6505--VISN 09 Lenalidomide Generic Pharmaceutical Drug Brand name or generic

Solicitation / RFP / RFQ

This notice is for informational and planning purposes only and does not constitute a Request for Quote (RFQ), Invitation for Bid (IFB), or Request for Proposal (RFP). The Department of Veterans Affairs (VA), Network Contracting Office 09, is seeking sources for Lenalidomide, a generic pharmaceutical drug, for the Tennessee Valley Healthcare System. This is a supply acquisition with an estimated total contract cost over the Simplified Acquisition Threshold.

• The contractor must be a Certified Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) pharmacy.

• Must be able to supply and dispense Lenalidomide in the following doses: 2.5mg, 5mg, 10mg, 15mg, 20mg, 25mg.

• Estimated yearly requirements for each dose are provided, with products to be requested on an "on demand, as needed" basis.

• The anticipated NAICS code is 325412 (Pharmaceutical Preparation Manufacturing).

• Limitations on Subcontracting requirements apply (FAR 52.219-14 and FAR 52.219-27).

• This is a source sought notice, not a solicitation. No quotes or proposals are being accepted at this time.

• Interested firms should submit capability statements to Christina.Lawrence2@va.gov by 01-23-2026, 10:00am CENTRAL TIME.

• Capability statements should address how the firm can meet SOW requirements, provide feedback, indicate business size status, confirm manufacturer/distributor status, address subcontracting limitations, confirm compliance with the Non-Manufacturer Rule, and indicate conformity with the Buy American Act or Trade Agreement Act.

• Vendors must also confirm FDA clearance for proposed products and provide details on any existing Federal Government contracts.

• The notice does not specify a set-aside. Small business requirements, including limitations on subcontracting for SDVOSB and VOSB, are mentioned.

• Potential offerors are responsible for monitoring the Governmentwide Point of Entry for future solicitations.

• Not responding does not preclude future participation.

• All information received will be handled as proprietary if marked.

Statement of Work (SOW)

To establish a reliable and continuous supply of generic Lenalidomide (by Exelan) for VISN 9 Midsouth Healthcare System, ensuring patient access and meeting regulatory obligations, including the Risk Evaluation and Mitigation Strategy (REMS) program.

• Supply and delivery of Lenalidomide in multiple strengths and formulations (capsules).
• Ensure uninterrupted availability throughout the contract period.
• Timely delivery directly to VISN 9 patients according to approved ordering procedures.
• Contractor is responsible for shipping, freight, and handling.
• Maintain sufficient inventory to meet forecast and emergency orders.
• Adhere to all applicable safety, quality, and risk management standards.
• Comply with Lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program requirements and FDA regulations.
• Provide required documentation and certifications (e.g., Certificates of Analysis).
• Support VISN 9 pharmacy or clinical staff for audits or verification.

One year from the date of award.

• Deliveries to multiple VISN 9 VAMC addresses in Tennessee and Kentucky.

• Use of secure, trackable, and appropriate delivery methods for medication.

• Each shipment must include packing slips with order number, item description, lot number, and expiration date.

• Provide product specifications (strength, formulation, packaging, labeling).

• Maintain necessary licenses and authorizations for drug distribution.

• Ensure quality assurance and regulatory compliance (cGMP, FDA).

• Conduct inspections and testing of batches.

• Handle returns or recalls.

• Provide prompt communication regarding back orders, shortages, or discontinuations.

• Comply with all records management laws and regulations, including safeguarding sensitive information and reporting data breaches.

• Complete required VA training on privacy and information security.

• Provide accurate forecasts and timely purchase orders.

• Inspect and accept/reject deliveries.

• Conduct pharmacovigilance and report adverse events.

• Generic lenalidomide is ordered and paid through Biologics by McKesson (FSS contract # 36F79720D0227).

• VHA Prescription Form required, submitted directly to Biologics by McKesson.

• Payment upon acceptance of delivered goods, via electronic funds transfer (EFT).

• Invoices must be submitted electronically.