Hoechst Marion Roussel, Inc., B-279073, May 4, 1998

B-279073 May 04, 1998 Jump To VIEW DECISION RELATED PAGES GAO CONTACTS Highlights Solicitation for various dosages of a drug is improper where the solicitation fails to realistically state agency's estimated requirements for the various dosages. Where the agency determines that any of the available formulations will meet its requirements. Agency's medical judgment regarding the relative efficacy of the different formulations is not appropriate for review within the context of a bid protest. 3. General Accounting Office will not consider protest that solicitation requirement violates Federal Healthcare Anti-Kickback Act. Those opinions are binding on the parties seeking the Secretary's opinion. This drug is currently available under multiple-award Federal Supply Schedule (FSS) contracts (the three potential competitors each have an FSS contract for Diltiazem). View Decision Matter of: Hoechst Marion Roussel, Inc. File: B-279073 Date: May 4, 1998 DIGEST Attorneys DECISION Hoechst Marion Roussel, Inc. (HMR) protests the terms of request for proposals (RFP) No. M5-Q1-98, issued by the Department of Veterans Affairs (VA) for sustained action (administered once daily) Diltiazem, a calcium channel blocker used primarily in the treatment of hypertension. HMR argues that the RFP improperly permits VA to make a post-award sole-source modification of the resulting contract to include dosage strengths and package sizes not subject to evaluation during the acquisition. /1/ HMR also maintains that the RFP fails to provide for consideration of the competing products' relative efficacy in connection with the agency's technical evaluation, and improperly calls for the winning vendor to bear the cost of recalibrating VA's automatic drug dispensing equipment. We sustain the protest. The RFP contemplates the award of a single requirements-type contract for all of VA's requirement for Diltiazem for a base year and four 1-year options. This drug is currently available under multiple-award Federal Supply Schedule (FSS) contracts (the three potential competitors each have an FSS contract for Diltiazem). VA currently dispenses some 23 million doses of Diltiazem per year in varying strengths and, depending on the vendor, the product is commercially available in 120, 180, 240, 300 and 360 milligram (mg.) dosages. Pursuant to VA's national formulary program, the agency seeks to establish, through the current procurement, a single, nationwide supplier of Diltiazem to ensure the availability and consistency of the drug, and to take advantage of volume-based pricing. For evaluation and award purposes, the RFP provides that price and past performance will be considered, with price more important. The contract line items are divided among several dosage strengths and package sizes (for example, 120 mg. dosages available in 30, 90 and either 1,000 or 5,000 dose packages), and the RFP provides that an aggregate price for each offer will be arrived at by adding the cumulative total of the proposed prices for all contract line items. The RFP further provides that some, but not all, of the commercially available dosage strengths will be evaluated for award purposes, specifically, that only 120, 180 and 240 mg. dosages will be evaluated. As for other available strengths, the RFP provides: If additional strengths are available, they should be included in the offer, however they will not be made part of the evaluation process. Any additional strength may be added after award by mutual agreement through negotiation between the contractor and Government. Furthermore, any commercially offered packaging sizes should be made available to the Government after award. VA states that it has a known requirement for higher dosages (specifically 300 mg. and 360 mg. dosages), and will meet that requirement either through a single, large pill under the terms of the above provision (if the contractor manufactures larger pills), or with a combination of lower dosage pills (if the contractor manufactures only the three lower dosages). VA explains that it has limited the RFP to only the lower dosage strengths because these are common to all three of the prospective vendors, and maintains that this will foster broader competition, since only one firm manufactures the full range of dosage strengths (i.e., up to 360 mg.). DOSAGE REQUIREMENTS HMR alleges that the solicitation does not accurately reflect the agency's needs and that any modification under the provision quoted above will constitute an improper sole-source award to the successful contractor for dosage strengths that were not evaluated. For example, HMR has a 300 mg. dosage available, and the intervenor in this protest, Forest Pharmaceuticals, has 300 and 360 mg. dosages available.