Takeda Group's Gammagard (Notice of Intent to Sole Source)

Acquisition Description:

This is a Notice of Intent, not a request for proposal.  The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with Takeda Pharmaceutical Company Limited.

The National Institutes of Health (NIH) Clinical Center (CC) is a clinical research hospital providing all medical services for patients participating in human research protocols of the NIH. The CC Pharmacy department provides a range of pharmaceutical care services to inpatients and outpatients enrolled in clinical trials. The CC Pharmacy department is responsible for acquiring the supply of medications required for patient care. This includes the purchase of Gammagard S/D 10gm and Gammagard S/D 5gm kits.

The NIH CC Pharmacy is requesting the purchase of 10 bottles each of Gammagard S/D 10gm and Gammagard S/D 5gm kits and as needed to provide anticipated current patient care need.

Justification:

TAKEDA Group is the only responsible source for Gammagard S/D. There are multiple patients in the NIH currently on therapy with Gammagard S/D and additional patients may be transferred to the NIH for evaluation and treatment. Gammagard S/D is on the Clinical Center’s formulary, requiring a supply to be available in the Pharmacy Department at all times to support ongoing patient care. The NIH needs to keep using the same items to keep treatment consistent.