Data Resource for Post-marketing Surveillance of Nonmedical Use of Pharmaceuticals and Use of Illicit Drug Substances

Document Type: Notice of Intent to Sole Source Solicitation Number: FDA - NOI - 1243229 Posted Date: 8/13/2021 Response Date: 8/27/2021 NAICS Code: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) The Food and Drug Administration intends to award two sole source contracts for research and development projects to obtain post-marketing data on Non-medical Use (NMU) of prescription and over-the-counter drugs and use of illegal substances from 1) individuals entering or being assessed for substance abuse treatment; and, 2) other available data sources providing information on NMU of pharmaceutical products and illegal drug use, for example, internet and social media postings, internet panel-based surveys, and data on drug diversion and counterfeit pharmaceuticals. The awards will be made to: Integrated Behavioral Health, Inc. 3070 Bristol Street, Suite 350 Costa Mesa, CA 92626 Denver Health and Hospital Authority 777 Bannock Street Denver, CO 80204 In accordance with FAR 6.302-1 the solicitation contains circumstances permitting other than full and open competition. This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within 15 days after the publication of this synopsis which shall be considered by the agency. Responses received after 15 days or without the required information may not be considered. For information concerning this proposed acquisition contact: Kimberly DeLong, kimberly.delong@fda.hhs.gov. The purpose of this requirement is to establish the next 5-year Multiple Award Indefinite Delivery, Indefinite Quantity (IDIQ) contract to obtain data reports on NMU of prescription and over-the-counter drug products and illegal drugs for the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE). In turn, OSE will use the reports to help inform pharmaceutical regulatory and oversight efforts, and NMU prevention programs. FDA is tasked with acquiring, assessing, and responding to post-marketing epidemiologic data related to the NMU of pharmaceutical products with central nervous system activity. These include opioids, benzodiazepines, stimulants, and other drug classes. Due to the high prevalence of polysubstance use and the inter-related nature of pharmaceutical and illegal substance use, it is also critical for FDA to monitor trends and patterns of illegal substance use and associated harms. Non-medical use of drugs presents unique challenges, and typical pharmacoepidemiologic data sources and study designs are generally not sufficient to address all regulatory questions. Therefore, non- traditional data sources and methods must be employed. No single data source can capture all the abuse-related outcomes of interest, or all individuals at-risk for these outcomes. Data collected from individuals entering NMU treatment centers to be assessed for treatment of substance use disorders is one source of valuable information on the abuse of individual pharmaceutical products as well as overall patterns and trends in prescription drug abuse in the United States. These types of data sources are one of many sources that provide a compendium of data that provide the information needed for making regulatory decisions. In 2016, FDA entered into a 5-year Multiple Award IDIQ contract to provide post-marketing prescription and over-the-counter drug abuse surveillance data summary reports and analytical datasets generated from aggregated data from individuals entering or being assessed for substance abuse treatment, i.e., treatment center data. These contracts provided surveillance data via biannual surveillance data reports and allowed FDA to obtain ad hoc data reports to study the impact of rescheduling actions and to inform discussion at multiple public advisory committee meetings. As a result of FDA's continued use of these data reports and the recognized limitations of the data, FDA sought to improve the existing data resources to better meet FDA's data needs for regulating opioids and other products with abuse potential. In alignment with this effort in 2017, FDA issued Data Verification Projects Task Orders. The objectives of these Task Orders were (1) to gain a better understanding of the representativeness of their sources of data: (2) to explore the feasibility of and potential strategies for obtaining a mutually agreed upon national probability sample derived from a well-defined underlying population, (3) to assess the extent and characteristics of misclassification in data sources, and (4) to develop approaches for improved ascertainment and analytic approaches that address existing misclassification. Building on these efforts, in 2019 FDA issued another task order titled, - Improving the Quality and Representativeness of the Treatment Center Program Data. The goal of this project was to use the information gathered in the Data Verification Project to address identified sources of sampling bias and misclassification to improve the overall utility of these data for FDA's regulatory needs. A similar task order was awarded titled, "Improving the Quality and Representativeness of the Addiction Severity Index-Multimedia Version (ASI-MV) Network". The overarching objective of this task order was to use the information gathered in the Data Verification Project to improve the quality and representativeness of the ASI-MV data to enhance their utility for FDA regulatory needs. The information obtained through these contracts have been invaluable to the Agency and include: - Information accessed from populations enriched with individuals with more advanced substance use disorders and a high prevalence of non-oral drug use and polysubstance use - Detailed data on the recent drugs these individuals report using, including data on formulation and dosage form, route of administration, and geographic and demographic distribution. - Information has supported regulatory work related to the safety and effectiveness of abuse-deterrent formulation opioid analgesics and have been the basis of reviews and briefing documents to inform advisory committee members and review divisions considerations of the public health impact of controlled substances regulated by the Agency Although these data continue to be useful, the Agency's needs have evolved to include supplemental data as follows: - General population surveys (e.g., internet panel surveys) of nonmedical substance use, drug diversion case reports, crowd-sourced street price data, analyses of internet discussion posts (e.g., blogs, social media), and targeted follow-up of individuals entering or being assessed for substance use disorder treatment. - Longitudinal follow-up data in the area of substance use disorders, as the currently available data sources and scientific literature are largely lacking in this area. We are interested in better understanding the natural history, or trajectory, of substance use disorders, and the role of treatment and other interventions in an individual's course. - Other types of survey data (e.g., internet panel survey data, qualitative analyses of web postings, and other types of nontraditional data (e.g., data on drug diversion cases or street price) can provide value for certain types of regulatory questions.