Boehringer Ingelheim Pharmaceuticals, Inc., B-294944.3; B-295430, February 2, 2005

Boehringer Ingelheim Pharmaceuticals, Inc., B-294944.3; B-295430, February 2, 2005 TITLE: Boehringer Ingelheim Pharmaceuticals, Inc., B-294944.3; B-295430, February 2, 2005 BNUMBER: B-294944.3; B-295430 DATE: February 2, 2005 ********************************************************************** Decision Matter of: Boehringer Ingelheim Pharmaceuticals, Inc. File: B-294944.3; B-295430 Date: February 2, 2005 John A. Burkholder, Esq., and Frank Rapoport, Esq., McKenna Long & Aldridge, for the protester. John S. Pachter, Esq., Jonathan D. Shaffer, Esq., and Sophia R. Zetterlund, Esq., Smith Pachter McWhorter & Allen, for AstraZeneca Pharmaceuticals LP, an intervenor. Melbourne A. Noel, Jr., Esq., Phillipa L. Anderson, Esq., and Philip S. Kauffman, Esq., Department of Veterans Affairs, for the agency. Ralph O. White, Esq., and Christine S. Melody, Esq., Office of the General Counsel, GAO, participated in the preparation of the decision. DIGEST Protests arguing that solicitations for formulary drugs are unduly restrictive because the solicitations limit competition to those drugs within the class that treat certain conditions is denied where the limits on competition reasonably reflect the agency's needs. DECISION Boehringer Ingelheim Pharmaceuticals, Inc. (BI) protests the terms of two solicitations issued by the Department of Veterans Affairs (VA) for Angiotensin II Receptor Antagonists, also known as Angiotensin II Receptor Blockers (or ARBs), for inclusion on the VA's National Formulary. One solicitation (request for proposals (RFP) No. RFP-797-NC-04-0016) seeks one of two identified ARBs for the treatment of patients with both hypertension and type 2 diabetes mellitus with nephropathy; the other (RFP No. RFP-797-NC-05-0003) seeks one of two identified ARBs for the treatment of patients with heart failure. BI, the manufacturer of an ARB not identified under either solicitation, argues that these solicitations are unduly restrictive because they exclude ARBs that treat simple hypertension, but do not treat the other conditions identified. We deny the protests. BACKGROUND BI manufactures one of seven ARBs available in the U.S., all of which are approved by the Food and Drug Administration (FDA) for the treatment of hypertension. Drug Class Review at 1-2. BI's ARB is referred to as Telmisartan, and is marketed as Micardis(R). All seven FDA-approved ARBs are viewed as equally effective in treating hypertension. Id. at 6. The RFP seeking an ARB for the treatment of both hypertension and diabetic nephropathy (RFP 0016) was issued on August 23, 2004, and is the subject of a recent decision by our Office (Bristol-Myers Squibb Co., B-294944.2, Jan. 18, 2005, 2005 CPD PA ___). On its face, the RFP limited this competition to two ARBs--Irbesartan (manufactured by BMS and Sanofi, marketed as Avapro(R)) and Losartan (manufactured by Merck, marketed as Cozaar(R)). The RFP seeking an ARB for the treatment of heart failure (RFP 0003) was issued on October 14, 2004. It limits competition to two other ARBs--Candesartan Cilexetil (manufactured by AstraZeneca, marketed as Atacand(R)) and Valsartan (manufactured by Novartis, marketed as Diovan(R)). Both RFPs anticipated award of a fixed-price, indefinite-quantity contract for a base period of 1 year, with up to four 1-year options. Prior to releasing these solicitations, the VA made several decisions that are reflected in these two limited competitions. In summary--but discussed in greater detail below--these decisions were: (1) to not add an ARB to the VA's National Formulary for the treatment of hypertension; (2) to select for the formulary one of the two ARBs shown to be effective in treating diabetic nephropathy; and (3) to select for the formulary one of two other ARBs shown to be effective in treating heart failure. These decisions were made by doctors from the VA's Pharmacy Benefits Management (PBM) Section, together with the VA's Medical Advisory Panel (MAP)--a panel of 13 physicians throughout the VA and the Department of Defense. The process began with a Drug Class Review of all available ARBs, which is appended to both RFPs. Using the findings of the Drug Class Review, the VA's PBM and MAP doctors prepared a second document explaining the VA's approach to purchasing ARBs. This document--also appended to both RFPs--is entitled "Medical Determination of Minimum Needs for VA National Formulary Selection of an [ARB]," hereinafter the "Medical Needs Determination." The VA decided not to add an ARB to its National Formulary for the treatment of simple hypertension because ARBs are not the VA's preferred method of treating simple hypertension. Medical Needs Determination at 3; Declaration of the MAP Chairperson, Dec. 13, 2004, at 3-4.