Addiction Prevention and Responsible Opioid Practices Act
Legislative Progress
Momentum (last 30 days)
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vs 3,548 other S bills in the 114th — cohort avg 43d
Addiction Prevention and Responsible Opioid Practices Act This bill addresses prescription opioid misuse. The Food and Drug Administration (FDA) must: (1) seek recommendations concerning opioid drugs from an FDA advisory committee relating to the approval of a new drug that is an opioid, and the labeling of opioid drugs for pediatric prescriptions; (2) develop recommendations for education programs for prescribers of opioids; and (3) issue guidance for labeling that deters opioid abuse. The bill amends the Federal Food, Drug, and Cosmetic Act by requiring manufacturers of opioid drugs to ensure that certain information about the risk factors associated with opioid drugs are included on the drug labels. The bill amends the Controlled Substances Act by: (1) addressing annual narcotic manufacturing quotas with respect to fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone; and (2) directing the Department of Justice (DOJ) to require medical practitioners to complete a training program on prescribing opioids for chronic pain before they are certified to prescribe controlled substances in schedule II, III, or IV. The bill establishes requirements for prescription drug monitoring systems to prevent over-prescribing controlled substances. The Department of Health and Human Services must: (1) submit a plan of action for addressing outliers in opioid prescribing practices and ensuring an adequate response to protect the public health, and (2) study the expansion of Medicare coverage for alternatives to opioid treatments. The bill amends the Internal Revenue Code to impose an excise tax on manufacturers or producers of opioid pain relievers. A portion of the amount generated from the tax must be used for substance abuse treatment programs. DOJ must establish a take-back program for the safe and environmentally responsible disposal of controlled substances.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (6)
2016 · third_quarter · Taxation/Internal Revenue Code
Read twice and referred to the Committee on Finance. (text of measure as introduced: CR S4301-4303)
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Taxation Issues Related to Opioid Pharmaceuticals. S.3075: Addiction Prevention and Responsible Opioid Practices Act. S.2977: Budgeting for Opioid Addiction Treatment Act.
Client expense: $570,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Taxation/Internal Revenue Code
Taxation Issues Related to Opioid Pharmaceuticals. S.3075: Addiction Prevention and Responsible Opioid Practices Act. S.2977: Budgeting for Opioid Addiction Treatment Act.
Client expense: $800,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · third_quarter · Taxation/Internal Revenue Code
Taxation Issues Related to Opioid Pharmaceuticals. S.3075: Addiction Prevention and Responsible Opioid Practices Act. S.2977: Budgeting for Opioid Addiction Treatment Act.
Client expense: $569,598 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Pharmacy
Legislation and policies relating to: H.R. 471/S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act H.R. 639 - Improving Regulatory Transparency for New Medical Therapies Act H.R. 953/S. 524 - Comprehensive Addiction and Recovery Act of 2015 H.R. 2536/S. 1455 - Recovery Enhancement for Addiction Treatment (TREAT) Act H.R. 4435 - Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R. 4843 - Infant Plan of Safe Care Improvement Act H.R. 4978 - NAS Healthy Babies Act H.R. 4981 - Opioid Use Disorder Treatment Expansion and Modernization Act H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 H.R. 5052 - Opioid Program Evaluation Act S. 1392 - Safe Prescribing of Controlled Substances Act S. 2423 - A bill making appropriations to address the heroin and opioid drug abuse epidemic for the fiscal year ending September 30, 2016, and for other purposes S. 3075 - Addiction Prevention and Responsible Opioid Practices Act S. 3223 - Expanded Access to Treatment and Recovery Act
Client expense: Not reported · Firm income: $23,450
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2016 · fourth_quarter · Alcohol and Drug Abuse
H.R. 471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524 - Comprehensive Addiction and Recovery Act of 2016 H.R.953 - Comprehensive Addiction and Recovery Act of 2015 HR 3250 - DXM Abuse Prevention Act S. 2294 - DXM Abuse Prevention Act H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 H.R.4931 - Pharmaceutical Stewardship Act of 2016 S. 3075 - Addiction Prevention and Responsible Opioid Practices Act
Client expense: $380,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Alcohol and Drug Abuse
Support efforts to address prescription drug abuse and heroin overdose epidemic, including funding. Support S. 524, the Comprehensive Addiction and Recovery Act. Support S. 3075, the Addiction Prevention and Responsible Opioid Practices Act.
Client expense: $34,832 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, White House Office
2016 · third_quarter · Taxation/Internal Revenue Code
Taxation Issues Related to Opioid Pharmaceuticals. S.3075: Addiction Prevention and Responsible Opioid Practices Act. S.2977: Budgeting for Opioid Addiction Treatment Act.
Client expense: $569,598 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Client expense: $285,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Program Support Center, SENATE, U.S. Trade Representative (USTR), White House Office
2016 · third_quarter · Health Issues
Issues related to epinephrine auto-injectors pricing Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Client expense: $345,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Program Support Center, SENATE, U.S. Trade Representative (USTR), White House Office
2016 · third_quarter · Pharmacy
Legislation and policies relating to: H.R. 471/S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act H.R. 639 - Improving Regulatory Transparency for New Medical Therapies Act H.R. 953/S. 524 - Comprehensive Addiction and Recovery Act of 2015 H.R. 2536/S. 1455 - Recovery Enhancement for Addiction Treatment (TREAT) Act H.R. 4435 - Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R. 4843 - Infant Plan of Safe Care Improvement Act H.R. 4978 - NAS Healthy Babies Act H.R. 4981 - Opioid Use Disorder Treatment Expansion and Modernization Act H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 H.R. 5052 - Opioid Program Evaluation Act S. 1392 - Safe Prescribing of Controlled Substances Act S. 2423 - A bill making appropriations to address the heroin and opioid drug abuse epidemic for the fiscal year ending September 30, 2016, and for other purposes S. 3075 - Addiction Prevention and Responsible Opioid Practices Act S. 3223 - Expanded Access to Treatment and Recovery Act
Client expense: Not reported · Firm income: $23,450
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2016 · third_quarter · Alcohol and Drug Abuse
H.R. 471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524 - Comprehensive Addiction and Recovery Act of 2016 H.R.953 - Comprehensive Addiction and Recovery Act of 2015 HR 3250 - DXM Abuse Prevention Act S. 2294 - DXM Abuse Prevention Act H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 H.R.4931 - Pharmaceutical Stewardship Act of 2016 S. 3075 - Addiction Prevention and Responsible Opioid Practices Act
Client expense: $920,000 · Firm income: Not reported
2016 · third_quarter · Alcohol and Drug Abuse
Support efforts to address prescription drug abuse and heroin overdose epidemic, including funding. Support S. 524, the Comprehensive Addiction and Recovery Act. Support S. 3075, the Addiction Prevention and Responsible Opioid Practices Act.
Client expense: $34,833 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2016 · second_quarter · Pharmacy
Legislation and policies relating to: H.R. 471/S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act H.R. 639 - Improving Regulatory Transparency for New Medical Therapies Act H.R. 953/S. 524 - Comprehensive Addiction and Recovery Act of 2015 H.R. 2536/S. 1455 - Recovery Enhancement for Addiction Treatment (TREAT) Act H.R. 4435 - Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R. 4843 - Infant Plan of Safe Care Improvement Act H.R. 4978 - NAS Healthy Babies Act H.R. 4981 - Opioid Use Disorder Treatment Expansion and Modernization Act H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 H.R. 5052 - Opioid Program Evaluation Act S. 1392 - Safe Prescribing of Controlled Substances Act S. 2423 - A bill making appropriations to address the heroin and opioid drug abuse epidemic for the fiscal year ending September 30, 2016, and for other purposes S. 3075 - Addiction Prevention and Responsible Opioid Practices Act
Client expense: Not reported · Firm income: $23,450
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office
2016 · second_quarter · Health Issues
Biosimilar Naming, Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Act (GDUFA), PL 112-144 Prescription drug pricing, Medicare Part D program and Generic Drugs HR 6, 21st Century Cures Act; Innovation for Healthier Americans Initiative; Issues regarding market exclusivity Drug Supply Chain Security Act implementation of pharmaceutical distribution REMs program, S. 3056 CREATES Act, H.R. 2841 FAST generics Act S. 1972 Airline Access to Emergency Epinephrine Act of 2015, Anaphylaxis awareness, access to epinephrine auto injector; federal building anaphylaxis policy S. 2615 Increasing Competition in Pharmaceuticals Act, H.R. 4784 Lower Drug Costs through Competition Act, generic medicines pricing issues The Comprehensive Addiction and Recovery Act (CARA) S.524/H.R.953, the Addiction Prevention and Responsible Opioid Practices Act S.3075, Budgeting for CARA
Client expense: $265,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Program Support Center, SENATE, U.S. Trade Representative (USTR), White House Office
2016 · second_quarter · Pharmacy
Policy matters related to generic pharmaceuticals and biosimilars including naming, labeling, access and interchangeability and changes to the Risk Evaluation and Mitigation Strategies (REMS) program, H.R.2841, FAST Generics Act of 2015 and S.3075, The CREATES Act, access to samples for generic testing. Issues related to House Energy and Commerce Committee's draft on H. R. 6, 21st Century Cures Act and the Senate Health, Education, Labor and Pensions Committee Initiative for Healthier Americans. Affordability and pricing of pharmaceuticals. Issues related to drug takeback and opioid addiction, including S.524 and H.R. 953, The Comprehensive Addiction and Recovery Act of 2016. H. R. 4931, The Pharmaceutical Stewardship Act of 2016 and S.2977, The Budgeting for Opioid Addiction Treatment Act.
Client expense: Not reported · Firm income: $60,000
2016 · second_quarter · Taxation/Internal Revenue Code
Taxation Issues Related to Opioid Pharmaceuticals. S.3075: Addiction Prevention and Responsible Opioid Practices Act. S.2977: Budgeting for Opioid Addiction Treatment Act.
Client expense: $802,333 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · second_quarter · Alcohol and Drug Abuse
Support efforts to address prescription drug abuse and heroin overdose epidemic, including funding. Support S. 524, the Comprehensive Addiction and Recovery Act. Support S. 3075, the Addiction Prevention and Responsible Opioid Practices Act.
Client expense: $41,958 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
2016 · second_quarter · Alcohol and Drug Abuse
H.R. 471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524 - Comprehensive Addiction and Recovery Act of 2016 H.R.953 - Comprehensive Addiction and Recovery Act of 2015 HR 3250 - DXM Abuse Prevention Act S. 2294 - DXM Abuse Prevention Act H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 H.R.4931 - Pharmaceutical Stewardship Act of 2016 S. 3075 - Addiction Prevention and Responsible Opioid Practices Act
Client expense: $920,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE