Prescription drug abuse has been described as an epidemic, with an estimated 6.5 million current prescription drug abusers—including 4.3 million abusing prescription pain relievers (opioids). On average, 44 people die from an overdose of a prescription painkiller each day in the United States. While prescription painkillers are not the only prescription drugs of abuse (see text box), they are the most commonly abused and receive the most attention from federal policymakers. Federal policy on PCS aims to balance the need to limit abuse of prescription controlled substances (PCS) with the need to maintain access to PCS for legitimate medical use. The federal government's approach to addressing prescription drug abuse has increasingly relied on coordination across agencies, including both law enforcement and health agencies. This report begins with a summary of recent efforts to address prescription drug abuse—focused on prescription painkiller abuse. The remainder of the report is organized in two parts: (1) federal roles in reducing prescription drug abuse and (2) current approaches aimed at reducing prescription drug abuse. Federal roles include coordination across agencies; regulation of drugs; law enforcement activities; and health services, financing, and research. Approaches to reducing prescription drug abuse include scheduling of PCS; safe storage and disposal; focusing law enforcement; using data to identify risk; awareness and education; and treatment. Congress has demonstrated an interest in addressing the problem of prescription drug abuse (and particularly prescription opioid abuse) by holding hearings and introducing legislation taking various approaches to the problem. For example, the Comprehensive Addiction and Recovery Act of 2015 ( H.R. 953 , S. 524 ) would primarily authorize the Department of Health and Human Services (HHS), the Department of Justice (DOJ), and the White House Office of National Drug Control Policy (ONDCP) to administer grants and require HHS to convene task forces. In contrast, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015 ( H.R. 471 , S. 483 ) would primarily amend current law regarding registration to distribute or dispense PCS and require an inter-departmental report to Congress. The Administration has also made efforts to address the problem, including an HHS opioid initiative and a Presidential Memorandum requiring federal agencies to provide training in opioid prescribing to employees who prescribe controlled substances and to identify and address barriers to accessing medication-assisted treatment for opioid addiction. Both Congress and the Administration have directed funds toward reducing opioid abuse and overdoses. The Consolidated Appropriations Act, 2016 ( P.L. 114-113 ) includes some funding for opioid-specific programs, most of which is identified in the explanatory statement accompanying the act. For example, the agreement provides $25 million for the Substance Abuse and Mental Health Services Administration (SAMHSA) to expand prescription opioid and heroin abuse treatment services in high-risk communities. The President's Budget for FY2017 proposes both mandatory and discretionary funding for HHS to address prescription opioid and heroin abuse, with an emphasis on expanding the use of medication-assisted treatment. The federal government works to reduce prescription drug abuse in a variety of roles, including coordination across agencies; regulation of drugs; law enforcement activities; and health services, financing, and research. This section provides an overview of these roles, along with references to other CRS reports that address some of these roles in more detail. Multiple federal agencies participate in the mission to reduce prescription drug abuse—the White House Office of National Drug Control Policy (ONDCP) coordinates and tracks these agencies' efforts and related federal funding. In its 2014 National Drug Control Strategy (the Strategy), ONDCP identifies three policy priorities where the Administration believes there can be substantial progress over the short term; these priorities include reducing prescription drug abuse. In its prescription drug abuse prevention plan, Epidemic: Responding to America's Prescription Drug Abuse Crisis (published in 2011), ONDCP outlined how the federal government intends to address prescription drug abuse. The plan expanded upon the Strategy's action items that specifically addressed demand reduction. Some action items included additional training and education for physicians and pharmacists, improved drug disposal programs, enhanced prescription drug monitoring programs (PDMPs), and improved cooperation and information sharing among PDMPs. Coordinated efforts involve (1) educating parents, youth, patients, and health care providers; (2) tracking and monitoring of prescribing activity; (3) developing prescription drug disposal regulations and programs; and (4) taking enforcement action against pain clinics and prescribers who improperly prescribe and dispense narcotics. A number of federal agencies are directly involved in these efforts, including the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA); in addition, the federal government financially supports some state prescription drug abuse prevention efforts. State efforts include the operation of prescription drug monitoring programs and participation in drug task forces. The primary federal statutes governing the regulation of prescription drugs are the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Comprehensive Drug Abuse Prevention and Control Act of 1970, commonly referred to as the Controlled Substances Act (CSA). The FFDCA gives the Food and Drug Administration (FDA) responsibility for ensuring the safety and effectiveness of prescription and nonprescription drugs sold in the United States, among other things. An agency within the Department of Health and Human Services (HHS), FDA regulates the full life-cycle of a drug product, starting with initial clinical trials (and sometimes before that), through the approval process, and then for as long as the product remains on the U.S. market. FDA activities that apply to all drugs—such as drug approval, labeling, and postapproval surveillance—can be tailored to the challenges of regulating PCS, where the risk of addiction may pose a safety concern. Other FDA activities—namely the work of the Controlled Substances Staff—are focused specifically on curbing prescription drug abuse. (See text box.) FDA reviews each new drug application submitted by a drug manufacturer with three major concerns: (1) safety and effectiveness in the drug's proposed use; (2) appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to ensure the drug's identity, strength, quality, and purity. Reviewers can consider abuse potential (and possibly deterrence characteristics) within any of these elements. FDA approval of a drug for marketing may include specific conditions, such as restrictions on distribution, labeling disclosures, or postapproval studies that the manufacturer must conduct after marketing begins. FDA may require a risk evaluation and mitigation strategy (REMS) under specified conditions—including if it determines such a strategy is necessary to ensure that the benefits of a drug (e.g., pain relief) outweigh its risks (e.g., potential for abuse). A REMS may include drug safety information for patients and health care providers, as well as elements to assure safe use (ETASU). An ETASU is a restriction on distribution or use that is intended to (1) allow access to those who could benefit from the drug while minimizing their risk of adverse events, and (2) block access to those for whom the potential harm would outweigh potential benefit. By including these restrictions, FDA can approve a drug that it otherwise would have to keep off the market because of the risk it would pose. As part of the approval process, FDA reviews the manufacturer's labeling, which must begin with a highlights section that includes, if appropriate, black-box warnings (so called because they are bordered in black to signify their importance). Regulations specify other required elements of labeling, including risk of drug abuse and dependence. The Food and Drug Administration Amendments Act of 2007 (FDAAA) added authority for the agency to require a labeling change upon learning of new relevant safety information. In September 2013, FDA announced that it would use that new authority to require changes to the labeling of extended-release and long-acting opioids used to treat pain. FDA postmarket drug safety and effectiveness activities address aspects of drug production, distribution, and use. In addition to REMS and labeling requirements, FDA addresses product integrity and supply chain security, adverse event reporting, surveillance (including the Sentinel program), information dissemination, off-label use, direct-to-consumer advertising, and postmarket studies. The Secretary may require a study or a clinical trial involving a drug that is already on the market based on newly available information. In September 2013, FDA announced several studies it was directing the manufacturers of extended-release or long-acting opioid analgesic drugs to conduct. FDA has a task force focused on combatting abuse of opioid pain relievers at various points throughout the drug life cycle described above. (See text box.) In February 2016, FDA announced an opioids action plan, under which the agency will expand the use of expert advisory committees regarding approval of opioid products that do not have abuse-deterrent properties and pediatric opioid labeling; change labeling for immediate-release opioids; increasing manufacturers' postmarket data requirements; update an existing REMS; issue draft guidance on approval standards for general abuse-deterrent formulations; review options to increase access to naloxone (a drug that can reverse opioid overdose), support opioid prescribing guidelines, and "facilitate development of evidence and improved treatments;" and reassess the current risk-benefit framework for approval of opioids to incorporate public health effects of misuse. For more information about FDA's role in drug safety and effectiveness—not limited to PCS—see CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness , by [author name scrubbed]. The CSA is designed to regulate and facilitate the use of controlled substances for legitimate medical, scientific, research, and industrial purposes and to prevent these substances from being diverted for illegal purposes. Most prescription drugs are not controlled substances and therefore are not regulated under the CSA .