Novartis Pharmaceuticals Corporation, B-285038, July 6, 2000

B-285038 Jul 06, 2000 Jump To VIEW DECISION RELATED PAGES GAO CONTACTS Highlights DIGEST Solicitation provision requesting the submission of an implementation plan as part of the technical proposal is not ambiguous. Novartis argues that the RFP is ambiguous with regard to the requirement that proposals address how the contractor will operate and maintain a clozapine registry. The RFP contemplates establishing a supply source that will provide an estimated 33. Is used for the treatment of schizophrenia. /2/ There are some serious potential risks of side effects from the use of clozapine. The most significant side effect is agranulocytosis or neutrapenia. The registry is normally checked prior to the beginning of treatment with clozapine. Have access to the registry. The contractor under the RFP will also be required to operate and maintain a clozapine registry. View Decision Matter of: Novartis Pharmaceuticals Corporation File: B-285038 Date: July 6, 2000 DIGEST Attorneys DECISION Novartis Pharmaceuticals Corporation protests the terms of request for proposals (RFP) No. 797-NC-00-0043, issued by the Department of Veterans Affairs (VA), for the drug clozapine. Novartis argues that the RFP is ambiguous with regard to the requirement that proposals address how the contractor will operate and maintain a clozapine registry. We deny the protest. The RFP provides for the award of a fixed-price contract with a base period of 1 year with four 1-year options. The RFP contemplates establishing a supply source that will provide an estimated 33,401 bottles of clozapine per year for purchase through VA's Pharmaceutical Prime Vendor (PPV) program. /1/ RFP at 3. Clozapine, originally manufactured by Novartis under their trademark Clozaril, is used for the treatment of schizophrenia. /2/ There are some serious potential risks of side effects from the use of clozapine. The most significant side effect is agranulocytosis or neutrapenia, a potentially fatal blood disorder that can be reversed if detected early. The agency explains that due to the risk of agranulocytosis, the Food and Drug Administration (FDA) "has restricted the distribution of clozapine since its introduction to the market" and mandated that a monitoring system be in place before clozapine can be distributed. Agency Report at 2. Novartis, as the original manufacturer of clozapine, developed the first Clozapine National Registry, and agreed with FDA, upon the introduction in 1997 of a generic version of clozapine, to maintain a single database which includes a list of those individuals who should not be treated with clozapine again due to the occurrence of certain side effects. Id. at 2-3. The registry is normally checked prior to the beginning of treatment with clozapine, and all clozapine manufacturers, including Novartis, have access to the registry. Id. at 3. Accordingly, in addition to supplying clozapine, the contractor under the RFP will also be required to operate and maintain a clozapine registry. RFP at 3. The RFP includes detailed instructions for the preparation of proposals. The solicitation requests that that offerors submit separate business and technical proposals. RFP at 31. The solicitation specifies that technical proposals shall include, among other things, an implementation plan. Id. The RFP (at 4) states that the implementation plan shall detail how and when the Clozapine registry database will be populated and submitted to the National Clozapine Coordinating Center in Dallas, Texas. This plan must also demonstrate how the offeror will accomplish all the requirements of the Clozapine registry (See Attachment G for suggested format for this plan). The solicitation includes six pages detailing the minimum requirements for the operation and maintenance of a clozapine registry. RFP at 5-10. The solicitation adds that the offerors should address each issue concerning their proposed implementation plans completely and in enough detail "to assure the Government of the offeror's understanding and capability to perform the cited requirements." RFP at 31. The RFP also states here that "[t]he Government will assess the realism and viability of the offeror's plan(s)," and that the implementation plan "will be evaluated to assure that the offeror demonstrates how all required tasks would be met." RFP at 31-32. The solicitation states that award will be made to the offeror submitting the proposal determined to be most advantageous to the agency. The RFP further provides that price will be the most important factor; followed by the past performance and implementation plan evaluation factors, which are equal in importance; and the small disadvantaged factor, which is significantly less important. RFP at 32. Novartis protests that the solicitation is ambiguous concerning the RFP's requirement for the submission of an implementation plan.