Loren Data's SAM Daily™

FBO DAILY ISSUE OF OCTOBER 28, 2005 FBO #1432
SOURCES SOUGHT

R -- Access to Data on Pharmaceutical Sales, Promotional and Advertising Data

Notice Date

10/26/2005
 

Notice Type

Sources Sought
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

Reference-Number-1009855
 

Response Due

11/10/2005
 

Archive Date

11/25/2005
 

Description

This announcement constitutes a Sources Sought Synopsis. Responses to this publication are solicited to identify qualified sources. This is not a request for a formal proposal. The anticipated NAICS Code for this acquisition is 541990 with a size standard of $6M. This synopsis seeks to identify contractors that can provide access to data representing pharmaceutical sales, promotional, and advertising strategies at a national level in the U.S. The pharmaceutical sales data shall include but is not limited to sales to retail pharmacies, mail order houses, long-term care facilities, non-federal hospitals, federal facilities, clinics, home healthcare settings specialty pharmacies, and other types of pharmacies, if available. The type of sales data captured shall include both volume and dollar sales. Volume shall include measures of weight (i.e. kilograms, conversion factors to permit calculation of weight of active ingredient); counts of packages (i.e. shipping units, shelf keeping units); and counts of standard dosages (i.e., tablets/milliliters). Dollar sales shall include the amount of money spent on a product acquired from manufacturers and drug wholesalers by retail pharmacies, mail-order houses, long-term care facilities, non-federal hospitals, federal facilities, clinics, home healthcare settings specialty pharmacies, and other types of pharmacies. Available price measures should be as broad as possible and include a minimum of exit manufacturer prices, wholesale acquisition cost and average retail price measures along with details of computation. The pharmaceutical promotional and advertising data shall include but is not limited to expenditures for promotional contacts to office- and hospital-based physicians; product samples to office-based physicians; product advertising in medical journals; and direct-to-consumer advertising. Direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process. The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products. Access to data on pharmaceutical sales, promotional and advertising data would help FDA to respond expeditiously to serious public health or regulatory issues. FDA is not interested in developing this database and expects any qualified organization to own the data as well as the means to access the data. FDA Requirements: A. Provide FDA personnel with real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available, data with the capability of providing national-level estimates of pharmaceutical sales. B. Data concerning sales and promotional information shall include current data on product- and substance- specific sales to health care institutions. Updated information on sales shall be available on a monthly and yearly basis. Historical sales data shall also be available for trending and forecasting. C. Provide FDA personnel with the ability to use these data to analyze and describe national patterns of pharmaceutical sales through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel. D. Provide FDA personnel with national estimates of product sales, sampling and promotional expenditures data as well as the content and message of pharmaceutical detailing and advertising campaigns. A short term trial subscription for a maximum of four FDA evaluators for evaluation of product performance, at no cost to the FDA, to the full, commercially available version of the database will be required. Access to the data for this trial subscription shall last a minimum of 30 days, and shall include direct access, documentation, and technical support for the entire trial subscription period. Interested parties shall submit a capability statement not to exceed 10 pages no later than November 10, 2005 to one of the following addresses: Via U.S. Mail: Food and Drug Administration, OAGS/DSCI/HFA-500 Attn: Katharine Minker, 5600 Fishers Lane, Rockville, MD 20857. Via FedEx or Other Delivery Service: Food and Drug Administration, OAGS/DSCI/HFA-50o Attn: Katharine Minker, 5630 Fishers Lane, Room 2004, Rockville, MD 20852. Note: Responses must reference Request for Information (RFI) number 1009855.
 

Place of Performance

Address: Rockville MD

Zip Code: 20852

Country: USA
 

Record

SN00921092-W 20051028/051026211801 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |