Sources Sought Notice: Access to Data on Pharmaceutical Sales.
Sources Sought Notice: Access to Data on Pharmaceutical Sales.
MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION
The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is conducting market research to support the Center for Drug Evaluation and Research (CDER) requirement for access to real-time, unlimited, immediate, direct, multi-user, access to currently existing data on pharmaceutical sales.
This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the required supply item/services. This notice is for planning purposes only, and does not constitute an invitation for Bids, Request for Proposal or Request for Quotation or an indication the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.
Scope of Work:
Contractor’s respondent to this notice shall have the capabilities to furnish the necessary personnel, materials, services, equipment, facilities, and otherwise do all things necessary for the performance of the work described below.
Capabilities Required:
The contractor shall have the capability to provide data resource(s) to access national-level pharmaceutical sales data. These data resource(s) should have the capability to capture sales that occur through all types of distribution arrangements, including wholesalers as well as direct-buy with manufacturers.
The data resource(s) shall have the capability to further allow sales data to be broken down by channels of distribution (e.g., retail, mail-order, long-term care, for-profit and not-for-profit, federal and non-federal, clinics, institutional/non-institutional, specialty pharmacies, etc.) and by U.S. geographic regions. These data resource(s) shall also have the capability to include measure(s) for the volume of pharmaceutical product sales (dollars, units, SKU, etc.) by manufacturer, and the capability to obtain raw/sample numbers as well as projected numbers.
The data resource(s) shall the capability to have basic data elements to capture company, drug, and pricing information. These data shall be provided in monthly and annual increments for all prescription and non-prescription, generic, brand and over-the-counter (OTC) drugs and biologics. These data resource(s) shall have raw/sample numbers, projected numbers, and confidence intervals available, with immediate access if possible, throughout the length of the contract.
The company-specific data elements shall have the capability to include (but are not limited to): name of corporation (parent company); name of manufacturer/distributor (marketing company); and company size indicators (e.g., total products, sales, gross profit, revenue, etc.). DUNS numbers (or other unique company identifiers) of the marketing company shall also be included (preferred).
The drug-specific data elements shall have the capability to include for all prescription, brand, generic and OTC drugs and biologic products: product names (U.S. proprietary and non-proprietary); volume measures (e.g., packages, units, extended units, SKU, etc.); name of corporation/manufacturer; originator status (e.g., originator, re-packager, branded or private label, etc.); molecule(s); active ingredient(s); chemical family; composition (e.g., single-ingredient or combination product); therapeutic class identifier; National Drug Code (NDC) or other drug code (specify coding system used); route of administration; dosage form; strength; molecular salt (if applicable); package details (e.g., form, strength, size or volume); product age (e.g., date first marketed); and—patent details (e.g., date first patent granted, date of patent expiry.
The pricing-specific data elements shall have the capability to include for all prescription, brand, generic and OTC drugs and biologic products: exit manufacturer price (price paid by wholesaler or pharmacy to the manufacturer); wholesale price (price paid by pharmacy to wholesaler); retail price (price paid by customer to pharmacy); and average retail markup (difference between the retail and wholesale prices). For each data element, the Contractor shall have the capability to provide descriptive statistics along with the method of computation.
The Contractor shall have the capability to provide the following information relating to any projection methodologies used to transform raw totals into final data: distribution of types of facilities and sales channels (to include numbers and percents) compared to the national coverage by regions (Northeast, Midwest, South, West); and distribution of sales data characteristics by geography (e.g., urban, rural, etc.), sales volume, type (independent, chain, etc.), and four census regions.
Characteristics of the Data Resource(s)
A. The contractor shall have the capability to provide national-level pharmaceutical sales data that is currently existing and commercially available product that shall provide immediate access with the capability of providing characterization of current product- and substance-specific drug and biologic sales data to health care settings and facilities.
B. The data shall have the capability of providing both current and historical national-level pharmaceutical sales data.
C. The Contractor shall have the capability to provide national estimates of pharmaceutical sales data using projection or other appropriate methodologies, which shall be valid, reliable, and robust and a full disclosure of data collection procedures required.
Access to the Data Resource(s)
D. The contractor shall have the capability to provide access to the data that is immediate, unlimited, direct, desktop and in real-time.
E. The data resource(s) shall have the capability to be accessed via secure Internet or network-based methods permitting simultaneous, multi-user access through user-friendly data query tool(s).
F. The Contractor shall have the capability to maintain continuous access to current national-level pharmaceutical sales data resource(s).
G. The contractor shall have the capability to provide access shall be through an interface that is user-friendly, transparent, and flexible.. Minimally, the interface shall have the capability to provide both predefined (e.g., canned) and custom reports.
H. The Contractor shall have the capability to provide the ability to download (or obtain in a timely manner using other means) large amounts of data (i.e., for many drugs and time periods at once).
Capability Statements:
Responses to this sources sought shall unequivocally demonstrate the respondent’s capabilities to provide the services/data above. Though the target audience is small business, all interested parties may respond. At a minimum, responses shall include the following:
1. Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.
2. Past Performance information shall include date of services, description, dollar value, client name,
Client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include DUNS number and size status) if not the respondent.
3. Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing.
4. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.
Response Instructions:
Interested parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 1:00 PM Eastern Time on April 4th, 2017 to Christopher.mcgucken@fda.hhs.gov.
Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).
Christopher R. McGucken, Contract Specialist, Phone (240) 402-7566, Email christopher.mcgucken@fda.hhs.gov
