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The Comprehensive Addiction and Recovery Act of 2016 (S. 524): Comparison of Senate- and House-Passed Versions

Description: This report discusses selected differences and similarities between the Senate- and House-passed versions of the Comprehensive Addiction and Recovery Act of 2016 (CARA; S. 524), which aims to address the problem of opioid addiction in the United States. The two versions of the bill differ substantially. The scope of the differences may be illustrated by their structures: The Senate bill has 28 sections organized in 8 titles, whereas the House bill has 69 sections organized in 18 titles.
Date: May 23, 2016
Creator: Bagalman, Erin & Sacco, Lisa N.
Partner: UNT Libraries Government Documents Department
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Legal Authorities Under the Controlled Substances Act to Combat the Opioid Crisis

Description: This report discusses legal authorities available to the federal government under the Controlled Substances Act (CSA) that could be used to combat the opioid epidemic. The report then examines DEA initiatives and actions taken, pursuant to its legal authorities under the CSA, which specifically target the abuse of opioids. It concludes by discussing selected opioid-related legislative proposals in the 115th Congress that would amend the CSA.
Date: April 16, 2018
Creator: Yeh, Brian T.
Partner: UNT Libraries Government Documents Department
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Responding to the Opioid Epidemic: Legal Developments and FDA's Role

Description: This report discusses the opioid epidemic in the U.S. and the role of the Federal Food and Drug Administration (FDA) in helping end the epidemic. The report provides an overview of FDA's existing authorities, the historical context for the opioid epidemic, and the agency's current plan for combatting the opioid epidemic, concluding with an examination of the broader legal questions concerning the crisis.
Date: March 6, 2018
Creator: Armstrong, Kathryn B.
Partner: UNT Libraries Government Documents Department
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FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development

Description: This report provides a brief history of FDA drug regulation, describes FDA's early risk management programs, and focuses on the agency's current risk management authorities, specifically risk evaluation and mitigation strategies (REMS). The report also discusses issues that have arisen as a result of REMS, particularly the impact on generic drug competition. While this report generally focuses on REMS in the context of generic drug development, the issues discussed are also relevant to biologic… more
Date: March 16, 2018
Creator: Dabrowska, Agata
Partner: UNT Libraries Government Documents Department
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State Legalization of Recreational Marijuana: Selected Legal Issues

Description: This report summarizes the Washington and Colorado marijuana legalization laws and evaluates whether, or the extent to which, they may be preempted by the Controlled Substances Act (CSA) or by international agreements. It also highlights potential responses to these recent legalization initiatives by the U.S. Department of Justice (DOJ) and identifies other noncriminal consequences that marijuana users may face under federal law.
Date: April 5, 2013
Creator: Garvey, Todd & Yeh, Brian T.
Partner: UNT Libraries Government Documents Department
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Governmental Drug Testing Programs: Legal and Constitutional Developments

Description: This report examines the current state of constitutional law on the subject of governmentally mandated drug testing in employment and of students in the public schools, which is followed by a brief review of federal drug-free workplace programs presently in effect.
Date: August 19, 2008
Creator: Carpenter, David H.
Partner: UNT Libraries Government Documents Department
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State Legalization of Recreational Marijuana: Selected Legal Issues

Description: This report summarizes the Washington and Colorado marijuana legalization laws and evaluates whether, or the extent to which, they may be preempted by the Controlled Substances Act (CSA) or by international agreements. It also describes and analyzes the U.S. Department of Justice's (DOJ's) response to these legalization initiatives. The report then identifies certain noncriminal consequences that marijuana users may face under federal law. Finally, the report closes with a description of select… more
Date: January 13, 2014
Creator: Garvey, Todd & Yeh, Brian T.
Partner: UNT Libraries Government Documents Department
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Drug Enforcement in the United States: History, Policy, and Trends

Description: This report reviews federal domestic drug enforcement. First, it provides a history and background of drug enforcement in the United States including how drugs came under the control of federal justice authorities and how legislation and administrative actions changed domestic drug enforcement. It then provides a brief overview of drug enforcement in the United States and summarizes U.S. drug policy. Finally, the report presents trends in federal drug enforcement and concludes with a discussion… more
Date: October 2, 2014
Creator: Sacco, Lisa N.
Partner: UNT Libraries Government Documents Department
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Regulatory Exclusivity Reform in the 115th Congress

Description: This report introduces the various regulatory exclusivities that protect certain medicines from marketplace competition for a set period of time and then describes pertinent legislation in the 115th Congress addressing them.
Date: September 15, 2017
Creator: Thomas, John R.
Partner: UNT Libraries Government Documents Department
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FDA Human Medical Product User Fee Programs: In Brief

Description: This report discusses FDA human medical product user fees for prescription drugs, medical devices, generic drugs, and biosimilars which are charged to companies producing the products and make up a large portion of the FDA's revenues. User fees are authorized in legislation on a five-year cycle, with authority for their actual collection and expenditure provided each year through the annual appropriations process. Appendix A outlines various features of the user fee programs.
Date: November 21, 2017
Creator: Dabrowska, Agata; Johnson, Judith A.; Sarata, Amanda K. & Thaul, Susan
Partner: UNT Libraries Government Documents Department
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FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

Description: The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, … more
Date: December 2, 2008
Creator: Thaul, Susan
Partner: UNT Libraries Government Documents Department
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Drug Testing and Crime-Related Restrictions in TANF, SNAP, and Housing Assistance

Description: This report describes and compares the drug- and crime-related policy restrictions contained in selected federal programs that provide assistance to low-income individuals and families: the Temporary Assistance for Needy Families (TANF) block grant, the Supplemental Nutrition Assistance Program (SNAP, formerly Food Stamps), and the three primary federal housing assistance programs (the public housing program, the Section 8 Housing Choice Voucher program, and the project-based Section 8 rental a… more
Date: August 28, 2015
Creator: McCarty, Maggie; Falk, Gene; Aussenberg, Randy A. & Carpenter, David H.
Partner: UNT Libraries Government Documents Department
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International Drug Control Policy: Background and U.S. Responses

Description: This report discusses challenges created by the global illegal drug trade, including: undermining political and regional stability, bolstering the role and capabilities of transnational criminal organizations in the drug trade, and the burden caused by drug use an addition on local communities and economic development. In addition, this report discusses U.S. policy efforts to thwart illegal drug trade.
Date: October 16, 2012
Creator: Wyler, Liana Sun
Partner: UNT Libraries Government Documents Department
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Federal Taxation of the Drug Industry and Its Effects on New Drug Development

Description: This report examines the impact of federal taxation on the incentive to invest in new drug development. More specifically, it looks at the provisions in current tax law that affect the performance of the drug industry, compares the industry's federal tax burden with that of other major industries, and assesses the effect of federal taxation on the incentive to invest in new drug development.
Date: March 18, 2009
Creator: Guenther, Gary
Partner: UNT Libraries Government Documents Department
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Ecstasy: Actions of the 107th Congress to Control MDMA

Description: Legislation has been proposed in the 107th Congress to combat the use and abuse of Ecstasy (MDMA) and other “club drugs.” In a 2001 survey, 12% of 12th graders reported ever having taken the drug. The Ecstasy Anti-Proliferation Act of 2000, enacted by the 106th Congress, directed the U.S. Sentencing Commission to increase penalties for Ecstasy offenses. As of March 2001, MDMA penalties became more severe than for powder cocaine but less severe than for heroin.
Date: July 5, 2002
Creator: Eddy, Mark
Partner: UNT Libraries Government Documents Department
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Ecstasy: Actions of the 107th Congress to Control MDMA

Description: Legislation has been proposed in the 107th Congress to combat the use and abuse of Ecstasy (MDMA) and other “club drugs.” In a 2001 survey, 12% of 12th graders reported ever having taken the drug. The Ecstasy Anti-Proliferation Act of 2000, enacted by the 106th Congress, directed the U.S. Sentencing Commission to increase penalties for Ecstasy offenses. As of March 2001, MDMA penalties became more severe than for powder cocaine but less severe than for heroin.
Date: August 14, 2002
Creator: Eddy, Mark
Partner: UNT Libraries Government Documents Department
open access

Ecstasy: Actions of the 107th Congress to Control MDMA

Description: Legislation has been proposed in the 107th Congress to combat the use and abuse of Ecstasy (MDMA) and other “club drugs.” In a 2001 survey, 12% of 12th graders reported ever having taken the drug. The Ecstasy Anti-Proliferation Act of 2000, enacted by the 106th Congress, directed the U.S. Sentencing Commission to increase penalties for Ecstasy offenses. As of March 2001, MDMA penalties became more severe than for powder cocaine but less severe than for heroin.
Date: October 31, 2002
Creator: Eddy, Mark
Partner: UNT Libraries Government Documents Department
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