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Following a November FDA public meeting, HDA reiterates the objections it had to guidance FDA issued in mid-2021 under the Drug Supply Chain Security Act (DSCSA)
The news is that there is no news from FDA about revising a proposed guidance on the so-called enhanced drug distribution security (EDDS) format that was issued last summer. The Healthcare Distribution Alliance (HDA) stiffly rejected much of the guidance and had recommended withdrawing it altogether in August. FDA held a public meeting in mid-November but its statements look, to HDA, as if it is plowing ahead. Now, HDA has issued another response in mid-January, reiterating its objections. The clock is ticking on a November 2023 deadline, when a fully DSCSA-compliant track-and-trace system with EDDS comes in place, covering transactions from the manufacturer, to the pharmacy and any intermediaries between the two.
HDA has numerous objections to how EDDS is being presented by FDA (the latest letter runs 18 pages), but the one key is FDA language in the guidance that implies a “system” will be in place by which FDA (or other regulators) can zoom across distribution channels to collect transaction data. HDA points out that the industry (manufacturers, wholesalers, pharmacies and various contractor organizations) is moving toward a decentralized system, where transaction data is stored among selected trading partners. Retrieval of it will be possible, but not as a near-real time electronic search.
Even getting this decentralized arrangement up and running is problematic; many organizations (especially within the pharmacy community) are slow to get onboard—and the pandemic has retarded everyone’s efforts. Says the letter: “[A]ny guidance that fundamentally differs from what industry has adopted and implemented is likely to cause even greater consternation and delay. Any further divergence or distractions will imperil the industry’s ability to meet 2023 requirements at all…”
Thus, industry is struggling to adapt an approach that, in the end, might not comply with what FDA would require, and this dispute is slowing down the overall compliance effort. The most likely scenario (and one that FDA is emphatically not encouraging) will be a delay in the compliance deadline, along with litigation if FDA’s official stance on technical details does not change.