Lawmakers, concerned about shortages, urge FDA to assess DSCSA readiness

Members of Congress are urging the US Food and Drug Administration (FDA) to assess the readiness of manufacturers in implementing the serialization systems called for in the Drug Supply Chain Security Act (DSCSA) before the 27 November 2023 deadline, asserting that drug shortages could result if manufacturers do not have these systems in place.

This call was made in a 1 August letter to FDA Commissioner Robert Califf by Reps. Troy Balderson (R-OH) and Ann Kuster (D-NH) and co-signed by 29 House legislators.

In a press statement, Balderson said some supply chain participants “are facing difficulties meeting DSCSA’s full implementation requirements … absent government intervention, there will likely be disruptions that could lead to patient access problems and further drug shortages.”

While Congress intended for the law to be fully implemented this year, the letter raised the issue that “if the supply chain is unable to fully implement the DSCSA by November 27, will FDA issue guidance within the next 30 days on enforcement policies for certain DSCSA requirements?”

Legislators suggested that FDA consider a phased approach to implementing the drug supply chain law to minimize supply chain disruptions and avoid drug shortages, an approach that is aligned with Healthcare Distribution Alliance’s (HDA) request for a two-year enforcement delay of DSCSA’s pharmaceutical tracking provisions. (RELATED: Pharmaceutical distributors seek two-year delay in DSCSA tracking rules, Regulatory Focus 28 July 2023)

Legislators said that such an approach would “provide flexibility while allowing product to still move through the supply chain.”

DSCSA requires manufacturers, wholesalers, distributors and dispensers to exchange serialized product information, which marks the culmination of the law’s phased implementation.

The legislators also want FDA to evaluate and inform them of the steps they are taking by 15 September to address potential disruptions and shortages resulting from DSCSA noncompliance. These steps include assessing the readiness of trading partners to meet the enhanced distribution requirements under DSCSA and how FDA is using its internal data to assess such readiness.

FDA told Regulatory Focus that the agency has received the letter and “will respond directly to the members of Congress.”

Letter, Press statement

Lawmakers, concerned about shortages, urge FDA to assess DSCSA readiness

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