Schering Corporation, B-286329.3; B-286329.4, February 2, 2001

Schering Corporation, B-286329.3; B-286329.4, February 2, 2001 TITLE: Schering Corporation, B-286329.3; B-286329.4, February 2, 2001 BNUMBER: B-286329.3; B-286329.4 DATE: February 2, 2001 ********************************************************************** Schering Corporation, B-286329.3; B-286329.4, February 2, 2001 Decision Matter of: Schering Corporation File: B-286329.3; B-286329.4 Date: February 2, 2001 Alex D. Tomaszczuk, Esq., and John E. Jensen, Esq., Shaw Pittman, for the protester. Maura C. Brown, Esq., Department of Veterans Affairs, for the agency. Susan K. McAuliffe, Esq., and Christine S. Melody, Esq., Office of the General Counsel, GAO, participated in the preparation of the decision. DIGEST Protest of terms of solicitation for formulary drug item is denied where challenged requirements reasonably reflect agency's needs and evaluation scheme provides a reasonable basis for the evaluation of proposals for award. DECISION Schering Corporation protests the terms of request for proposals (RFP) No. RFP-797-NC-00-0073, issued by the Department of Veterans Affairs (VA) for non-sedating antihistamines (NSA). Schering contends that the solicitation is flawed for improperly grouping two of the protester's NSA formulations under the RFP. Schering also contends that the solicitation's weighted evaluation scheme does not provide a reasonable basis for the evaluation of proposals for award. We deny the protest. The RFP, issued on August 3, 2000, contemplates the award of a fixed-price contract, for a 1-year base period and four 1-year option periods, to the lowest-priced, responsible offeror under one of the solicitation's alternate contract line items (CLIN) for a single NSA (fexofenadine or loratadine) to meet stated VA, Indian Health Service (IHS), [1] and Department of Defense (DoD) oral solid dosage NSA requirements. This procurement is part of the agency's efforts to standardize the availability of pharmaceuticals and medical/surgical items, through the use of a national formulary program. [2] The successful NSA will be added to the VA national drug formulary to be prescribed by VA physicians, and distributed by VA's medical facilities and Consolidated Mail Out Patient Pharmacies (CMOP), to current NSA users and new patients. If, however, a clinical need is cited by a VA physician for the patient's use of a different, non-formulary NSA, the prescribed non-formulary drug will be made available to the patient through the VA's non-formulary approval process. Agency Report at 2. For DoD, the national contract awarded under the RFP will only apply to initial (new patient) prescriptions for an NSA for direct care patients at a DoD military treatment facility (MTF). [3] The DoD formulary program, similar to the VA's, also provides for a non-formulary drug approval process based on clinical need. Id. The class of NSAs available under the formulary program is expected to "close" upon award of the national contract under the RFP; accordingly, during the contract period, medical facilities will be unable to add any other oral solid dosage NSA to their individual formularies. Supplemental Agency Report at 2. The solicitation provides for competition between the two identified NSAs, fexofenadine and loratadine, which, the agency reports, have been determined by agency pharmacists to be therapeutically interchangeable. Agency Report at 8; Supplemental Agency Report at 6. Fexofenadine is manufactured by Aventis Pharmaceuticals and is marketed under the name Allegra�. Loratadine is manufactured by the protester, Schering, and is marketed under the name Claritin�. The RFP's pricing schedule, as amended, sets out separate CLINs for alternate offers of solid dosage formulations of the two NSAs. RFP amend. 7, attach. 1. For example, fexofenadine is solicited in two available forms: 180-mg tablets (for once-daily dosage) and 60-mg capsules or tablets (for twice-daily dosage). Separate CLINs (0001-0003, respectively) are provided in the RFP's schedule, as amended, to allow for alternate offers based on either the 180-mg or 60-mg formulations of fexofenadine, or both. Under CLIN 0003, which provides for an alternate offer of both fexofenadine formulations, prices for each of the two formulations (set out as CLINs 0003a and 0003b) are to be weighted to reflect the agencies' anticipated use of each formulation. [4] The RFP pricing schedule also provides for alternate offers of Schering's loratadine product based on that NSA's two available oral solid dosage formulations: 10-mg loratadine tablets (for once-daily dosage), and 10-mg loratadine rapidly-disintegrating tablets (RDT) (also for once-daily dosage). [5] CLIN 0004 provides for offers of 10-mg loratadine tablets. A separate CLIN is not provided for the 10-mg loratadine RDT; the agency explains that this is due to the minimal anticipated use of the RDTs. Supplemental Agency Report at 4, 8.