New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability

By Carl Accettura, Global Pharma Advisory

Pharmaceutical manufacturers should immediately assess their strategies for the next five months to achieve DSCSA compliance ahead of the looming Nov. 27 deadline. At a June meeting, FDA officials announced that we can’t kick the can any further down the road. Industry must be ready to exchange electronic EPCIS interoperable data between authorized trading partners (ATPs).

This is the moment we’ve been waiting for: FDA is ending its yearlong enforcement discretion and expects companies to be compliant. Companies can be subject to FDA enforcement actions on Nov. 28, and no one wants to become the poster child for noncompliance.

While each company should have in-house, cross-functional initiatives between their internal departments — supply chain, regulatory, and quality — DSCSA enhanced drug distribution security (EDDS)¹ compliance by your organization still requires external collaboration, coordination, and data exchange testing with your ATPs (e.g., Cencora, Cardinal, McKesson, etc.) and solution providers (e.g., TraceLink, Systech, rfXcel, etc.).

Meanwhile, FDA provided an option for those companies that will not be fully compliant in time: the waivers, exceptions, and exemptions program (WEE).² FDA recommends trading partners submit a waiver or an exemption request by Aug. 1, 2024. This, of course, is not a simple solution and is fraught with compliance risks. FDA can’t guarantee it will grant or deny the waiver or exemption by Nov. 27. If there is a large wave of requests, FDA may be unable to react in time and leave you hanging, in a state of admitted non-compliance.

Equally critical is the significant business risk of lost sales if your product is quarantined at your wholesaler’s warehouse. Thus, your cross-functional supply chain/regulatory/quality team should obtain legal and regulatory advice and make recommendations to company management since FDA will not pause or extend the compliance requirements upon submission of a WEE request or while FDA’s response is pending. Meanwhile, FDA expects trading partners to continue their efforts to meet requirements until FDA has approved or denied WEE requests. FDA expectations have risen, and there is no rest for the weary.

DSCSA Stabilization Period Midway Checkpoint: A Rude Awakening

FDA and the Partnership for DSCSA Governance (PDG) conducted a critical public meeting on June 17 and 18 in Washington, D.C.,³ as a checkpoint during the one-year stabilization period, which was announced last year. The PDG has a public-private partnership with FDA and has been instrumental in authoring a blueprint for industry to follow.⁴

The checkpoint was a rude awakening. The wholesalers reported far less than what’s needed for full stabilization, with manufacturers only in the range of 75% to 85% transmission of data. Factoring in the untested and uncorroborated data, the range of clean interoperable data sharing fully downstream was much lower, in the 50% to 60% range. Dispensers painted an even bleaker picture of operational readiness, and, by that point, FDA had already given up and issued a blanket exception for small dispensers.

Matt Price, PDG board member, gave opening remarks on day one and used the road trip analogy. The kids are saying, “Dad, are we there yet?” or, “How much farther do we have to go?”

I attended the meeting, and have a travel analogy of my own: “On this FDA road trip to DSCSA compliance, does anybody need a WEE break?"

Whether you apply for a WEE and get it or work toward compliance by the deadline, you must make a strategic assessment now for your company and chart a path forward. Delay at your own risk.

The Very Real Threat Of Counterfeits

Recent reports of Ozempic counterfeits⁵ build the case for immediate compliance to verify and trace products. The counterfeit boxes had the same serial number, 430834149057, on all packages. It took a third-party quality review of the product to spot them, which suggests a lack of quality systems and processes (SOPs) at the distributor who accepted the counterfeits and tried to sell them to unprepared doctors. As industry expert Tim Marsh noted in his blog post⁶ after the FDA meeting:

“This is no small problem. One pharma colleague bravely commented on this as a real issue. Duplicate serialized products appearing within a supply chain is one of the primary methods of identifying fake products. The primary reason serialized product identifiers are required by DSCSA is based on the premise that if you observe a duplicate there’s a strong possibility it is a counterfeit. Full stop!”

Does A WEE Request Put An Inadvertent Target On Your Back?

FDA has reinforced its authority to grant waivers, exceptions, and exemptions from certain requirements in section 582 of the Food, Drug, and Cosmetic Act (FD&C Act) as appropriate.⁷ An ATP or interested party may request a WEE from certain requirements⁸ related to product tracing and product identifiers. Verification in section 582 applies to trading partners as defined in section 581(23)(A) of the FD&C Act and includes drug manufacturers, repackagers, wholesale distributors, and dispensers (primarily pharmacies).

Expecting that some won’t reach 100% compliance by November, FDA extended another olive branch to industry by proposing a remedy via the WEE. However, this is fraught with compliance risks, since the requesting company effectively reveals its unpreparedness and puts an enforcement target on its back for 2025.

You’ll need an implementation plan before you request a WEE from DSCSA EDDS compliance. DSCSA plans require time, resources, collaboration, and coordination with your ATPs and the solution provider that has your DSCSA data repository and transfers your EPCIS shipment events to downstream ATPs.

Systems And Processes For DSCSA

Pharmaceutical manufacturers could be subject to inquiries/audits from both FDA and state boards of pharmacy regarding their DSCSA systems and processes.

Your cross-functional DSCSA supply chain/regulatory/quality team should read through the relevant PDG Blueprint and the HDA Exceptions Handling Guidelines to ensure your systems and processes (SOPs) are audit-ready, including verification and tracing for suspect or illegitimate product. Per FD&C Act Section 581 (27)(E),⁹ every company, when transmitting each shipment event data file, makes the transaction statement (TS) attestation that it has the systems and processes in place to comply with the verification requirements under section 582.  

Manufacturers have no more than 24 hours to respond to an ATP’s request to verify a package-level serial number. Manufacturers need SOPs for ensuring any such request is vetted for authenticity.

The PDG Blueprint gets specific in Chapter 4: Product Identifier Verification Functional Design,¹⁰ which provides detailed information on how electronic PI verification functional components of the PDG-defined DSCSA EDDS network operate.

HDA DSCSA Exceptions Handling Guidelines

As the supply chain moves toward Nov. 27 compliance, the mandatory interoperable exchange of serialized data adds significant complexity to sector operations. There will be instances of data and product mismatch. The scenarios covered within the Healthcare Distribution Alliance (HDA) Exceptions Handling Guidelines document¹¹ focus on transactions between manufacturers and distributors and fall within five categories:

• Data issue
• Product, but no data
• Data, but no product
• Packaging and labeling
• Unavailable for distribution

Prepared by technical experts of the HDA Exceptions Handling Work Group, these guidelines were developed to address exceptions that may arise when passing or failing to pass DSCSA-required transaction information and transaction statement data to ATPs.

Pharmaceutical manufacturers should become familiar with the PDG Blueprint and HDA DSCSA Exceptions Handling Guidelines to assess their readiness and translate DSCSA compliance into robust SOPs.

References:

1. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act and https://www.fda.gov/media/164084/download
2. https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/waivers-and-exemptions-beyond-stabilization-period
3. https://www.fda.gov/news-events/partnership-dscsa-governance-pdgfda-joint-public-meeting-dscsa-stabilization-period-midway
4. https://dscsagovernance.org/blueprint/
5. https://www.vanityfair.com/news/story/counterfeit-ozempic-global-growth-industry
6. https://medium.com/@marsavius/musings-of-a-secret-squirrel-the-state-of-dscsa-readiness-mid-2024-66a4cbcc943a
7. https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-dscsa-waivers-exceptions-and-exemptions
8. https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/drug-supply-chain-security-act-product-tracing-requirements-frequently-asked-questions
9. https://www.fda.gov/drugs/drug-supply-chain-security-act-dscsa/title-ii-drug-quality-and-security-act
10. https://dscsagovernance.org/wp-content/uploads/2023/09/Fact-Sheet-Interoperable-Verification.pdf
11. https://www.hda.org/publications/exceptions-handling-guidelines-for-the-dscsa-2023/

About The Author:

Carl Accettura is a 40-year veteran of FDA-regulated operations with diversified global experience in both large and small pharmaceutical manufacturers. He has made senior-management-level contributions in the areas of global supply chain management, global drug development and commercialization, across numerous therapeutics and new Rx product launches. He holds a B.S. degree in mechanical engineering from Cornell University, an M.Sc. degree in mechanical engineering from the University of Illinois, and an MBA from New York University.