REQ 1252383 Sales BaATTACHMENT 1 SOW CLEAN 6 22 2022.docx updated 8 23 2022.pdf

Access to Pharmaceutical Sales Data ATTACHMENT 1: Statement of Work May 2, 2022

1.0. DESCRIPTION/SPECIFICATIONS/SCOPE OF WORK

1.1 BACKGROUND

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 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.

Several prior efforts have supported CDER’s interest in obtaining access to pharmaceutical sales data. 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.

In response to reports from the Institute of Medicine (IOM), FDA is authorized by the FDA Amendments (2007) Act to expand database resources for providing advanced analyses of drug safety data to improve the quality of post-market risk/benefit analyses and enhance the ability of FDA to make timely assessments of drug safety data. 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.

https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf

The 21st Century Cures Act which was enacted in December 2016 also contains provisions for the FDA to increase surveillance and monitoring of certain medications such as opioids which aligns with CDER’s mission. This section of the Act encourages the use of real-world evidence in the analysis of post market surveillance data to enable the Agency to respond promptly to serious public health issues.

https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf

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.

CDER has previously used pharmaceutical sales data to support many of its regulatory and public health initiatives. These data provide important context for understanding adverse event reports; for instance, by allowing for modeling drug risks based on usage patterns and for calculating patient-based, adverse event reporting rates for drugs. CDER has also used these data to support several public presentations and reports, including FDA’s 2019 report, Drug Shortages: Root Causes, and Potential Solutions. 1

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).

1 https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions htts://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions

1.2 Objectives

Program Research Goals:

To provide FDA personnel with:

A. Real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available pharmaceutical sales data. Updated information on sales shall be available at least as frequently as a monthly basis, and historical sales data shall also be available for trending and forecasting

B. 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

C. Sufficient granularity of pharmaceutical sales information to obtain data on product- and substance-specific pharmaceutical sales to health care settings and facilities by channels of distribution.

1.3 Scope of Work

The Contractor shall provide the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incidental to the performance of the work as described below.

1.3.1 Pharmaceutical Sales Data Requirements [National (U.S) Sales Data]

For the purpose of this requirement, the data resource(s) shall be sufficient to meet FDA’s need to access national-level pharmaceutical sales data. The data resource(s) shall capture sales that occur through all types of distribution arrangements, including wholesalers as well as direct-buy with manufacturers.

These data resource(s) shall further allow sales data to be broken down by channels of distribution (e.g., retail, long-term care, federal and non-federal, clinics, institutional/non-institutional, mail order/specialty pharmacies, etc.). These data resource(s) shall also include measure(s) for the volume of pharmaceutical product sales (dollars, units, etc.) by manufacturer, and the ability to obtain raw/sample numbers (if possible/allowable) as well as projected numbers.

These data resource(s) shall 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 (if possible/allowable), projected numbers, and confidence intervals available, with immediate access if possible, throughout the length of the contract.

The company-specific data elements shall include (but are not limited to): name of corporation (parent company); name of manufacturer (marketing company) and the name or identifier of any intermediaries supporting the transactions such as Group Purchasing Organizations (GPOs).

The drug-specific data elements shall include for all prescription, brand, generic and OTC drugs and biologic products (including biosimilars): product names (U.S. proprietary and non-proprietary); volume measures (e.g., packages, units, extended units, etc.); name of corporation/manufacturer, include brand status (brand, generic and branded generic), Rx status (Rx, OTC); originator status (e.g., originator, re-packager, branded or private label, etc.); product type (e.g., biologic or small molecule); molecule(s); active ingredient(s); (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); date first marketed;

and—date of protection expiry.

The pricing-specific data elements shall include for all prescription, brand, generic and OTC drugs and biologic products: invoice price paid by purchaser and wholesale acquisition cost. For each data element, the Contractor shall provide descriptive statistics along with the method of computation.

The Contractor shall 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 percentages) compared to the national coverage by regions (Northeast, Midwest, South, West); and distribution of sales data characteristics by geography, sales volume, type (independent, chain, etc.), and four census regions (see Attachment 4).

The Contractor shall provide the total number of years of data available overall, the number of years available online and accessible in real time to FDA personnel. The lag time between the dates of service for data and on-line availability of the data shall be provided. For historical data that is no longer online, the Contractor shall propose methods to obtain historical data in a timely manner.

1.3.2 Pharmaceutical Sales Data Requirements [International (Global) Sales Data] The contractor shall provide access to data resource(s) sufficient to meet FDA’s need to access global, national-level pharmaceutical sales data, by country. The data resource(s) shall capture sales that occur through all types of distribution arrangements, including wholesalers as well as direct-buy with manufacturers by country where available.

These data resource(s) shall further allow sales data to be broken down by Region (total region), Subregion, Country, Sector (retail and hospital) (where available), and panel type (sell in, sell out) where available. These data resource(s) shall include a minimum of six (6) latest Moving Annual Totals (MATs) of quarterly history. These data shall be provided in quarterly and annual increments for all pharmaceutical products

The drug-specific data elements shall include for all pharmaceutical products contractor has coverage for: Anatomical Therapy Classes (ATC) 2 and 3 attributes, International Product, Local Product Name, Local Pack, Pack (Product name and product pack description, standardized across countries), International Strength (Product strength standardized across countries), Package details: International Pack Size, Volume (Product pack size and product pack volume, standardized across countries), Molecule, Molecule List (Active ingredient, and concatenated list for combination products), Salt (Salts added to the active ingredient), International RX status (Status of product as Rx-bound, or non-Rx-bound), innovations insights (classifies into innovative branded, non-original brand and unbranded), biologics indicator (biologic molecule & product indicator and bio comparable/ biosimilar indicator, non-bio comparable, and Biosimilar Reference Group), Specialty,, NFC123 (Form of the drug in finished dose –full form (oral solid long acting soluble tablets etc.), Sales (# of packs sold expressed in United States Dollars (USD), Euros (EUR) or the Local currency provided the exchange rate to USD is given. Fixed and variable exchange rate), sales volume (shipping packs or units (UN), counting units (CU), standard units (SU) or dose units, KG (Kilogram, International Unit measurement) where available.

The Contractor shall 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 percentages) compared to the US by country.

2. Technical Requirements and Capabilities of the Data Resources

a. The pharmaceutical sales (National/International) data shall be currently existing and commercially available. Access to the data shall be immediate, unlimited, direct, desktop and in real-time. Direct access shall include all upgrades, enhancements, and modifications to software and data.

b. Access shall be through an existing interface and this interface shall be user-friendly, transparent, and flexible enough to meet the FDA’s needs. Minimally, the interface shall provide both predefined (e.g., canned) and custom reports.

c. Full disclosure of data collection, construction, coding and configuration is required to allow FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology.

d. Access to the data resources shall be accessible via a secure Internet or network-based method permitting simultaneous, multi-user access through a user-friendly data query tool(s).

e. The Contractor shall provide the FDA the ability to immediately, directly download data in an automated fashion—without any intervention needed from the Contractor—in the following formats: Microsoft Excel, comma- or tab-separated file, and text delimited file.

The Contractor shall provide the ability to directly download data in both a hierarchical format as well as a flat file (a file where a record contains each user-selected data field). For downloading datasets larger than 100 megabytes, the Contractor shall provide a manner which is compatible with FDA security procedures. The data query tool shall allow the user to download information regarding the user-selected specifications for each query, such as time selected, drugs selected, dosage form selected, and the date that the query was run.

f. The Contractor shall specify any additional software and/or hardware (name and version) necessary to access the data. Any software installed on FDA computers for the purposes of accessing the data shall not use key-logging and/or network capturing functionality to transmit any data from the FDA system except for login information specific to the data and data (e.g., SQL queries or similar methods) accessing the Contractor’s application data sets.

g. The FDA utilizes the virtual private network (VPN) to establish a trusted, encrypted TCP/IP tunnel for accessing data from a remote location. The virtual private network shall be a firewall-to-firewall encrypted tunnel utilizing commercially available software and industry standard IPSEC protocols. The Contractor shall conform to Section 508 standards. (See Section

h. The data resource(s) shall be accessible via secure Internet or network-based or cloud methods permitting simultaneous, multi-user access through user-friendly data query tool(s) and Application Programming Interface(s) (API) as determined in collaboration with the contractor. The network-based methods shall not necessitate any additions to the FDA communications infrastructure. Preferred methods for access (in order of preference) are:

1) secure Internet access, and 2) firewall-to-firewall virtual private network (VPN). FDA shall not support modem-based or dial-up access.

i. The Contractor shall provide the FDA with 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). These data shall be available in machine-readable formats as described in bullet

(e) above. FDA requires unrestricted access to datasets which shall be available on demand and without intervention by the Contractor through its interface. FDA shall retain the ability to incorporate these data into other information technology products for internal use with vendor collaboration.

j. In the event of changes to the Contractor’s business or agreements with their data suppliers, the FDA shall be notified within 5 business days of the Contractor becoming aware of such changes. This notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics.

3. Custom programming and analytical support (ad-hoc hours)

The Contractor shall provide additional analytical and programming support, to enable FDA personnel to obtain other sales metrics not available through the online data tools. The FDA estimates a potential need of up to 200 ad-hoc hours annually. The Contractor may need to provide additional hours of ad-hoc data analyses, custom queries, or raw data preparation not available through the data tools and in increments to be determined at the Task Order level.

4. Onsite Training Programs and Training Materials

The Contractor shall provide training for users of the data, as well as training for FDA personnel who shall support use of the data (e.g., technical users). The contractor shall provide a minimum of two onsite or virtual training sessions per year. Live or web-based training of FDA personnel shall be required for any modifications, enhancements, or upgrades to the data source.

The Contractor shall provide course outlines for all levels of training offered and options for additional “on-demand” sessions either in person or via web-based methods. The training shall be initiated within 30 days of award and continue throughout the duration of contract.

5. Onsite Kick-Off and Annual Meetings

The Contractor shall participate in a kick-off meeting within two weeks of award and shall conduct an annual meeting virtual or on-site at the FDA campus in Silver Spring, MD. The purpose of the annual meeting is to discuss scientific issues of interest to the Agency and relevant work that the contractor has performed, as well as discussing FDA satisfaction with all deliverables.

6. Technical Support

The Contractor shall provide a support package comprised of written documentation that includes technical, analytical, and clinical support throughout the length of the contract. The support package shall include any modifications, enhancements, or upgrades to the data source.

The Contractor shall provide ongoing technical, analytical, and clinical support by phone or by e-mail for all certified users of the data during business hours (9:00 am to 5:00 pm, EST) throughout the length of the contract in accordance with the service levels established in the contract.

To ensure effective communication and access to needed resources, the contractor shall have dedicated client support personnel to serve as a liaison between the FDA and the contractor.

7. Disclosure Clearance for Aggregated Data outside the Agency

As part of its regulatory activities, FDA shall, at times, require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public. For activities that require disclosure of aggregated data the Contractor shall accept and adhere to the FDA Data Disclosure Clearance Procedures and Form found in Attachments 5 and 6 unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA. The FDA shall continue to require the ability to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the contract period of performance. After ordering period year 2, the FDA shall notify the contractor of the aggregated data release and accept the Contractor’s requested revisions but shall not require formal approval for release.

7.1 Clearance for Third Party Collaborations:

As part of its regulatory activities, FDA shall, at times engage in collaborative research projects with third parties outside of FDA for specific research projects of public health importance that are initiated by and for the benefit of FDA. These collaborations shall require FDA to have the ability to share project specific aggregated or raw data with third parties for collaborative research projects. For these collaborations that require sharing of aggregated or raw data, the Contractor shall accept and adhere to the Data Disclosure Clearance Procedures and form to be found in Attachments 5 and 6 unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA.

These Procedures include terms and conditions for third party collaborations.

7.2 Clearance after Conclusion of Contract:

The FDA shall continue to require, after the conclusion of the contract, the ability to release aggregated data through the FDA Data Disclosure Clearance process for data obtained for analyses during the contract period. After Option Year 4,Year 5 the FDA shall notify the Contractor of the aggregated data release and accept the Contractor’s requested revisions but shall not require formal approval for release.

8. Ad-Hoc Technical Services

The Contractor shall provide unlimited additional quantities of Services via the issuance of firm fixed priced, time and materials, or hybrid Task Orders. These technical directive orders shall be billed in accordance with the over-arching labor rates agreed upon in the pricing schedule.

The type of additional services and associated maintenance would include:

a) Customized analysis – Analysis of National Pharmaceutical Sales Data that endeavors to answer a specific question that requires additional tools beyond the current interface tool (e.g., includes fields not provided in the tool but that are available in the database).

b) Training services – Additional ad-hoc training services as needed

c) Medical devices sales data

d) International sales data

e) Granular sales data (e.g., geography- State, county, zip3; increased frequency- e.g., weekly, daily etc.)

f) Ad-Hoc Analyses – The Contractor shall provide additional hours of ad-hoc analyses or custom queries not available through the data tool. For example, confidence intervals around point estimates, and raw (unprojected) data.

9. Trial Subscription Period

The FDA requires a 30-day trial subscription. The trial subscription shall include direct access, documentation, and technical support for a maximum of seven FDA researchers on the technical evaluation panel. The FDA will not pay for this subscription as access will be used solely to evaluate the Offeror’s product, and not for any analysis, public disclosure or regulatory decision making.

The Offeror shall provide telephonic or web-based training session that lasts a maximum of 2 hours at the start of the trial subscription period. Trial subscription shall include online access (user names and passwords).

The Offeror’s proposal shall include a point of contact for FDA to call to set up the trial subscription and the Trial Subscription Agreement.

The FDA shall only use the data for the purposes of understanding the systems data resources. FDA shall not use the data, nor any analyses derived from the data, for public disclosure or regulatory decision-making.

910. Performance Evaluation Plan

Performance shall be evaluated by the FDA to determine whether it meets the threshold of the agreement. When the performance threshold is not met, the FDA Contracting Officers Representative (COR) shall notify the Contract Specialist/Officer. The Contractor shall reply to all performance inquiries listed below with a resolution within 15 business days of receipt. Failure to meet the Acceptable Quality Level shall be captured as non-performance and provided to the Contracting Officer for action.

Required Service Standard Acceptable Quality Level (AQL)

Method of Surveillance

The Contractor shall provide Disclosure Clearance and Third-Party Agreement Service

The turnaround time for urgent clearance requests is 24 hours; 48 hours for standard clearance requests;

and 72 hours for third-party agreements

Standard shall be fully met at 100%

COR and FDA staff shall maintain a clearance tracking log with turnaround times

The Contractor shall provide Unlimited Direct Access to Data Resource and Services

The Contractor shall notify the FDA 48 hours in advance of any circumstances resulting in loss of access to the data source due to planned downtime The Contractor shall notify the FDA within 30 minutes (Monday- Friday, 9:00 AM – 5:00 PM Eastern Time) from the onset of unplanned downtime with an estimate of time as to restoration of access

Standard shall be fully met at 100%

COR and FDA staff shall monitor database access, notification and restoration times

The Contractor shall provide Ad-hoc Analyses: custom reporting and

The Contractor shall provide the FDA ad-hoc data results within 15 business

Standard shall be fully met at 100%

COR and FDA staff shall monitor turnaround times

Required Service Standard Acceptable Quality Level (AQL)

Method of Surveillance product customization days from receipt of request from FDA, or a mutually agreed upon delivery timeline (for more complex analyses) from the Contractor’s monthly report

The contractor shall provide a resolution plan and shall include a timeline for resolving any circumstances resulting in loss of, or lack of, access to data or any data errors/loss from the database(s)

Within five business days of Contractor’s knowledge of the loss or lack of access to data or any data errors/loss from the database(s) and shall be documented in the Monthly Progress Report

Standard shall be fully met at 100%

COR and staff review of data quality (i.e., variance in data runs)

The Contractor shall guarantee timely access to pharmaceutical sales data

The mutually agreed upon dataset parameters (max.

size, data elements) and turnaround time to be negotiated at the time of award

Standards shall be fully met for access to all prescription-and patient-analytical datasets

COR and staff review of dataset quality and turnaround times

101. ANTICIPATED DELIVERABLES

. Below represent known, recurring deliverables expected to be required in the contract.

101.1 Quality Control/Project Management Plan

The Contractor shall provide a Quality Control Plan (QCP) plan detailing procedures and guidelines to ensure the required performance standards or services levels are met throughout the life of this contract. The QCP shall describe the systematic methods used to monitor performance, identify required documentation, and allocate resources. The Government reserves the right to alter or change the surveillance methods in the QCP at its own discretion. In addition to the QCP, a Project Management Plan (PMP) should be provided.

101.2 Monthly Usage Reports

The Contractor shall provide Monthly Usage Reports by the 20th of each month for the previous month data detailing use of the resource by individual FDA users and type of use clearances, third party agreements, number of ad-hoc programming hours used and project title (See Attachment 6 - Example of Monthly Usage Report).

a. The Monthly Usage Report shall include the number and type of data queries by individual

FDA user.

b. Clearance Requests shall include type of data submitted, project title, FDA requestor, date of request, and approval date.

c. Third Party Agreement Requests shall include third party collaborator, project title, FDA principal investigator, date of request, approval date, and expiration date.

d. Ad-hoc Dataset Requests shall include the number of technical support programming hours used, project title, FDA requestor, date of request, and date received.

e. Notifications of any circumstances resulting in loss or lack of data streams, or any data enhancements or data errors that would impact access to data from the data resource(s).

101.3 Progress Reports - The Contractor shall submit one (1) electronic copy of the Progress Report monthly to the COR and Contracts Specialist. The report shall include a status update on each task worked on and deliverables submitted, any problems encountered, and suggestions for addressing problems each period. If the tasks are cost reimbursable in nature, an accounting of applicable staff who worked on the tasks as well as any deviations from the original projection of hours planned vs.

actually incurred shall be required.

112 Deliverable Table

BASE YEAR (Deliverable Items)

Item No. Description of Supplies/Service Quantity Unit Delivery Date

0001 Kick Off/On-site Annual Meeting NSP Annual Initiated within 2 week of award

0002 Onsite Training Programs and Training Materials

NSP Bi- Annually

Initiated within 30 days after award and updated as needed thereafter.

0004 Quality Control Plan NSP Monthly Initiated at time of award and updated as needed

0005 Program Management Plan NSP Annual Initiated at time of award and updated as needed thereafter.

123. ADVANCE UNDERSTANDING

Notwithstanding any of the above requirements, under certain circumstances, the Government may be required to share data or information it obtains under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction. If it intends to share data or information obtained under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction, the Government shall take appropriate measures within its control to ensure that the information shall be shared in a manner intended to protect the information from public disclosure.

The Contractor shall ensure the protection of the information and data they receive under this contract from unauthorized use or disclosure and shall treat the information as confidential or otherwise privileged.

0006 Monthly Usage Reports

NSP Monthly Due by the 20th of each month for the previous month data

0005 Progress Report NSP Monthly Provide monthly to COR/Contract Specialist