Pharmaceutical Products for CDER Research Studies - IDIQ

The FDA Office of Acquisition and Grant Services seeks a reliable supplier of currently marketed pharmaceutical drug products for Center for Drug Evaluation and Research studies under an IDIQ contract, with quotations due May 15, 2026 at 1:00 P.M. Central Time. This is unrestricted full and open competition with no small business set-aside.

Place of performance is the United States, with deliveries to FDA offices, external research sites, and international locations. The incumbent contractor is WE Pharma, LLC, under previous contract 75F40120D00032 (September 30, 2020 through September 29, 2025) with a prior IDIQ ceiling of $9,500,000.

The contract covers brand name and generic pharmaceuticals spanning small molecule therapeutics, peptide therapeutics, drug-device combination products, and contrast agents. The comprehensive drug product list in Attachment 1 specifies 96 pharmaceutical products; contractors must submit firm fixed pricing for all listed items and indicate which products they can supply. Delivery requirements mandate seven business days for domestic FDA offices and research sites, and 14 business days for international locations. All shipping and handling costs must be included in quoted prices under FOB Destination terms.

Contract structure spans five one-year ordering periods from September 1, 2026 through August 31, 2031, with a guaranteed minimum of $25,000 and an estimated maximum not to exceed $4,000,000 across all periods, though this ceiling may increase by mutual agreement. NAICS code is 325412 with a small business size standard of 1,300 employees. Evaluation weighs technical capability and past performance more heavily than price unless deemed essentially equal among offerors. Quotations must include completed pricing attachment, technical specifications, past performance information within three years, a small business subcontracting plan (unless offeror is small business or has an approved commercial plan), and an Accessibility Conformance Report for Section 508 non-compliance items. Contracting officer is Nick Sartain at (301) 796-1988; payment is net 30 days after government acceptance through the Department of Treasury's Invoice Processing Platform.