Lawmakers urge FDA to consider broad exemptions from DSCSA to minimize supply chain disruptions

Members of Congress are urging US Food and Drug Administration (FDA) Commissioner Robert Califf to consider establishing a broad category of exemptions from the enhanced tracing requirements under the Drug Supply Chain Security Act (DSCSA) to allow more time for trading partners to stabilize data exchanges and to avoid drug shortages once the law takes effect on 27 November.

The request was made in a 7 October letter from Reps. Troy Balderson (R-OH) and Lori Trahan (D-MA) and co-signed by other House lawmakers, who asserted that, “Absent government intervention, there will likely be disruptions that could lead to drug shortages and patients being unable to access critical medications.”

FDA’s current policy is to grant individual waivers, exceptions, and exemptions (WEE), rather than issuing dispensations that would affect specific products or transactions on a broader basis.

The legislators praised FDA’s decision to implement a stabilization period to allow trading partners more time to establish technical connections for serialized data exchange. However, they asserted that more help is needed to minimize supply chain disruptions. FDA announced in August 2023 it would give firms one more year to comply with the requirements for system-wide track and trace. (RELATED: FDA gives firms one-year reprieve from DSCSA track and trace requirements, Regulatory Focus 25 August 2023)

Members said they were also “encouraged” by FDA’s decision to exempt many small dispensers from DSCSA requirements until 27 November 2026. Yet, the letter states that “given the varying degrees of readiness among trading partners across the supply chain, we believe that the FDA needs to take additional steps beyond that exemption to prevent shortages or access constraints.”

Legislators said that “critical gaps particularly regarding data quality and accuracy” were observed at the FDA-Partnership for DSCSA Governance (PDG) joint public meeting held in June.

They noted that FDA has received a large volume of WEE requests and want the agency to evaluate and respond to such requests on a case-by-case basis to ensure continuity across the supply chain. They also want FDA to explore whether the volume and nature of WEE requests “justifies that FDA on its own establish exemption(s) for specific products or transactions from certain requirements to provide trading partners more time to stabilize data exchange.”

The lawmakers also urged FDA to consider the stepwise approach to compliance that some industry groups have advocated for, which would require manufacturers to comply with DSCSA by this November, followed by wholesalers six to eight month later, and then by pharmacies in February 2026. Additionally, they requested that FDA provide a status update by 25 October to address the number of WEE applications submitted to the agency, the timeline for reviewing and considering the WEE applications, the number of WEEs that have been granted, the number of WEEs it has rejected, and FDA’s communication strategies for engaging with industry to minimize supply chain disruption in November.

During a recent meeting sponsored by the Healthcare Distribution Alliance (HDA), legal experts said that some of their clients’ top concerns are the timing of WEE request submissions and confusion over what qualifies for a WEE under DSCSA. (RELATED: Legal experts note confusion about DSCSA waivers, exceptions and exemptions, Regulatory Focus 12 August 2024).

Letter

Lawmakers urge FDA to consider broad exemptions from DSCSA to minimize supply chain disruptions

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