that, earlier this year, the FDA actually listed six DSCSA-related documents that it thought it would publish in 2015. In their annual “Guidance Agenda”, revised on April 28, 2015, the agency included the following DSCSA guidance documents:
- DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third Party Logistics Providers
- DSCSA Implementation: Products Eligible for Grandfather Status
- DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices
- DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs
- DSCSA: Verification Systems for Prescription Drugs
- DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements
I can tell you that a listing in this Guidance Agenda is certainly no guarantee. I have watched it in the past and have seen several track and trace related documents listed that have never been published, even years later (see also “FDA DSCSA Deliverables Are Bunching Up In Second Half of 2015”). I was hoping we would see at least some of mandated documents last week. Maybe this week. I’ll let you know when they arrive, and then I will give you my analysis of each one.