Storm brewing as pharma body asks FDA to nix DSCSA guide

The Healthcare Distribution Alliance has asked the FDA to withdraw recently-issued draft guidance on the implementation of a track-and-trace system for medicines in the US supply chain.

The HDA – which represents pharma distributors – has made the request in a lengthy comment to the US regulator on the Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (EDDS) guidance, which was published in draft form in June.

It has "serious concerns" about the guidance, which covers elements including data architecture, incorporation of the product ID into tracing information, and enhanced verification of distributed and saleable returned products as well as alerts for illegitimate packs.

As it stands, the EDDS document doesn’t "clearly articulate" the essential requirements needed for compliance with the DSCSA, which requires a full track-and-trace system for medicines distributed in the US market to be in place within 10 years – by November 27, 2023, according to the current implementation timeframe.

The HDA also claims that the guidance is inconsistent with the requirements set forth in the DSCSA as well as "compliance characteristics that the supply chain has been implementing for years and has shared with the agency on numerous occasions."

"For the first time in guidance, FDA describes a 'system' that, we believe, is fundamentally counter to the plain language of the DSCSA and, as such, is not what industry has collectively spent the last seven years investing in and building," it goes on.

The system laid out in the EDDS "does not exist, is not required by the statute, and, in our considered judgement, cannot be built in time to meet the 2023 deadlines even if it were statutorily mandated," according to the trade body.

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It also "poses unacceptable security and compliance risks," for example by requiring trading partners to open up proprietary systems for a direct connection with government or other trading partners, and is "in excess of agency authority."

The commentary – a full 37 pages – comes during a 30-day extension to the comment period requested by the HDA and Pharmaceutical Distribution Security Alliance (PDSA), yet nevertheless only focuses on the main points of contention with the document.

It focuses in particular on the following:

-         Aggregation and inference

-         Reconciliation and discrepancies

-         Verification

-         Validation

-         Integration

-         Alerts

"We urge its immediate withdrawal as it predominately sets out an 'enhanced system' that is not what Congress intended or enacted in the DSCSA," according to HDA senior vice president of regulatory affairs Anita Ducca.

The HDA also soughtmore time to review another draft guidance entitled Definitions of Suspect Product and Illegitimate Product for Verification Obligations (definitions guidance), but the FDA has not budged on its timeline for that document.