DHHS/PHS/FDA/Office of Facilities, Acquisitions, And Central Services, Division Of Contracts and Program Management, HFA-511(ITCB), 5600 Fishers Lane, Rockville, MD 20857

D -- PHARMACEUTICAL MARKETING DATABASE SERVICES SOL 223-00-5501 DUE 080500 POC Julie Pearson, Contract Specialist -- Phone 301-827-7155, Fax 301-827-7151 E-MAIL: Julie Pearson, Contract Specialist, FDA, jpearso1@oc.fda.gov. The Food and Drug Administration and the Center for Drug Evaluation and Research intends to issue a solicitation for a contract to access drug utilization, advertising, and sales data. These resources will be used to assist our mission to describe prescription drug, biologic, and over-the-counter product utilization at a national level in the U.S. These databases should include individual- and aggregate- level data concerning dispensed prescriptions on a product- and substance-specific level, or products prescribed or recommended through physician practice. Basic demographic information for patients receiving the dispensed prescriptions would be desirable. In addition, information on indication for drug therapy, or a reasonable proxy thereof, is highly desirable. Timely product-specific sales data to health care providers and institutions should also be available. The FDA will require the ability to use these resources to estimate drug utilization, advertising, and sales patterns in the total U.S. population, and possibly in selected sub-populations of interest. This may involve the use of projection methodology, which must be valid, reliable and robust (with regard to drug utilization specifically) and the methods fully disclosed to the FDA. If such a methodology has not been developed, the ability to collaborate with the FDA to develop it within a reasonable timeframe is necessary. Demographic information of all patients and/or institutions included in the sample used for projection should also be available. Access to these data should be unlimited, direct, desktop and in real-time. The access should be via Internet, Telnet, through a local area network or some other multi-user alternative. If access is through an interface, it must be user-friendly and transparent. Onsite demonstration of these databases will be required, as well as training, documentation and a level of ongoing technical support. Full disclosure of database construction, coding and configuration is required to allow Agency staff to appropriately interpret findings and projections. For regulatory requirements, FDA will need the ability to download and archive data. No personal patient identifiers would be required and appropriate clearance mechanisms would be established pertaining to FDA's use of the data in a public forum. All responsible sources may submit a bid, proposal, or quotation which shall be considered. Interested offerors may request a copy of the solicitation by sending a written request by mail, fax or email to: Food and Drug Administration, Attn: Julie Pearson (HFA-511, Room 2121) 5630 Fishers Lane, Rockville, MD 20857 -- FAX: 301-827-7151 -- Email: jpearso1@oc.fda.gov In addition, the FDA is also conducting a market survey. Interested offerors should provide catalogs, brochures or any descriptive literature about the services, systems or products that they currently have available that would satisfy the above requirement. This information should be sent to the above address by July 3, 2000. Please indicate if you are a large or small business as well. Posted 06/16/00 (W-SN465480). (0168)

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