6505--VISN IDIQ LENALIDOMIDE Sole Source Justification

The Department of Veterans Affairs is pursuing a sole-source award to Exelan Pharmaceuticals for the continuous supply of generic Lenalidomide, an immunomodulatory drug critical for treating multiple myeloma, anemia in myelodysplastic syndromes, and certain lymphomas. This procurement is issued under an indefinite-delivery/indefinite-quantity structure against an existing Federal Supply Schedule contract (36F79720D0227) and is justified under GSAR 538.7104-4 due to the drug’s unique regulatory constraints, specifically the FDA-mandated Risk Evaluation and Mitigation Strategy program, which restricts distribution to certified pharmacies and limits available suppliers. The contract has an estimated value of $26,272,218 and requires full compliance with current Good Manufacturing Practices, FDA regulations, and REMS program protocols, including child-resistant and tamper-evident packaging, unit-dose labeling with NDC codes, lot numbers, expiration dates, and REMS identifiers. All materials must be manufactured by Exelan Pharmaceuticals and distributed via Biologics by McKesson to VA facilities within VISN 02, with final dispensing occurring only through REMS-certified pharmacies. The procurement is urgent, intended to ensure uninterrupted patient access and regulatory compliance without disruption. Although no formal contract clauses, evaluation factors, or line-item pricing details are included in the documentation, the award is based on the contractor’s existing FSS contract and the lack of therapeutically equivalent alternatives that can meet REMS requirements. The contracting office in Albany, NY, serves as the point of administrative control, with Corey Swinton as the primary point of contact and Anthony Murray as the contracting officer, supported by HCA approval from Gerald Jacobs. No socioeconomic or small business certifications are applicable, and no alternate suppliers have been identified due to the product’s regulatory exclusivity. While delivery and inspection locations are not explicitly defined, the responsibility for compliance rests solely with the contractor, and invoicing is expected to follow standard VA and FSS electronic systems such as WAWF. The requirement to maintain consistent supply under strict regulatory oversight makes this procurement essential for veteran healthcare continuity.