Loading…
Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
61pct
22d open
vs 6,526 other HR bills in the 114th — cohort avg 56d
Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. This bill amends the Public Health Service Act to revise and extend through FY2020 the controlled substance monitoring program. Government entities receiving nonidentifiable information from a controlled substance monitoring database for research purposes may make that information available to other entities for research purposes. A state receiving a grant for a controlled substance monitoring program must: (1) facilitate prescriber and dispenser use of the state's controlled substance monitoring system, and (2) educate prescribers and dispensers on the benefits of the system. This bill amends the Omnibus Crime Control and Safe Streets Act of 1968 to extend the Edward Byrne Memorial Justice Assistance Grant Program through FY2020. HHS must advance education and awareness of the risk of abuse of prescription opioids (drugs with effects similar to opium). The Office of National Drug Control Policy (ONDCP), in coordination with HHS and the DEA, must establish a national drug awareness campaign that emphasizes the similarities between heroin and prescription opioids. The DEA, in coordination with HHS and ONDCP, may make grants to state, local, or tribal governments to create demonstration programs to allow first responders to prevent opioid overdose death by administering an opioid overdose reversal drug (e.g., naloxone).
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 (16)
Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations.
Referred to the Subcommittee on Health.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Congress.gov source codes: H11100, H11100-A
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2025 · fourth_quarter · Telecommunications
Issues related to the availability and appropriate uses of commercial spectrum, the integrity and security of commercial networks, broadband availability, pricing and permitting, universal service, privacy, telecommunications supply chain security, implementation and reauthorization of the Nationwide Broadband Public Safety Network operated by the First Responder Network Authority, next generation-911, legislation designed to streamline broadband infrastructure deployment and permit placement of wireless towers on federal property. S 259 Foreign Adversary Communications Transparency (FACT) Act, issues related to foreign ownership interests S 323 PLAN for Broadband Act, all provisions HR 651 Spectrum Pipeline Act, all provisions S 866 Accelerating Broadband Permits Act, all provisions S 1337 Cybersecurity Information Sharing Extension Act, provisions related to liability protections HR 1343 Federal Broadband Deployment Tracking Act, all provisions S 1396, Content Origin Protection and Integrity from Edited and Deepfaked Media Act (COPIED ACT), provisions impacting internet and communications service providers HR 1519 Public Safety Communications Act, all provisions HR 1541Wireless Broadband Competition and Efficient Deployment Act, all provisions HR 1681, Expediting Federal Broadband Deployment Act, all provisions HR 1870SPEED for BEAD Act, all provisions S 1829/ HR 3921, Strengthening Transparency and Obligations to Protect Children Suffering from Abuse and Mistreatment Act (STOP CSAM Act), provisions impacting internet and communications service providers HR 1975 BEAD FEE Act, all provisions S 2253, Unsubscribe Act, provisions impacting internet and communications service providers S 2316/HR 4518, Cooper Davis and Devin Norring Act, provisions impacting internet and communications service providers S 2480, Telecom Cybersecurity Transparency Act, provisions impacting internet and communications service providers HR 2482NTIA Reauthorization Act, all provisions HR 2449 FUTURE Networks Act, all provisions S 1137/HR 2350Cellphone Jamming Reform Act, all provisions S 1071/S 2296 National Defense Authorization Act for Fiscal Year 2026, including issues relating to the authorization to change spectrum bands available for auction HR 2298Reducing Barriers for Broadband on Federal Lands Act, all provisions HR 2289Proportional Reviews for Broadband Deployment Act, all provisions HR 2171Spectrum Coordination Act, all provisions S 2455, TRAIN Act, provisions impacting internet and communications service providers S 2666, Foreign Robocall Elimination Act, provisions impacting internet and communications service providers S 2714, CHAT Act, provisions impacting internet and communications service providers HR 2750, Bridging the Broadband Gap Act, all provisions S 2750, Strengthening Artificial intelligence Normalization and Diffusion By Oversight and eXperimentation Act (SANDBOX Act), provisions impacting internet and communications service providers HR 2805 PLAN for Broadband Act, all provisions HR 2817 Coastal Broadband Deployment Act, all provisions HR 2975 Broadband Incentives for Communities Act, all provisions S 2983 Extending Expired Cybersecurity Authorities Act, provisions related to liability protections HR 3125 Rural Broadband Assistance Act, all provisions S 3268/HR 6046 Broadband and Telecommunications RAIL Act, all provisions HR 3479 SECURE Americans Telecommunications Act, all provisions HR 4032 Lowering Broadband Costs for Consumers Act, all provisions HR 4950, Data Broadband Reporting and Integration for Deployment in Geographically Essential Areas Act, provisions impacting internet and communications service providers HR 5079, Widespread Information Management for the Welfare of Infrastructure and Government Act, provisions related to liability protections HR 5266 5G UPGRADE ACT, all provisions HR 5371 Continuing Appropriations and Extensions Act, 2026 Sec 145, provisions related to liability protections HR 6484 Kids Online Safety Act, provisions impacting internet service providers HR 6505 Next Generation 9-1-1 Act, all provisions Draft, Provide Rigorous Oversight To Optimize Connectivity and Offset Latency Act, all provisions Draft, Reauthorization of Cybersecurity Information Act of 2015, provisions related to liability protections Draft, FCC Merger Efficiency Reform for Growth and Expedited Review Act
Client expense: $2,860,000 · Firm income: Not reported
Government targets: Federal Aviation Administration (FAA), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), SENATE, Transportation, Dept of (DOT), White House Office
2025 · second_quarter · Telecommunications
Issues related to the availability and appropriate uses of commercial spectrum, the integrity and security of commercial networks, broadband availability, pricing and permitting, universal service, privacy, telecommunications supply chain security, implementation of the Nationwide Broadband Public Safety Network operated by the First Responder Network Authority, legislation designed to streamline broadband infrastructure deployment and permit placement of wireless towers on federal property. HR 1 One Big Beautiful Bill Act, Title IV, Sec. 40002. Spectrum auctions. S 259 Foreign Adversary Communications Transparency (FACT) Act, issues related to foreign ownership interests S 323 PLAN for Broadband Act, all provisions HR 651 Spectrum Pipeline Act, all provisions S 866 Accelerating Broadband Permits Act, all provisions S 1337 Cybersecurity Information Sharing Extension Act, provisions related to liability protections HR 1343 Federal Broadband Deployment Tracking Act, all provisions HR 1519 Public Safety Communications Act, all provisions HR 1541Wireless Broadband Competition and Efficient Deployment Act, all provisions HR 1870SPEED for BEAD Act, all provisions HR 1975 BEAD FEE Act, all provisions HR 2482NTIA Reauthorization Act, all provisions HR 2449 FUTURE Networks Act, all provisions S 1137/HR 2350Cellphone Jamming Reform Act, all provisions HR 2298Reducing Barriers for Broadband on Federal Lands Act, all provisions HR 2289Proportional Reviews for Broadband Deployment Act, all provisions HR 2171Spectrum Coordination Act, all provisions HR 2750 Bridging the Broadband Gap Act, all provisions HR 2805 PLAN for Broadband Act, all provisions HR 2817 Coastal Broadband Deployment Act, all provisions HR 2975 Broadband Incentives for Communities Act, all provisions HR 3125 Rural Broadband Assistance Act, all provisions HR 3479 SECURE Americans Telecommunications Act, all provisions HR 4032 Lowering Broadband Costs for Consumers Act, all provisions Draft, Provide Rigorous Oversight To Optimize Connectivity and Offset Latency Act, all provisions Draft, Reauthorization of Cybersecurity Information Act of 2015, provisions related to liability protections Draft, FCC Merger Efficiency Reform for Growth and Expedited Review Act
2016 · fourth_quarter · Alcohol and Drug Abuse
H.R.471-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3865-Cradle Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 S.36-Protecting Our Youth from Dangerous Synthetic Drugs Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.483-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.954-FDA Accountability for Public Safety Act S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1327-Synthetic Abuse and Labeling of Toxic Substances (SALTS) Act S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1654-Overdose Prevention Act S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2687-Plan of Safe Care Improvement Act
2016 · fourth_quarter · Health Issues
H.R.6-21st Century Cures Act H.R.33-Protecting Volunteer Firefighters and Emergency Responders Act H.R.34-21st Century Cures Act H.R.290-Creating Access to Rehabilitation for Every Senior (CARES) Act of 2015 H.R.293-To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes. H.R.398-Trafficking Awareness Training for Health Care Act H.R.639-Improving Regulatory Transparency for New Medical Therapies Act H.R.647-Access to Life-Saving Trauma Care for All Americans Act H.R.648-Trauma Systems and Regionalization of Emergency Care Reauthorization Act H.R.836-Health Care Safety Net Enhancement Act H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1190-Protecting Seniors Access to Medicare Act of 2015 H.R.1571-Improving Access to Medicare Coverage Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1818-Veteran Emergency Medical Technician Support Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.1854-Comprehensive Justice and Mental Health Act of 2015 H.R.1877-Mental Health First Aid Act of 2015 H.R.2050-Middle Class Health Benefits Tax Repeal Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2366-Field EMS Modernization and Innovation Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2603-Saving Lives, Saving Costs Act H.R.2646-Helping Families in Mental Health Crisis Act of 2015 H.R.2799-Furthering Access to Stroke Telemedicine (FAST) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.2948-Medicare Telehealth Parity Act of 2015 H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3081-TELEmedicine for MEDicare (TELE-MED) Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3299-Strengthening Public Health Emergency Response Act H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3681-Improving Access to Emergency Psychiatric Care Act H.R.3682-Reducing Employer Burdens, Unleashing Innovation, and Labor Development Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3762-Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R.3770-End Surprise Billing Act of 2015 H.R.3865-Cradle Act H.R.4059-Medicare Choices Empowerment and Protection Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4150-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act H.R.4365-Protecting Patient Access to Emergency Medications Act of 2016 H.R.4435-Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 H.R.4771-Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R.4732-Advancing Medical Resident Training in Community Hospitals Act of 2016 H.R.5243-Zika Response Appropriations Act H.R.5273-Helping Hospitals Improve Patient Care H.R.5284-World's Greatest Healthcare Plan Act of 2016 H.R.5547-Health Care Price Transparency Promotion Act of 2016 H.Res.877-Encouraging each State to enact legislation that increases the likelihood of survival after sudden cardiac arrest in our Nation's schools. S.141-Protecting Seniors Access to Medicare Act of 2015 S.425-Homeless Veterans' Reintegration Programs Reauthorization Act of 2015 S.453-Veteran Emergency Medical Technician Support Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.599-Improving Access to Emergency Psychiatric Care Act S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.711-Mental Health First Act of 2015 S.763-Trauma Systems and Regionalization of Emergency Care Reauthorization Act S.884-Health Care Safety Net Enhancement Act S.843-Improving Access to Medicare Coverage Act of 2015 S.954-FDA Accountability for Public Safety Act S.993-Comprehensive Justice and Mental Health Act of 2015 S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1446-SOAR to Health and Wellness Act of 2015 S.1450-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act S.1452-Veterans Emergency Health Safety Net Expansion Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1465-Furthering Access to Stroke Telemedicine (FAST) Act S.1475-Saving Lives, Saving Costs Act S.1549-Care Planning Act of 2015 S.1648-Rural Emergency Acute Care Hospital (REACH) Act S.1654-Overdose Prevention Act S.1693-To amend title 38, United States Code, to expand eligibility for reimbursement for emergency medical treatment to certain veterans that were unable to receive care from the Department of Veterans Affairs in the 24-month period preceding the furnishing of such emergency treatment, and for other purposes. S.1778-TELEmedicine for MEDicare (TELE-MED) Act of 2015 S.1893-Mental Health Awareness and Improvement Act of 2015 S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.1945-Mental Health Reform Act of 2015 S.2002-Mental Health and Safe Communities Act of 2015 S.2045-Middle Class Health Benefits Tax Repeal Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2297-Medicare Choices Empowerment and Protection Act S.2525-Expand Excellence in Mental Health Act S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2597-Medicare Mental Health Access Act S.2671-Advancing Medical Resident Training in Community Hospitals Act of 2016 S.2680-Mental Health Reform Act of 2016 S.2687-Plan of Safe Care Improvement Act S.2932-Protecting Patient Access to Emergency Medications Act of 2016 S.2985-World's Greatest Healthcare Plan Act of 2016 S. 3407, Military Injury Surgical Systems Integrated Operationally Nationwide to Achieve ZERO Preventable Deaths (MISSION ZERO) Act P.L.114-10-Medicare Access and CHIP Reauthorization Act of 2015 P.L.114-324-Justice for All Reauthorization Act
2016 · fourth_quarter · Law Enforcement/Crime/Criminal Justice
Monitor legislative and administrative activity related to funding for law enforcement legislation, initiatives, and the COPS program. H.R. 1854, Comprehensive Justice and Mental Health Act of 2015. S.993, Comprehensive Justice and Mental Health Act of 2015. H.R. 2805, Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015. S. 524, Comprehensive Addiction and Recovery Act of 2016.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
| Republican |
| VA |
| Ben Ray Luján | Democratic | NM |
| Brad R. Wenstrup | Republican | OH |
| Charles W. Dent | Republican | PA |
| Darin LaHood | Republican | IL |
| Derek Kilmer | Democratic | WA |
| Doris O. Matsui | Democratic | CA |
| Ed Whitfield | Republican | KY |
| Elise M. Stefanik | Republican | NY |
| Elizabeth H. Esty | Democratic | CT |
| Eric Swalwell | Democratic | CA |
| Frank C. Guinta | Republican | NH |
| Greg Walden | Republican | OR |
| Jackie Walorski | Republican | IN |
| Jaime Herrera Beutler | Republican | WA |
| James B. Renacci | Republican | OH |
| James P. McGovern | Democratic | MA |
| John C. Carney Jr. | Democratic | DE |
| John Katko | Republican | NY |
| Joseph P. Kennedy III | Democratic | MA |
| Katherine M. Clark | Democratic | MA |
| Kathleen M. Rice | Democratic | NY |
| Keith J. Rothfus | Republican | PA |
| Lou Barletta | Republican | PA |
| Luke Messer | Republican | IN |
| Marcy Kaptur | Democratic | OH |
| Mimi Walters | Republican | CA |
| Robert J. Dold | Republican | IL |
| Rodney Davis | Republican | IL |
| Ron Kind | Democratic | WI |
| Ryan A. Costello | Republican | PA |
| Sander M. Levin | Democratic | MI |
| Scott H. Peters | Democratic | CA |
| Scott R. Tipton | Republican | CO |
| Sean Patrick Maloney | Democratic | NY |
| Seth Moulton | Democratic | MA |
| Steve Chabot | Republican | OH |
| Steve Stivers | Republican | OH |
| Tim Ryan | Democratic | OH |
| Tim Walberg | Republican | MI |
| Todd Young | Republican | IN |
| Vicky Hartzler | Republican | MO |
| William R. Keating | Democratic | MA |
Client expense: $2,140,000 · Firm income: Not reported
Government targets: Federal Aviation Administration (FAA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Natl Economic Council (NEC), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), SENATE, Transportation, Dept of (DOT), Veterans Affairs, Dept of (VA), White House Office
Client expense: $462,139 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $462,139 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Law Enforcement/Crime/Criminal Justice
Monitor legislative and administrative action related to criminal justice reform. H.R. 1854, Comprehensive Justice and Mental Health Act of 2015. S. 993, Comprehensive Justice and Mental Health Act of 2015. H.R. 2805, Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015. S. 524, Comprehensive Addiction and Recovery Act of 2016.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, White House Office
2016 · fourth_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6 / H.R. 34: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation and other issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
Client expense: $4,990,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · fourth_quarter · Pharmacy
Opioid Abuse; Opioid Education; Prescription Drugs, HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st Century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education and Enforcement Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN) this bill requires the Department of Health and Human Services (HHS)in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program and for other purposes.
Client expense: $60,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Pharmacy
Opioid Abuse; Opioid Education; Prescription Drugs. HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015. The bill amends the Public Health Service Act to authorize the Center for Substance Abuse Treatment to award grants to enable state substance abuse agencies, local governments, nonprofit organizations, and Indian tribes or tribal organizations that have a high rate of, or have had a rapid increase in, the use of heroin or other opioids to expand activities, including medication assisted treatment, for the treatment of addiction in the geographical areas affected. The Comprehensive Recovery Act, S. 524 was introduced by Sen. Sheldon Whitehouse (D-RI) and HR 953 to tackle the growing epidemic. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education and Enforcement Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN). This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veteran Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA) to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practice for pain management and prescription of pain medication. HR 4499 Introduced February 9, 206 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.
Client expense: $20,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Pharmacy
Opioid Abuse; Opiod Education; Prescription Drugs HR 953 Introduced February 12, 2015 by James Sensenbrenner, JR. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin,prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related deaths in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and H.R. 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI5) and will receive a hearing on Thursday from the Senate Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement-Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN). This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend Title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Pharmacy
Precision Medicine Act (S2713); General Pharmacy Issues (HR6/2713); opioid abuse (S524, HR953, HR2805, HR4499); specialty drug pricing
Client expense: $30,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · fourth_quarter · Pharmacy
Opioid Abuse; Opioid Education; Prescription Drugs HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and H.R. 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI5) and will receive a hearing on Thursday from the Senate Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement -Act of 2015 Introduced June 17, 2915 by Susan Brooks (R-IN) This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.
Client expense: $2,160,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2016 · third_quarter · Pharmacy
Opioid Abuse; Opiod Education; Prescription Drugs; Pharmaceutical Innovation. HR 953 Introduced February 12, 2015 by James Sensenbrenner, JR. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin,prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related deaths in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and H.R. 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI5) and will receive a hearing on Thursday from the Senate Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement-Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN). This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend Title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Law Enforcement/Crime/Criminal Justice
Monitor legislative and administrative action related to criminal justice reform. H.R. 1854, Comprehensive Justice and Mental Health Act of 2015. S. 993, Comprehensive Justice and Mental Health Act of 2015. H.R. 2805, Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015. S. 524, Comprehensive Addiction and Recovery Act of 2016.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2016 · third_quarter · Law Enforcement/Crime/Criminal Justice
Monitor legislative and administrative activity related to funding for law enforcement legislation, initiatives, and the COPS program. H.R. 1854, Comprehensive Justice and Mental Health Act of 2015. S.993, Comprehensive Justice and Mental Health Act of 2015. H.R. 2805, Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015. S. 524, Comprehensive Addiction and Recovery Act of 2016.
Client expense: Not reported · Firm income: $30,000
Government targets: Federal Aviation Administration (FAA), HOUSE OF REPRESENTATIVES, SENATE, White House Office
2016 · third_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S.2055: Medical Countermeasure Innovation Act of 2015 S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 H.R. 3299: The Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Other: - Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures - Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy - Proposed HRSA 340B program mega-guidance - Provisions related to 340B program - Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) reauthorization - Biosimilar User Fee Act (BsUFA) reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Biomarker policy issues - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial size policy issues - House Republican Health Proposal (A Better Way) - OTC Monograph Reform - Expanded access policy issues - Patient assistance program policy issues
Client expense: $640,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · third_quarter · Health Issues
Issues related to the treatment of opioid addiction, including: PL 114-198, the Comprehensive Addiction Recovery Act (CARA) and its implementation; S. 1893, Mental Health Awareness and Improvement Act of 2015; H.R. 3691, Improving Treatment for Pregnant and Postpartum Women Act; H.R. 3680, Co-Prescribing to Reduce Overdoses Act of 2015; H.R. 2536/S.1455, the Recovery Enhancement for Addiction Treatment Act; H.R. 2805; the Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015; and H.R. 2872, the Opioid Addiction Treatment Modernization Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE
2016 · third_quarter · Pharmacy
Opioid Abuse; Opioid Education; Prescription Drugs, Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Death have reached their highest levels of the 21st Century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and HR 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI) and will receive a hearing on Thursday before the Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education and Enforcement Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN) this bill requires the Department of Health and Human Services (HHS)in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program and for other purposes.
Client expense: $50,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)
Client expense: $4,550,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · third_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2912: Trickett Wendler Right to Try Act of 2016 - A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs S. 3239: RACE for Children Act - Provisions related to pediatric studies S. 3335: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act - Provisions relating to transparency H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 or FAST Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5122: A bill to prohibit further action on the proposed rule regarding testing of Medicare Part B prescription drug models H.R. 5858: The RACE for Children Act - Provisions related to pediatric studies H.R. 6043: Fair Accountability and Innovative Research (FAIR) Drug Pricing Act of 2016 - Provisions related to transparency H.R. 6174: Closing Loopholes for Orphan Drugs Act - Provisions relating to 340B discounts on orphan drugs Kids Innovative Drugs Act (draft) - Incentives for the development of pediatric oncology drugs The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Incentives for the development of pediatric drugs Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) reauthorization Biosimilar User Fee Act (BsUFA) reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way) Expanded access policy issues
Client expense: $4,130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · third_quarter · Pharmacy
Opioid Abuse; Opioid Education; Prescription Drugs; Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015. The bill amends the Public Health Service Act to authorize the Center for Substance Abuse Treatment to award grants to enable state substance abuse agencies, local governments, nonprofit organizations, and Indian tribes or tribal organizations that have a high rate of, or have had a rapid increase in, the use of heroin or other opioids to expand activities, including medication assisted treatment, for the treatment of addiction in the geographical areas affected. The Comprehensive Recovery Act, S. 524 was introduced by Sen. Sheldon Whitehouse (D-RI) and HR 953 to tackle the growing epidemic. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education and Enforcement Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN). This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veteran Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA) to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practice for pain management and prescription of pain medication. HR 4499 Introduced February 9, 206 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Pharmacy
Opioid Abuse; Opioid Education; Prescription Drugs; Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and H.R. 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI5) and will receive a hearing on Thursday from the Senate Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement -Act of 2015 Introduced June 17, 2915 by Susan Brooks (R-IN) This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.
Client expense: $2,150,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2016 · third_quarter · Health Issues
Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Substance Use Disorder (general); HIV Screening (general); Gynecologic Cancer (general); Gynecologic devices (general); Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality and Morbidity (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); Healthy Start (general); H.R.4695/S. 466, Quality Care for Moms and Babies Act; H.R. 3865/S.2542, Cradle Act;; H.R. 865/S. 3101, Good Samaritan Health Professionals Act; H.R. 4774, Training Tomorrows Doctors Today Act; H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016; H.R. 1209/S.628 Improving Access to Maternity Care Act; Implementation of H.R. 1462/S. 799, Protecting our Infants Act; H.R. 3691/S. 2226, Improving Treatment for Pregnant and Postpartum Women Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 2972, Equal Access to Abortion Coverage in Health Insurance (EACH Woman) Act; H.Res. 461, Establishing a Select Investigative Panel of the Committee on Energy and Commerce; Fetal Tissue Research (General); H.R. 3706/S.1911, Reach Every Mother and Child Act of 2016; H.Res. 558/S.Res. 327, Condemning Violence That Targets Healthcare for Women; S. 304, Conscience Protection Act; H.R. 3504, Born-Alive Abortion Survivors Protection Act; Hyde Amendment (General); Senate Biomedical Innovations Packages (general); S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act; S.2742, Promoting Biomedical Research and Public Health for Patients Act; H.R. 6, 21st Century Cures Act; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3652/S. 674, 21st Century Womens Health Act; S. 1532, Affordability is Access Act; H.R. 5746, Birth Control Privacy Act; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3235/S. 2311, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); and H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act; H.R. 5369, Healthy Start Reauthorization Act; S. 3070, Hygiene Assistance for Families of Infants and Toddlers Act of 2016; H.R. 5219 Safe Medications for Moms and Babies Act of 2016; H.R. 953/S. 524, Comprehensive Addiction and Recovery Act; H.R. 2646, Helping Families in Mental Health Crisis Act; S. 2680, Mental Health Reform Act; H.R. 3537, Synthetic Drug Control Act; H.R. 4499/S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act; H.R. 4874, Prevent Abuse by Using Interstate Exchange Act; H.R. 2805/S. 1134, Heroin and Prescription Opioid Abuse, Prevention, Education, and Enforcement Act; H.R. 2654/S. 1512, Pregnant Workers Fairness Act; H.R. 1706/S.2765, Real Education for Healthy Youth Act; H.R. 5065/ S. 3299 Bottles and Breastfeeding Equipment Screening Act; H.R. 6010, Zika Pregnancy and Infant Registry Act.
Client expense: $436,321 · Firm income: Not reported
Government targets: Administration for Children & Families (ACF), Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, U.S. Agency for International Development (USAID), White House Office
2016 · third_quarter · Pharmacy
General Pharmacy Issues (HR6/2713); opioid abuse (S524, HR953, HR2805, HR4499); specialty drug pricing
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2016 · third_quarter · Alcohol and Drug Abuse
H.R.471-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3865-Cradle Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 S.36-Protecting Our Youth from Dangerous Synthetic Drugs Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.483-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.954-FDA Accountability for Public Safety Act S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1327-Synthetic Abuse and Labeling of Toxic Substances (SALTS) Act S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1654-Overdose Prevention Act S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2687-Plan of Safe Care Improvement Act
Client expense: $512,329 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
H.R.6-21st Century Cures Act H.R.33-Protecting Volunteer Firefighters and Emergency Responders Act H.R.290-Creating Access to Rehabilitation for Every Senior (CARES) Act of 2015 H.R.293-To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes. H.R.398-Trafficking Awareness Training for Health Care Act H.R.639-Improving Regulatory Transparency for New Medical Therapies Act H.R.647-Access to Life-Saving Trauma Care for All Americans Act H.R.648-Trauma Systems and Regionalization of Emergency Care Reauthorization Act H.R.836-Health Care Safety Net Enhancement Act H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1190-Protecting Seniors Access to Medicare Act of 2015 H.R.1571-Improving Access to Medicare Coverage Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1818-Veteran Emergency Medical Technician Support Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.1854-Comprehensive Justice and Mental Health Act of 2015 H.R.1877-Mental Health First Aid Act of 2015 H.R.2050-Middle Class Health Benefits Tax Repeal Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2366-Field EMS Modernization and Innovation Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2603-Saving Lives, Saving Costs Act H.R.2646-Helping Families in Mental Health Crisis Act of 2015 H.R.2799-Furthering Access to Stroke Telemedicine (FAST) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.2948-Medicare Telehealth Parity Act of 2015 H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3081-TELEmedicine for MEDicare (TELE-MED) Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3299-Strengthening Public Health Emergency Response Act H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3681-Improving Access to Emergency Psychiatric Care Act H.R.3682-Reducing Employer Burdens, Unleashing Innovation, and Labor Development Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3762-Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R.3770-End Surprise Billing Act of 2015 H.R.3865-Cradle Act H.R.4059-Medicare Choices Empowerment and Protection Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4150-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act H.R.4365-Protecting Patient Access to Emergency Medications Act of 2016 H.R.4435-Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 H.R.4771-Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R.4732-Advancing Medical Resident Training in Community Hospitals Act of 2016 H.R.5243-Zika Response Appropriations Act H.R.5273-Helping Hospitals Improve Patient Care H.R.5284-World's Greatest Healthcare Plan Act of 2016 H.R.5547-Health Care Price Transparency Promotion Act of 2016 S.141-Protecting Seniors Access to Medicare Act of 2015 S.425-Homeless Veterans' Reintegration Programs Reauthorization Act of 2015 S.453-Veteran Emergency Medical Technician Support Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.599-Improving Access to Emergency Psychiatric Care Act S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.711-Mental Health First Act of 2015 S.763-Trauma Systems and Regionalization of Emergency Care Reauthorization Act S.884-Health Care Safety Net Enhancement Act S.843-Improving Access to Medicare Coverage Act of 2015 S.954-FDA Accountability for Public Safety Act S.993-Comprehensive Justice and Mental Health Act of 2015 S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1446-SOAR to Health and Wellness Act of 2015 S.1450-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act S.1452-Veterans Emergency Health Safety Net Expansion Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1465-Furthering Access to Stroke Telemedicine (FAST) Act S.1475-Saving Lives, Saving Costs Act S.1549-Care Planning Act of 2015 S.1648-Rural Emergency Acute Care Hospital (REACH) Act S.1654-Overdose Prevention Act S.1693-To amend title 38, United States Code, to expand eligibility for reimbursement for emergency medical treatment to certain veterans that were unable to receive care from the Department of Veterans Affairs in the 24-month period preceding the furnishing of such emergency treatment, and for other purposes. S.1778-TELEmedicine for MEDicare (TELE-MED) Act of 2015 S.1893-Mental Health Awareness and Improvement Act of 2015 S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.1945-Mental Health Reform Act of 2015 S.2002-Mental Health and Safe Communities Act of 2015 S.2045-Middle Class Health Benefits Tax Repeal Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2297-Medicare Choices Empowerment and Protection Act S.2525-Expand Excellence in Mental Health Act S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2597-Medicare Mental Health Access Act S.2671-Advancing Medical Resident Training in Community Hospitals Act of 2016 S.2680-Mental Health Reform Act of 2016 S.2687-Plan of Safe Care Improvement Act S.2932-Protecting Patient Access to Emergency Medications Act of 2016 S.2985-World's Greatest Healthcare Plan Act of 2016 P.L.114-10-Medicare Access and CHIP Reauthorization Act of 2015
Client expense: $512,329 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Law Enforcement/Crime/Criminal Justice
Monitor legislative and administrative activity related to funding for law enforcement legislation, initiatives, and the COPS program. H.R. 1854, Comprehensive Justice and Mental Health Act of 2015. S.993, Comprehensive Justice and Mental Health Act of 2015. H.R. 2805, Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015. S. 524, Comprehensive Addiction and Recovery Act of 2016.
Client expense: Not reported · Firm income: $30,000
Government targets: Federal Aviation Administration (FAA), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE, White House Office
2016 · second_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 2055 - the Medical Countermeasure Innovation Act of 2015 S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Other: - Kids Innovative Drugs Act (draft) - The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments - Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development - ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances - Drug Supply Chain Security Act policy issues - Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) - Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues - Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures - Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy - Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges - 340B Drug Discount Program policy issues - General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals - Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization - Biologics Price Competition and Innovation Act (BPCIA) implementation issues - Biopharmaceutical and medical innovation policy issues - Drug development ecosystem policy issues - Drug cost and pricing policy issues - Expedited drug approval policy issues - Compassionate use policy issues - Biosimilar approval and reimbursement policy issues - Transparency policy issues - NIH Funding policy issues - Precision Medicine Initiative - Policy issues related to prescription drug abuse and secure disposal - Drug compounding policy issues - Prescription drug importation policy issues - Cancer Moonshot - Prescription drug take back policy issues - Clinical trial policy issues - Pediatric cancer policy issues - Cancer drug vial sizes policy issues - House Republican Health Proposal (A Better Way)
Client expense: $1,070,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
2016 · second_quarter · Law Enforcement/Crime/Criminal Justice
Monitor legislative and administrative action related to criminal justice reform. H.R. 1854, Comprehensive Justice and Mental Health Act of 2015. S. 993, Comprehensive Justice and Mental Health Act of 2015. H.R. 2805, Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015. S. 524, Comprehensive Addiction and Recovery Act of 2016.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2016 · second_quarter · Alcohol and Drug Abuse
H.R.471-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3865-Cradle Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 S.36-Protecting Our Youth from Dangerous Synthetic Drugs Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.483-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.954-FDA Accountability for Public Safety Act S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1327-Synthetic Abuse and Labeling of Toxic Substances (SALTS) Act S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1654-Overdose Prevention Act S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2687-Plan of Safe Care Improvement Act
Client expense: $217,135 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
H.R.6-21st Century Cures Act H.R.33-Protecting Volunteer Firefighters and Emergency Responders Act H.R.290-Creating Access to Rehabilitation for Every Senior (CARES) Act of 2015 H.R.293-To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes. H.R.398-Trafficking Awareness Training for Health Care Act H.R.639-Improving Regulatory Transparency for New Medical Therapies Act H.R.647-Access to Life-Saving Trauma Care for All Americans Act H.R.648-Trauma Systems and Regionalization of Emergency Care Reauthorization Act H.R.836-Health Care Safety Net Enhancement Act H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1190-Protecting Seniors Access to Medicare Act of 2015 H.R.1571-Improving Access to Medicare Coverage Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1818-Veteran Emergency Medical Technician Support Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.1854-Comprehensive Justice and Mental Health Act of 2015 H.R.1877-Mental Health First Aid Act of 2015 H.R.2050-Middle Class Health Benefits Tax Repeal Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2366-Field EMS Modernization and Innovation Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2603-Saving Lives, Saving Costs Act H.R.2646-Helping Families in Mental Health Crisis Act of 2015 H.R.2799-Furthering Access to Stroke Telemedicine (FAST) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.2948-Medicare Telehealth Parity Act of 2015 H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3081-TELEmedicine for MEDicare (TELE-MED) Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3299-Strengthening Public Health Emergency Response Act H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3681-Improving Access to Emergency Psychiatric Care Act H.R.3682-Reducing Employer Burdens, Unleashing Innovation, and Labor Development Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3762-Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R.3770-End Surprise Billing Act of 2015 H.R.3865-Cradle Act H.R.4059-Medicare Choices Empowerment and Protection Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4150-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act H.R.4365-Protecting Patient Access to Emergency Medications Act of 2016 H.R.4435-Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 H.R.4771-Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 H.R.4732-Advancing Medical Resident Training in Community Hospitals Act of 2016 H.R.5243-Zika Response Appropriations Act H.R.5273-Helping Hospitals Improve Patient Care H.R.5284-World's Greatest Healthcare Plan Act of 2016 H.R.5547-Health Care Price Transparency Promotion Act of 2016 S.141-Protecting Seniors Access to Medicare Act of 2015 S.425-Homeless Veterans' Reintegration Programs Reauthorization Act of 2015 S.453-Veteran Emergency Medical Technician Support Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.599-Improving Access to Emergency Psychiatric Care Act S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.711-Mental Health First Act of 2015 S.763-Trauma Systems and Regionalization of Emergency Care Reauthorization Act S.884-Health Care Safety Net Enhancement Act S.843-Improving Access to Medicare Coverage Act of 2015 S.954-FDA Accountability for Public Safety Act S.993-Comprehensive Justice and Mental Health Act of 2015 S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1446-SOAR to Health and Wellness Act of 2015 S.1450-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act S.1452-Veterans Emergency Health Safety Net Expansion Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1465-Furthering Access to Stroke Telemedicine (FAST) Act S.1475-Saving Lives, Saving Costs Act S.1549-Care Planning Act of 2015 S.1648-Rural Emergency Acute Care Hospital (REACH) Act S.1654-Overdose Prevention Act S.1693-To amend title 38, United States Code, to expand eligibility for reimbursement for emergency medical treatment to certain veterans that were unable to receive care from the Department of Veterans Affairs in the 24-month period preceding the furnishing of such emergency treatment, and for other purposes. S.1778-TELEmedicine for MEDicare (TELE-MED) Act of 2015 S.1893-Mental Health Awareness and Improvement Act of 2015 S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.1945-Mental Health Reform Act of 2015 S.2002-Mental Health and Safe Communities Act of 2015 S.2045-Middle Class Health Benefits Tax Repeal Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2297-Medicare Choices Empowerment and Protection Act S.2525-Expand Excellence in Mental Health Act S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2597-Medicare Mental Health Access Act S.2671-Advancing Medical Resident Training in Community Hospitals Act of 2016 S.2680-Mental Health Reform Act of 2016 S.2687-Plan of Safe Care Improvement Act S.2932-Protecting Patient Access to Emergency Medications Act of 2016 S.2985-World's Greatest Healthcare Plan Act of 2016
Client expense: $217,135 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Issues related to the treatment of opioid addiction, including: S. 524, the Comprehensive Addiction Recovery Act (CARA) and amendments thereto; S. 1893, Mental Health Awareness and Improvement Act of 2015; H.R. 3691, Improving Treatment for Pregnant and Postpartum Women Act; H.R. 3680, Co-Prescribing to Reduce Overdoses Act of 2015; H.R. 2536/S.1455, the Recovery Enhancement for Addiction Treatment Act; H.R. 2805; the Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015; and H.R. 2872, the Opioid Addiction Treatment Modernization Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE
2016 · second_quarter · Pharmacy
Opioid Abuse; Opiod Education; Prescription Drugs; Pharmaceutical Innovation. HR 953 Introduced February 12, 2015 by James Sensenbrenner, JR. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin,prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related deaths in America, accordiing to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and H.R. 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI5) and will receive a hearing on Thursday from the Senate Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement-Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN). This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend Title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.
Client expense: $8,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to National Institutes of Health (NIH) funding S. 320: Medical Innovation Act of 2015 - Provisions related to NIH funding and covered manufacturer supplemental fees S. 480: National All Schedules Prescription Electronic Reporting Reauthorization Act of 2016 - Provisions related to the reauthorization of the national controlled substance monitoring program S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 800: Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act - Issues related to the biopharmaceutical industry S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1077: Advancing Breakthrough Devices for Patients Act of 2016 - Issues related to the biopharmaceutical industry S. 1101: Medical Electronic Data Technology Enhancement for Consumers' Health Act - Provisions related to regulation of software S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1622: FDA Device Accountability Act of 2016 - Issues related to the biopharmaceutical industry S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055: Medical Countermeasure Innovation Act of 2016 - Provisions related to priority review vouchers S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2511: Improving Health Information Technology Act - Provisions related to health information technology (HIT) S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH S. 2713: Advancing Precision Medicine Act of 2016 - Provisions related to data sharing and security S. 2742: Promoting Biomedical Research and Public Health for Patients Act - Issues related to the biopharmaceutical industry S. 2912: A bill to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes - Provisions related to use of unapproved medical products by patients with a terminal illness S. 3056: CREATES Act of 2016 - Provisions related to access to samples of prescription drugs H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on medical research H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3012: Right to Try Act of 2015 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 3250: DXM Abuse Prevention Act of 2015 - Issues related to prescription drug abuse H.R. 3381: Childhood Cancer STAR Act - Provisions related to expanded access and other issues H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications H.R. 5046: Comprehensive Opioid Abuse Reduction Act of 2016 - Provisions related to opioids H.R. 5127: Curb Opioid Abuse By Advancing Technology Act of 2016 - Provisions related to opioids Kids Innovative Drugs Act (draft) The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Drug compounding policy issues Prescription drug importation policy issues Cancer Moonshot Prescription drug take back policy issues Clinical trial policy issues Pediatric cancer policy issues Cancer drug vial size policy issues House Republican Health Proposal (A Better Way)
Client expense: $5,820,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)
2016 · second_quarter · Pharmacy
Opioid Abuse; Opioid Education; Prescription Drugs; Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Deaths have reached their highest levels of the 21st century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and H.R. 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI5) and will receive a hearing on Thursday from the Senate Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement -Act of 2015 Introduced June 17, 2915 by Susan Brooks (R-IN) This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.
Client expense: $2,180,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2016 · second_quarter · Pharmacy
Opioid Abuse; Opioid Education; Perscription Drugs; Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015. The bill amends the Public Health Service Act to authorize the Center for Substance Abuse Treatment to award grants to enable state substance abuse agencies, local governments, nonprofit organizations, and Indian tribes or tribal organizations that have a high rate of, or have had a rapid increase in, the use of heroin or other opioids to expand activities, including medication assisted treatment, for the treatment of addiction in the geographical areas affected. The Comprehensive Recovery Act, S. 524 was introduced by Sen. Sheldon Whitehouse (D-RI) and HR 953 to tackle the growing epidemic. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education and Enforcement Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN). This bill requires the Department of Health and Human Services (HHS), in cooperation with the Department of Veteran Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA) to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best pratice for pain management and perscription of pain medication.
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Pharmacy
Opioid Abuse; Opioid Education; Prescription Drugs, Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) Comprehensive Addiction and Recovery Act of 2015 Overdoses from heroin, prescription drugs, and opioid pain relievers last year surpassed car accidents as the leading cause of injury-related death in America, according to the Centers for Disease Control. Death have reached their highest levels of the 21st Century in 2014, the most recent year for which data is available, according to the National Institute on Drug Abuse. Heroin overdoses have more than tripled in the last five years, an issue receiving outsize attention nationally but especially during the presidential campaign season as New Hampshire has been one of the hardest-hit states. New legislation aims to tackle this epidemic. The Comprehensive Addiction and Recovery Act, S. 524 and HR 953, was introduced by Sen. Sheldon Whitehouse (D-RI) and Rep. Jim Sensenbrenner (R-WI) and will receive a hearing on Thursday before the Judiciary Committee. HR 2805 Heroin and Prescription Opioid Abuse Prevention, Education and Enforcement Act of 2015 Introduced June 17, 2015 by Susan Brooks (R-IN) this bill requires the Department of Health and Human Services (HHS)in cooperation with the Department of Veterans Affairs, the Department of Defense, and the Drug Enforcement Administration (DEA), to convene a Pain Management Best Practices Inter-Agency Task Force to develop and study best practices for pain management and prescription of pain medication. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program and for other purposes.
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Health Insurance Coverage, Genetic Testing (general); Health Disparities (general); Emergency Contraception (general); Health Care Reform Implementation; Drug Dependence (general); HIV Screening (general); Gynecologic Cancer (general); Gynecologic devices (general); Breast Cancer (general); Breastfeeding (general); Medical Liability Reform (general); Health IT (general); Prematurity (general); Disparities (general); Prevention and Public Health Fund (general); Maternal Mortality and Morbidity (general); Imaging (general); Graduate Medical Education (general); Quality Improvement Measurement (general); Contraception (general); Postpartum Depression (general); CMS Provider Penalties (general); Preeclampsia (general); National Health Service Corps (general); Abortion (general); Indian Health (general); Teaching Health Centers (general); Research in Pregnant and Breastfeeding Women (general); Meaningful Use Stage 3; H.R. 3940, Meaningful Use Hardship Relief Act; H.R.4695/S. 466, Quality Care for Moms and Babies Act; H.R. 3865/S.2542, Cradle Act; H.R. 836/S. 884, Health Care Safety Net Enhancement Act; H.R. 865, Good Samaritan Health Professionals Act; H.R. 2603/S. 1475, Saving Lives, Saving Costs Act; H.R. 4774, Training Tomorrows Doctors Today Act; H.R. 3658/S. 84, GEDI Act; H.R. 4771, Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016; H.R. 1209/S.628 Improving Access to Maternity Care Act; Implementation of H.R. 1462/S. 799, Protecting our Infants Act; H.R. 3691/S. 2226, Improving Treatment for Pregnant and Postpartum Women Act; H.R. 448/S.217, Women's Health Protection Act of 2015; H.R. 2972, Equal Access to Abortion Coverage in Health Insurance (EACH Woman) Act; H.Res. 461, Establishing a Select Investigative Panel of the Committee on Energy and Commerce; Fetal Tissue Research (General); H.R. 3706/S.1911, Reach Every Mother and Child Act of 2016; H.Res. 558/S.Res. 327, Condemning Violence That Targets Healthcare for Women; H.R. 4924/S.48, Prenatal Nondiscrimination Act (PRENDA) of 2016; Senate Biomedical Innovations Packages (general); S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act; S.2742, Promoting Biomedical Research and Public Health for Patients Act; H.R. 3656/S. 2100, Tobacco to 21 Act; H.R. 3652/S. 674, 21st Century Womens Health Act; S. 1532, Affordability is Access Act; H.R. 2058, FDA Deeming Authority Clarification Act of 2015; H.R. 3441, Accurate Education for Prenatal Screenings Act; H.R. 3235/S. 2311, Bringing Postpartum Depression Out of the Shadows Act; Shackling During Pregnancy (general); and H.R. 3539, Reinvigorating Antibiotic and Diagnostic Innovation Act; H.R. 5369, Healthy Start Reauthorization Act; S. 3070, Hygiene Assistance for Families of Infants and Toddlers Act of 2016; H.R. 5219 Safe Medications for Moms and Babies Act of 2016; H.R. 953/S. 524, Comprehensive Addiction and Recovery Act; H.R. 2646, Helping Families in Mental Health Crisis Act; S. 2680, Mental Health Reform Act; H.R. 3537, Synthetic Drug Control Act; H.R. 4499/S. 2758, Promoting Responsible Opioid Prescribing (PROP) Act; H.R. 4874, Prevent Abuse by Using Interstate Exchange Act; H.R. 2805/S. 1134, Heroin and Prescription Opioid Abuse, Prevention, Education, and Enforcement Act; H.R. 2654/S. 1512, Pregnant Workers Fairness Act; H.R. 1706/S.2765, Real Education for Healthy Youth Act.
Client expense: $486,704 · Firm income: Not reported
Government targets: Administration for Children & Families (ACF), Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, White House Office
2016 · second_quarter · Health Issues
S.3040, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY2017, provisions relating to NIH and drug abuse and treatment H.R.6, 21st Century Cures Act, Medical research issues. Drug abuse research and treatment related issues: S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015 S. 1622, The FDA Device Accountability Act of 2015 S. 2014, Next Generation Researchers Act S. 800, The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act S. 849, Advancing Research for Neurological Diseases Act of 2015 S. 2503, Preventing Superbugs and Protecting Patients Act S. 2511, Improving Health Information Technology S. 1878, The Advancing Hope Act of 2015 S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S. 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055, The Medical Countermeasures Innovation Act of 2015 S. 1767, The Combination Products Innovation Act of 2015 S. 1597, Patient Focused Impact Assessment Act of 2015 S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 185, Promise for Antibiotics and Therapeutics for Health Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act Opioid abuse legislation. H.R.2872, Opioid Addiction Treatment Modernization Act H.R.3537, Synthetic Drug Control Act of 2015 H.R.2536/S.1455, Recovery Enhancement for Addiction Treatment Act TREAT Act H.R.2805, Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.3014, Medical Controlled Substances Transportation Act of 2015 H.R.3716, Ensuring Terminated Providers are Removed from Medicaid and CHIP Act H.R.3821, Medicaid DOC Act H.R.2646, Helping Families in Mental Health Crisis Act of 2015 S.524, Comprehensive Addiction and Recovery Act of 2016 H.R.4396, Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2256, Co-Prescribing Saves Lives Act of 2015 S.480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.2680, Mental Health Reform Act of 2016 S.2687, Plan of Safe Care Improvement Act S.2423/H.R.4447, Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act S.1455/H.R.2536, Recovery Enhancement for Addiction Treatment Act (TREAT Act) H.R.5046, Comprehensive Opioid Abuse Reduction Act of 2016 H.R.3680, Co-Prescribing to Reduce Overdoses Act of 2016 H.R.4981, Opioid Use Disorder Treatment Expansion and Modernization Act H.R.3691, Improving Treatment for Pregnant and Postpartum Women Act of 2016 H.R.4586, Lali's Law H.R.4976, Opioid Review Modernization Act of 2016 H.R.4599, Reducing Unused Medications Act of 2016 H.R.4969, John Thomas Decker Act of 2016 H.R.4641, To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4978, NAS Healthy Babies Act H.R.3691, Improving Treatment for Pregnant and Postpartum Women Act of 2016 H.R.4229/S.36, Protecting Our Youth from Dangerous Synthetic Drugs Act of 2015
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE
2016 · first_quarter · Pharmacy
Opioid Abuse; Prescription Drugs; Pharmaceutical Innovation. HR 953 Introduced February 12, 2015 by James Sensenbrenner, JR. (R-WI) To authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use. HR 2805 Introduced July 17, 2015 by Susan Brooks (R-IN) To address prescription opioid abuse and heroin use. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend Title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2016 · first_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2016 - Provisions related to registration under the Controlled Substances Act (CSA) S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 683: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2055 - the Medical Countermeasure Innovation Act of 2015 S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2503: Preventing Superbugs and Protecting Patients Act - Provisions related to antibiotic development S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2745: Standard Merger and Acquisition Reviews Through Equal Rules Act of 2015; Motion to Recommit H.R. 2745 with Instructions - Provisions related to prescription drug costs H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3762: Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act H.R. 4365: Protecting Patient Access to Emergency Medications Act of 2016 - Provisions related to controlled substances H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Generic Drug User Fee Act (GDUFA) policy issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Antibiotics development policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner Prescription drug importation policy issues Cancer Moonshot
Client expense: $1,490,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · first_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2016 - Provisions related to registration under the Controlled Substances Act (CSA) S. 524: Comprehensive Addiction and Recovery Act of 2016 - Provisions related to opioids S. 683: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 849: Advancing Research for Neurological Diseases Act of 2016 - Provisions related to research on neurological diseases S. 1128: Preserving Access to Orphan Drugs Act of 2013 - Provisions related to orphan drug tax (113th Congress) S. 1455: Recovery Enhancement for Addiction Treatment Act - Provisions related to opioids S. 1597: Patient-Focused Impact Assessment Act of 2016 - Provisions related to patient-focused drug development S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: Combination Product Regulatory Fairness Act of 2016 - Provisions related to improvements in the regulation of combination drug-device products S. 1878: Advancing Hope Act of 2016 - Provisions related to pediatric cancer and other pediatric diseases S. 2014: Next Generation Researchers Act - Provisions related to NIH promoting new research. S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2016 - Provisions related to rare disease treatment S. 2256: Co-Prescribing Saves Lives Act of 2015 - Provisions related to co-prescribing of opioids and reversal agents S. 2388: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015 - Provisions related to reciprocity of drug approvals S. 2503: Preventing Superbugs and Protecting Patients Act - Provisions related to antibiotic development S. 2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act - Provisions related to priority review vouchers S. 2615: Increasing Competition in Pharmaceuticals Act - Provisions related to FDA review of generic drugs and study on risk evaluation and mitigation strategies (REMS) program S. 2624: National Biomedical Research Act - Provisions related to mandatory funding for NIH and FDA S. 2680: Mental Health Reform Act of 2016 - Provisions related to mental health issues S. 2689: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments S. 2700: FDA and NIH Workforce Modernization Act - Provisions related to FDA and NIH H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States (CARERS) Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2745: Standard Merger and Acquisition Reviews Through Equal Rules Act of 2015; Motion to Recommit H.R. 2745 with Instructions - Provisions related to prescription drug costs H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3762: Restoring Americans Healthcare Freedom Reconciliation Act of 2015 - Provisions related to amending and withdrawing funding from the Affordable Care Act H.R. 4365: Protecting Patient Access to Emergency Medications Act of 2016 - Provisions related to controlled substances H.R. 4762: REGROW Act - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments H.R. 4784: Lower Drug Costs Through Competition Act - Provisions related to generic drugs and priority review vouchers; REMS study; and tropical disease product applications The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act policy issues Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed rules [CMS-2390-P] Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program policy issues General FDA advocacy including sharing of truthful and non-misleading information about medicines with healthcare professionals Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biologics Price Competition and Innovation Act (BPCIA) implementation issues Generic Drug User Fee Act (GDUFA) policy issues Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Expedited drug approval policy issues Compassionate use policy issues Biosimilar approval and reimbursement policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker policy issues Policy issues related to prescription drug abuse and secure disposal Antibiotics development policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner Prescription drug importation policy issues Cancer Moonshot
Client expense: $5,950,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), Vice President of the U.S.
2016 · first_quarter · Pharmacy
Opioid Abuse; Prescription Drugs; Pharmaceutical Innovation HR 953 Introduced February 12, 2015 by James Sensenbrenner, Jr. (R-WI) To authorize the Attorney General to award grants to address the national epidemics of prescription opioid abuse and heroin use. HR 2805 Introduced July 17, 2015 by Susan Brooks (R-IN) To address prescription opioid abuse and heroin use. HR 4499 Introduced February 9, 2016 by Alex Mooney (R-VA) Promoting Responsible Opioid Prescribing Act of 2016. To amend title XVIII of the Social Security Act to remove consideration of certain pain-related issues from calculations under the Medicare hospital value-based purchasing program, and for other purposes.
Client expense: $1,940,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2016 · first_quarter · Health Issues
Issues related to the treatment of opioid addiction, including: S. 524, the Comprehensive Addiction Recovery Act (CARA) and amendments thereto; S. 1893, Mental Health Awareness and Improvement Act of 2015; H.R. 3691, Improving Treatment for Pregnant and Postpartum Women Act; H.R. 3680, Co-Prescribing to Reduce Overdoses Act of 2015; H.R. 2536/S.1455, the Recovery Enhancement for Addiction Treatment Act; H.R. 2805; the Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015; and H.R. 2872, the Opioid Addiction Treatment Modernization Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE
2016 · first_quarter · Health Issues
Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations, FY2017, provisions relating to NIH and drug abuse and treatment H.R.6, 21st Century Cures Act, Medical research issues. Drug abuse research and treatment related issues: S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015 S. 1622, The FDA Device Accountability Act of 2015 S. 2014, Next Generation Researchers Act S. 800, The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act S. 849, Advancing Research for Neurological Diseases Act of 2015 S. 2503, Preventing Superbugs and Protecting Patients Act S. 2511, Improving Health Information Technology S. 1878, The Advancing Hope Act of 2015 S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015 S. 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act S. 2055, The Medical Countermeasures Innovation Act of 2015 S. 1767, The Combination Products Innovation Act of 2015 S. 1597, Patient Focused Impact Assessment Act of 2015 S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 185, Promise for Antibiotics and Therapeutics for Health Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act Opioid abuse legislation. H.R.2872, Opioid Addiction Treatment Modernization Act H.R.3537, Synthetic Drug Control Act of 2015 H.R.2536/S.1455, Recovery Enhancement for Addiction Treatment Act TREAT Act H.R.2805, Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.3014, Medical Controlled Substances Transportation Act of 2015 H.R.3716, Ensuring Terminated Providers are Removed from Medicaid and CHIP Act H.R.3821, Medicaid DOC Act H.R.2646, Helping Families in Mental Health Crisis Act of 2015 S.524, Comprehensive Addiction and Recovery Act of 2016 H.R.4396, Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2256, Co-Prescribing Saves Lives Act of 2015 S.480, National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.2680, Mental Health Reform Act of 2016 S.2687, Plan of Safe Care Improvement Act S.2423/H.R.4447, Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE
2016 · first_quarter · Alcohol and Drug Abuse
H.R.471-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3865-Cradle Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 S.36-Protecting Our Youth from Dangerous Synthetic Drugs Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.483-Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.954-FDA Accountability for Public Safety Act S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1327-Synthetic Abuse and Labeling of Toxic Substances (SALTS) Act S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1654-Overdose Prevention Act S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2687-Plan of Safe Care Improvement Act
Client expense: $661,366 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
H.R.6-21st Century Cures Act H.R.33-Protecting Volunteer Firefighters and Emergency Responders Act H.R.290-Creating Access to Rehabilitation for Every Senior (CARES) Act of 2015 H.R.293-To amend title XI of the Social Security Act to exempt from manufacturer transparency reporting certain transfers used for educational purposes, and for other purposes. H.R.398-Trafficking Awareness Training for Health Care Act H.R.639-Improving Regulatory Transparency for New Medical Therapies Act H.R.647-Access to Life-Saving Trauma Care for All Americans Act H.R.648-Trauma Systems and Regionalization of Emergency Care Reauthorization Act H.R.836-Health Care Safety Net Enhancement Act H.R.953-Comprehensive Addiction and Recovery Act of 2015 H.R.1190-Protecting Seniors Access to Medicare Act of 2015 H.R.1571-Improving Access to Medicare Coverage Act of 2015 H.R.1641-Jason Simcakoski Memorial Opioid Safety Act H.R.1725-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 H.R.1818-Veteran Emergency Medical Technician Support Act of 2015 H.R.1821-Opioid Overdose Reduction Act of 2015 H.R.1854-Comprehensive Justice and Mental Health Act of 2015 H.R.1877-Mental Health First Aid Act of 2015 H.R.2050-Middle Class Health Benefits Tax Repeal Act of 2015 H.R.2298-Medicare Patient Safety and Drug Abuse Prevention Act H.R.2366-Field EMS Modernization and Innovation Act H.R.2463-Dispose Responsibly of your Pills (DROP) Act of 2015 H.R.2536-Recovery Enhancement for Addiction Treatment (TREAT) Act H.R.2603-Saving Lives, Saving Costs Act H.R.2646-Helping Families in Mental Health Crisis Act of 2015 H.R.2805-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 H.R.2850-Stop Overdose Stat Act of 2015 H.R.2872-Opioid Addiction Treatment Modernization Act H.R.3014-Medical Controlled Substances Transportation Act of 2015 H.R.3081-TELEmedicine for MEDicare (TELE-MED) Act of 2015 H.R.3250-DXM Abuse Prevention Act of 2015 H.R.3379-Airplane Kids In Transit Safety (KITS) Act of 2015 H.R.3537-Synthetic Drug Control Act of 2015 H.R.3677-Opioid Abuse Prevention and Treatment Act of 2015 H.R.3680-Co-Prescribing to Reduce Overdose Act of 2015 H.R.3681-Improving Access to Emergency Psychiatric Care Act H.R.3682-Reducing Employer Burdens, Unleashing Innovation, and Labor Development Act of 2015 H.R.3691-Improving Treatment for Pregnant and Postpartum Women Act of 2015 H.R.3762-Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R.3770-End Surprise Billing Act of 2015 H.R.3865-Cradle Act H.R.4059-Medicare Choices Empowerment and Protection Act H.R.4063-Promoting Responsible Opioid Management and Incorporating Scientific Expertise Act H.R.4150-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act H.R.4365-Protecting Patient Access to Emergency Medications Act of 2016 H.R.4435-Comprehensive Behavioral Health Reform and Recovery Act of 2016 H.R.4447-Opioid and Heroin Epidemic Emergency Supplemental Appropriations Act H.R.4499-Promoting Responsible Opioid Prescribing Act of 2016 H.R.4599-Reducing Unused Medications Act of 2016 H.R.4641-To provide for the establishment of an inter-agency task force to review, modify, and update best practices for pain management and prescribing pain medication, and for other purposes. H.R.4697-Prevevent Drug Addiction Act of 2016 H.R.4771-Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2016 S.141-Protecting Seniors Access to Medicare Act of 2015 S.425-Homeless Veterans' Reintegration Programs Reauthorization Act of 2015 S.453-Veteran Emergency Medical Technician Support Act of 2015 S.480-National All Schedules Prescription Electronic Reporting Reauthorization Act of 2015 S.524-Comprehensive Addiction and Recovery Act of 2015 S.599-Improving Access to Emergency Psychiatric Care Act S.636-Increasing the Safety of Prescription Drug Use Act of 2015 S.707-Opioid Overdose Reduction Act of 2015 S.711-Mental Health First Act of 2015 S.763-Trauma Systems and Regionalization of Emergency Care Reauthorization Act S.884-Health Care Safety Net Enhancement Act S.843-Improving Access to Medicare Coverage Act of 2015 S.954-FDA Accountability for Public Safety Act S.993-Comprehensive Justice and Mental Health Act of 2015 S.1134-Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 S.1392-Safer Prescribing of Controlled Substances Act S.1410-Treatment and Recovery Investment Act S.1431-Prescription Drug Abuse Prevention and Treatment Act of 2015 S.1446-SOAR to Health and Wellness Act of 2015 S.1450-Department of Veterans Affairs Emergency Medical Staffing Recruitment and Retention Act S.1452-Veterans Emergency Health Safety Net Expansion Act of 2015 S.1455-Recovery Enhancement for Addiction Treatment Act S.1475-Saving Lives, Saving Costs Act S.1549-Care Planning Act of 2015 S.1648-Rural Emergency Acute Care Hospital (REACH) Act S.1654-Overdose Prevention Act S.1693-To amend title 38, United States Code, to expand eligibility for reimbursement for emergency medical treatment to certain veterans that were unable to receive care from the Department of Veterans Affairs in the 24-month period preceding the furnishing of such emergency treatment, and for other purposes. S.1778-TELEmedicine for MEDicare (TELE-MED) Act of 2015 S.1893-Mental Health Awareness and Improvement Act of 2015 S.1913-Stopping Medication Abuse and Protecting Seniors Act of 2015 S.1945-Mental Health Reform Act of 2015 S.2002-Mental Health and Safe Communities Act of 2015 S.2045-Middle Class Health Benefits Tax Repeal Act of 2015 S.2256-Co-Prescribing Saves Lives Act of 2015 S.2297-Medicare Choices Empowerment and Protection Act S.2525-Expand Excellence in Mental Health Act S.2562-Heroin and Prescription Drug Abuse Prevention and Reduction Act S.2567-Preventing Overprescribing for Pain Act of 2016 S.2578-Reducing Unused Medications Act of 2016 S.2597-Medicare Mental Health Access Act S.2680-Mental Health Reform Act of 2016 S.2687-Plan of Safe Care Improvement Act
Client expense: $661,366 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Alcohol and Drug Abuse
Opioid Addiction issues S. 1455 - TREAT ACT, Recovery Enhancement for Addiction Act HR 1725/S. 480 - Reauthorization of NASPER - The National All Schedules Prescription Electronic Reporting Act S. 1392 Safer Prescribing of Controlled Substances Act HR 2805/S. 1134 - Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 HR 4599/S. 2578 - Reducing Unused Medications Act of 2016 - partial fill legislation Funding for demonstration projects for access to pain specialists - no specific bill DEA - change/classification of regulations regarding partial fill of prescriptions E Prescribing - schedule II drugs S. 524 - Comprehensive Addiction and Recovery Act of 2015 Draft CDC Guideline for Prescribing Opioids for Chronic Pain HR 4276/S. 2647 Behavioral Health Coverage Transparency Act SAMHSA proposed rules re: confidentiality on alcohol and drug abuse patient records, 42 CFR, Part 2 DEA Reclassification of marijuana to allow scientific research and study
Client expense: $90,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS)
2016 · first_quarter · Health Issues
PL 114 - 20 - the Medicare Access and Chip Reauthorization Act - response to RFI and proposed quality measurement plan HR 293 - the Protect Continuing Physician Education Act and Patient Care Act - regulations implementing the Sunshine Act HR 6 - 21st Century Cures - provisions impacting Sunshine Act S 320 - Medical Innovation Act - NIH funding Opioid Addiction issues S. 1455 - TREAT ACT, Recovery Enhancement for Addiction Act S. 480 - Reauthorization of NASPER - The National All Schedules Prescription Electronic Reporting Act S. 1392 Safer Prescribing of Controlled Substances Act HR 2805/S. 1134 - Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 DEA - change/classification of regulations regarding partial fill of prescriptions E Prescribing - schedule II drugs S. 524 - Comprehensive Addiction and Recovery Act of 2015 Draft CDC Guideline for Prescribing Opioids for Chronic Pain SAMHSA proposed rules re: confidentiality on alcohol and drug abuse patient records, 42 CFR, Part 2 Prescription Drug Pricing - no specific bill Funding for demonstration projects for access to pain specialists - no specific bill HR 4276/S. 2647 Behavioral Health Coverage Transparency Act HR 4599/S. 2578 - Reducing Unused Medications Act of 2016 - partial fill legislation Access to medically tailored food for low income people - no specific bill Meaningful Use and Electronic Medical Records - HR 3309 - Future Flexibility on HIT Reporting and Advancing Interoperability Act, Expand Meaningful Use Hardship Exceptions HR 2568 - Fair Medical Audits Act of 2015 DEA Reclassification of marijuana to allow scientific research and study - no specific bill Banning Nuclear War - no specific bill S. 2624 - National Biomedical Research Act Gun Violence Research - no specific bill
Client expense: $90,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS)
2015 · fourth_quarter · Health Issues
S. 122: Safe and Affordable Drugs from Canada Act of 2015 - Provisions related to importation S. 185: Promise for Antibiotics and Therapeutics for Health (PATH) Act - Provisions related to antibiotic drug approval for a limited population S. 289: American Cures Act - Provisions related to NIH funding S. 320: Medical Innovation Act of 2015 - Provisions related to National Institutes of Health (NIH) funding and covered manufacturer supplemental fees S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to Drug Enforcement Administration (DEA) scheduling S. 483: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the Controlled Substances Act (CSA) S. 683: Compassionate Access, Research Expansion, and Respect States Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research S. 1128: Preserving Access to Orphan Drugs Act - Provisions related to orphan drug tax (113th Congress) S. 1790: Safe and Affordable Prescription Drugs Act of 2015 - Provisions related to importation S. 1767: The Combination Product Regulatory Fairness Act of 2015 - Provisions related to improvements in the regulation of combination drug-device products S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to importation S. 2055 - the Medical Countermeasure Innovation Act of 2015 H.R. 6: 21st Century Cures Act - Provisions related to biopharmaceutical discovery, development, delivery and transparency H.R. 471: Ensuring Patient Access and Effective Drug Enforcement Act of 2015 - Provisions related to registration under the CSA H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to DEA scheduling H.R. 880: American Research and Competitiveness Act of 2015 - Provisions related to the research and development (R&D) tax credit H.R. 909: Andrea Sloan Compassionate Use Reform and Enhancement Act - Provisions related to expanded access H.R. 1321: Microbead-Free Waters Act of 2015 - Provisions related to bills applicability to prescription drugs H.R. 1455: Speeding Access to Already Approved Pharmaceuticals Act of 2015 - Provisions requiring FDA to expedite review of pharmaceuticals that are approved for marketing in the European Union H.R. 1537: Advancing Hope Act of 2015 - Provisions related to the pediatric rare disease voucher program H.R. 1538: Compassionate Access, Research Expansion, and Respect States Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 1576: Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015 - Provisions related to the study of regulatory challenges for the approval of complex generic drugs H.R. 1635: Charlottes Web Medical Access Act of 2015 - Provisions related to regulation of marijuana and impact on legitimate medical research H.R. 2433: To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review - Provisions regarding the enhancement of combination products review H.R. 2479: To amend the Federal Food, Drug, and Cosmetic Act to provide for the issuance of up-to-date regulations and guidance applying to the dissemination by means of the Internet of information about medical products - Provisions related to dissemination of information about medical products H.R. 2536: Recovery Enhancement for Addiction Treatment Act - Provisions related to the treatment of drug addiction H.R. 2629: Antibiotic Development to Advance Patient Treatment Act - Provisions related to the approval of certain drugs for use in a limited population of patients H.R. 2805: Heroin and Prescription Opioid Abuse Prevention, Education, and Enforcement Act of 2015 - Provisions related to the treatment of heroin and prescription opioid abuse H.R. 2820: Stem Cell Therapeutic and Research Reauthorization Act of 2015 - Provisions related to the reauthorization of the National Cord Blood Inventory program and the C.W. Bill Young Cell Transplantation Program H.R. 2841: Fair Access for Safe and Timely Generics Act of 2015 - Provisions related to requiring innovator pharmaceutical manufacturers to provide samples of risk evaluation and mitigation strategy (REMS) covered products to generic manufacturers for bioequivalence testing H.R. 2872: Opioid Addiction Treatment Modernization Act - Provisions related to the treatment of opioid addiction H.R. 3014: Medical Controlled Substances Transportation Act of 2015 - Provisions related to the transport of controlled substances by physicians in certain situations HR. 3299 - the Strengthening Public Health Emergency Response Act of 2015 H.R. 3537: Synthetic Drug Control Act of 2015 - Provisions related to amending the Controlled Substances Analogue Act and the legislative scheduling of molecules used in legitimate medical research H.R. 3680: Co-Prescribing to Reduce Overdoses Act of 2015 - Provisions related to the prescribing of opioid overdose reversal drug to at-risk patients H.R. 3762, Restoring Americans Healthcare Freedom Reconciliation Act - Provisions related to amending and withdrawing funding from the Affordable Care Act The Regenerative Medicine Regulatory Improvement Act (discussion draft) - Provisions related to creating a new regulatory pathway to speed the approval of certain stem cell treatments Kids Count Act of 2015 (discussion draft) - Provisions for incentivizing pediatric rare disease drug development ADF Incentive Act of 2015 (discussion draft) - Provisions providing manufacturers an incentive to develop abuse deterrent formulations (ADF) of controlled substances Breakpoints (discussion draft) - Provisions relating to the updating of breakpoint information for antibiotics on an FDA managed website Drug Supply Chain Security Act issues including the Charitable Donation Exemption Discussion of Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Food and Drug Administration Proposed rule: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985) - Provisions related to product labeling changes and related procedures Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules [CMS-2390-P] Provisions related to 340B program Senate HELP Committee innovation agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Proposed HRSA 340B program mega-guidance - Provisions related to 340B program Implementation issues related to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including health insurance exchanges Physician Payment Sunshine Act implementation issues, such as Open Payments System issues 340B Drug Discount Program policy issues General FDA advocacy Prescription Drug User Fee Act (PDUFA) negotiation and reauthorization Biopharmaceutical and medical innovation policy issues Drug development ecosystem policy issues Drug cost and pricing policy issues Transparency policy issues NIH Funding policy issues Precision Medicine Initiative Biomarker proposed legislation - Draft legislation related to developing a new approval pathway for biomarkers Rogue Internet Pharmacy policy issues Prescription drug abuse policy issues Drug compounding policy issues Nomination of Robert Califf to FDA Commissioner
Client expense: $380,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office