FDA Support Services: Access to Data on Pharmaceutical Sales

Added: Aug 11, 2017 9:55 am The purpose of this amendment is to extend the solicitation response date. As a result of this amendment, the solicitation due date shall be changed from August 11th, 2017 1:00PM Eastern Time to Tuesday August 15th, 2017 3:00PM Eastern Time.

Added: Aug 04, 2017 9:19 am The purpose of this amendment is to extend the solicitation response time for seven day (7) in response to questions received. As a result of this amendment, the solicitation due date shall be changed from August 4th, 2017 1:00PM to August 11th, 2017 1:00PM Eastern Time.

A seperate amendment will be posted containing the Q&A.

Added: Jul 21, 2017 5:30 pm The Food and Drug Administration's Center for Drug Evaluation and Research has a need for access to national-level pharmaceutical sales data.

Solicitation number FDA-RFP-17-1179520 is issued as a Request for Proposal (RFP).

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information from FAR Part 13.5 and included in this notice. The resultant task orders will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-95. The North American Industrial Classification System (NAICS) code for this procurement is 541990, All Other Professional, Scientific, and Technical Services.

The Government intends to award a hybrid Firm-Fixed-Price, Labor Hour and Indefinite Delivery/Indefinite Quantity (IDIQ) contract vehicle for a duration of five (5) years, consisting of one (1) base year, and four (4) optional periods. The IDIQ portion of the contract intends to issue Firm-Fixed-Price, and Labor Hour Task Orders.

The IDIQ guaranteed minimum amount will be the amount of the award fixed price portion of the contract. The contract maximum ceiling amount for the IDIQ portion will be $850,000.00 over five (5) years, inclusive of options.

A vital part of FDA and CDER's mission is to promote and protect the public health. Offices within CDER take a variety of approaches to meet these broad goals. For example, the Office of Surveillance and Epidemiology (OSE) evaluates drug risks and promotes the safe use of drugs by the American people. The Drug Shortage Staff (DSS) aims to minimize the impact of shortages of drug products, by working to avoid such shortages or to mitigate the effects when shortage is unavoidable. Finally, the Office of Program and Strategic Analysis (OPSA) conducts economic and quantitative analyses of proposed and existing policies.

To fulfill these missions and other program functions, CDER requires access to national-level pharmaceutical sales data and, as needed, international data to estimate and forecast trends in pharmaceutical sales, pricing, and volume of distribution throughout various settings of care. Continued access to these data allows the FDA to respond expeditiously to questions relating to drug safety, the impact of regulatory policies, and to potential drug shortage situations, helping the Agency to make more informed decisions about matters that affect the health of Americans.

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.

In early 2005, FDA commissioned the Institute of Medicine (IOM) to conduct a study to examine the U.S. drug safety system. In September 2006, the IOM report entitled, "The Future of Drug Safety: Promoting and Protecting the Health of the Public" was released and outlined numerous ongoing and future activities designed to continue to strengthen the FDA's drug safety program. OSE contributes to this effort by evaluating drug risks and promoting the safe use of drugs by the American people. Specific recommendations in the IOM report addressed modernizing the drug safety program including activities for the expansion of database resources.

In addition, Title IX of the Food and Drug Administration Amendments Act of 2007 (FDAAA 2007) contains numerous provisions related to post-marketing safety and communication of safety information. A subset of those provisions calls for enhanced authorities for accessing disparate data sources and establishing and improving procedures to identify drug use data trends on a national level.

The ability of FDA to respond expeditiously to the increasing number of post-marketing issues is of paramount importance to the overall public safety. Continued access to these data complement and strengthen the utility of the passive reporting system currently in place by providing broad estimates of how drugs are sold to all types of institutions in the health system. These data resources also provide a denominator, or context, for understanding adverse event reports; for modeling drug risks based on usage patterns; and for calculating patient-based, adverse event reporting rates for drugs.

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's authority to fund research projects is set out in section 301 of the Public Health Service Act (PHSA 42 U.S.C. 241).

For full details/description, please refer to attached document FDA-RFP-17-1179520.pdf