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Legislative Progress
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0
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97pct
346d open
vs 6,526 other HR bills in the 114th — cohort avg 56d
(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.) DXM Abuse Prevention Act of 2015 (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of a drug containing dextromethorphan (DXM, a cough suppressant and drug of abuse) to an individual under age 18 unless the individual has a prescription or is actively enrolled in the military. Retailers selling DXM must implement a verification system to ensure compliance. Civil monetary penalties that escalate upon repeated violation are imposed. (Sec. 3) Unfinished DXM may only be possessed by, distributed to, and received by persons registered with the Food and Drug Administration as producers of a drug or medical device or otherwise allowed to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients. Common carriers distributing unfinished DXM between authorized persons are exempted. Civil monetary penalties are imposed for possession and distribution violations.
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Filing registrants (18)
Placed on the Union Calendar, Calendar No. 520.
Reported by the Committee on Energy and Commerce. H. Rept. 114-672.
Congress.gov source codes: 5000, H12200
Ordered to be Reported by Voice Vote.
Committee Consideration and Mark-up Session Held.
Committee Consideration and Mark-up Session Held.
Committee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee by Voice Vote .
Subcommittee Consideration and Mark-up Session Held.
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2017 · third_quarter · Health Issues
H.R.3250, DXM Abuse Prevention Act of 2015; OTC Monograph Modernization; S.1113, Personal Care Products Safety Act.
Client expense: Not reported · Firm income: $50,000
Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Health Issues
H.R.3250 - DXM Abuse Prevention Act of 2015; OTC Monograph Modernization.
Client expense: Not reported · Firm income: $40,000
Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE
2017 · first_quarter · Health Issues
H.R.3250 - DXM Abuse Prevention Act of 2015; OTC Monograph Modernization.
Client expense: Not reported · Firm income: $40,000
Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE
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
Congress.gov source codes: 1000, Intro-H
| Democratic |
| IA |
| Doris O. Matsui | Democratic | CA |
| Eleanor Holmes Norton | Democratic | DC |
| Erik Paulsen | Republican | MN |
| Jared Huffman | Democratic | CA |
| John Katko | Republican | NY |
| Julia Brownley | Democratic | CA |
| Lou Barletta | Republican | PA |
| Mark DeSaulnier | Democratic | CA |
| Michael C. Burgess | Republican | TX |
| Michael G. Fitzpatrick | Republican | PA |
| Patrick Meehan | Republican | PA |
| Paul Tonko | Democratic | NY |
| Pete Olson | Republican | TX |
| Ron Kind | Democratic | WI |
| Ryan A. Costello | Republican | PA |
| Yvette D. Clarke | Democratic | NY |
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 · 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. 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. 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. 1270 - Restoring Access to Medication and Improving Health Savings Act of 2016 - FSA and HSA use for over the counter medication 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. 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 - age requirement for purchase of OTC medication including dextromethorphan Monograph reform 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: $492,000 · 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), SENATE, U.S. Trade Representative (USTR)
2016 · fourth_quarter · Health Issues
- H 2, "Medicare Access and CHIP Reauthorization Act of 2015", regarding all provisions. - HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - S 1622, "FDA Device Accountability Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - S 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues relating to cosmetic regulatory reform. - Issues related to 340B payments to hospitals. - Issues related to pseudoephedrine. - Issues related to dextromethorphan. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - S.2977, "The Medical Electronic Data Technology Enhancement for Consumers' Health" (MEDTECH Act), regarding all provisions. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 2994, "DXM Abuse Prevention Act of 2016", regarding all provisions. - S. 1767, "The Combination Products Regulatory Fairness Act of 2015", regarding all provisions. - HR 2646, "Helping Families in Mental Health Crisis Act of 2015", regarding all provisions. - HR 1854, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - S. 1014, "Personal Care Products Safety Act", regarding all provisions. - S. 2777, "Contact lens Consumer Health Protection Act of 2016", regarding all provisions. - Issues related to Medicare Part B Demo - Issues related to Expanded Access in Senate Innovation Package - Issues related to Self monitoring of blood glucose meters. - HR 4075, "Cosmetic Modernization Amendments of 2015", regarding all provisions. - HR 1192, "National Clinical Care Commission Act", regarding all provisions.
Client expense: $1,460,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · fourth_quarter · Pharmacy
H.R.3250/S. 2994 - DXM Abuse Prevention Act of 2015 H.R. 1270 / S. 620 - Restore Access to Medication Act H.R. 592 / S. 314 - Pharmacy and Medically Underserved Areas Enhancement Act H.R.3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R. 793/S. 1190 - the Ensuring Seniors Access to Local Pharmacies Act Health Savings Act of 2016 - H.R.4469/S.2499 H.R. 5951/S. 3308 - Improving Transparency and Accuracy in Medicare Part D Spending Act
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
- H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015, regarding all provisions. - H.R. 6 - 21st Century Cures Act (P.L. 114-255), regarding all provisions. - Issues relating to cosmetic regulatory reform. - Issues related to pseudoephedrine. - Issues related Fairness to Contact Lens Consumers Act (P.L. 108-164) and related FTC Contact Lens Rule. - H.R. 3250 - DXM Abuse Prevention Act of 2015, regarding all provisions. - S. 2994 - DXM Abuse Prevention Act of 2016, regarding all provisions. - S. 1014 - Personal Care Products Safety Act of 2015, regarding all provisions. - S. 277 - Contact lens Consumer Health Protection Act of 2016, regarding all provisions. - S 697 - Frank R. Lautenberg Chemical Safety for the 21st Century Act, regarding all provisions. - H.R. 2858 - Humane Cosmetics Act, regarding all provisions.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
HR 2712 Commonsense Reporting and Verification Act of 2015 S 1996 Common Sense Reporting Act HR 3250 DXM Abuse Prevention Act of 2015
Client expense: $40,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
- H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015, regarding all provisions. - H.R. 6 - 21st Century Cures Act (P.L. 114-255), regarding all provisions. - Issues relating to cosmetic regulatory reform. - Issues related to pseudoephedrine. - Issues related Fairness to Contact Lens Consumers Act (P.L. 108-164) and related FTC Contact Lens Rule. - H.R. 3250 - DXM Abuse Prevention Act of 2015, regarding all provisions. - S. 2994 - DXM Abuse Prevention Act of 2016, regarding all provisions. - S. 1014 - Personal Care Products Safety Act of 2015, regarding all provisions. - S. 277 - Contact lens Consumer Health Protection Act of 2016, regarding all provisions. - S 697 - Frank R. Lautenberg Chemical Safety for the 21st Century Act, regarding all provisions. - H.R. 2858 - Humane Cosmetics Act, regarding all provisions.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
- H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015, regarding all provisions. - H.R. 6 - 21st Century Cures Act (P.L. 114-255), regarding all provisions. - Issues relating to cosmetic regulatory reform. - Issues related to pseudoephedrine. - Issues related Fairness to Contact Lens Consumers Act (P.L. 108-164) and related FTC Contact Lens Rule. - H.R. 3250 - DXM Abuse Prevention Act of 2015, regarding all provisions. - S. 2994 - DXM Abuse Prevention Act of 2016, regarding all provisions. - S. 1014 - Personal Care Products Safety Act of 2015, regarding all provisions. - S. 277 - Contact lens Consumer Health Protection Act of 2016, regarding all provisions. - S 697 - Frank R. Lautenberg Chemical Safety for the 21st Century Act, regarding all provisions. - H.R. 2858 - Humane Cosmetics Act, regarding all provisions.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Consumer Issues/Safety/Products
FDA regulation of cosmetics. Consumer product safety issues. H.R. 1139 and S. 588, Detergent PACS Act of 2015. H.R. 3250, DXM Abuse Prevention Act of 2015.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Pharmacy
- Dextromethorphan Abuse Reduction - HR 3250, DXM Abuse Prevention Act of 2015 - Regulation of OTC drugs, devices and cosmetics - HR 4075, Cosmetic Modernization Amendments of 2015 - S.1014, The Personal Care Products Safety Act
Client expense: $779,741 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)
2016 · fourth_quarter · Alcohol and Drug Abuse
Dextromethorphan H.R. 3250/S. 2994, the "DXM Abuse Prevention Act" (DAP) - legislation that would ban the sale of over-the-counter cough and cold medications containing the active ingredient dextromethorphan (DXM) to minors under the age of 18. Additionally, would ban the sale of bulk, unfinished DXM to entities not registered with the U.S. Food and Drug Administration; all sections.
Client expense: $370,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of
2016 · fourth_quarter · Alcohol and Drug Abuse
H.R. 471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524 - Comprehensive Addiction and Recovery Act of 2016 H.R.953 - Comprehensive Addiction and Recovery Act of 2015 HR 3250 - DXM Abuse Prevention Act S. 2294 - DXM Abuse Prevention Act H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 H.R.4931 - Pharmaceutical Stewardship Act of 2016 S. 3075 - Addiction Prevention and Responsible Opioid Practices Act
Client expense: $380,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R. 3250: DXM Abuse Prevention Act of 2015. Education about FDA regulation of over the counter medicines.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Pharmacy
H.R. 592/S. 314, Pharmacy and Medically Underserved Areas Enhancement Act, all provisions. H.R. 4909, FY 2017 National Defense Authorization Act, provisions related to TRICARE and pharmacy access. H.R. 953/S. 524, Comprehensive Addition and Recovery Act, provisions related to state prescription drug monitoring programs. H.R. 793/S. 1190, Ensuring Seniors Access to Local Pharmacies Act of 2015, all provisions. H.R. 3250, DXM Abuse Prevention Act, provisions related to retail pharmacy.
Client expense: $220,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Alcohol and Drug Abuse
Issues related to the sale of medicines that contain dextromethorphan, including H.R.3250 and S.2994, the DXM Abuse Prevention Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R.3250 - DXM Abuse Prevention Act of 2015; OTC Monograph Modernization.
Client expense: Not reported · Firm income: $40,000
Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE
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 · Pharmacy
- Dextromethorphan Abuse Reduction - HR 3250, DXM Abuse Prevention Act of 2015 - Regulation of OTC drugs, devices and cosmetics - HR 4075, Cosmetic Modernization Amendments of 2015 - S.1014, The Personal Care Products Safety Act
Client expense: $721,244 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)
2016 · third_quarter · Pharmacy
H.R.3250/S. 2994 - DXM Abuse Prevention Act of 2015 H.R. 1270 / S. 620 - Restore Access to Medication Act H.R. 592 / S. 314 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 2029 - Consolidated Appropriations Act, House Amendments 1 and 2 to Senate Amendment published as Rules Committee Prints 114-39 and 114-40 H.R.3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R. 793/S. 1190 - the Ensuring Seniors Access to Local Pharmacies Act Health Savings Act of 2016 - H.R.4469/S.2499 H.R. 5951/S. 3308 - Improving Transparency and Accuracy in Medicare Part D Spending Act
Client expense: $150,000 · 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
- H 2, "Medicare Access and CHIP Reauthorization Act of 2015", regarding all provisions. - HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - S 1622, "FDA Device Accountability Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - S 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues relating to cosmetic regulatory reform. - Issues related to 340B payments to hospitals. - Issues related to pseudoephedrine. - Issues related to dextromethorphan. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - S.2977, "The Medical Electronic Data Technology Enhancement for Consumers' Health" (MEDTECH Act), regarding all provisions. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 2994, "DXM Abuse Prevention Act of 2016", regarding all provisions. - S. 1767, "The Combination Products Regulatory Fairness Act of 2015", regarding all provisions. - HR 2646, "Helping Families in Mental Health Crisis Act of 2015", regarding all provisions. - HR 1854, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - S. 1014, "Personal Care Products Safety Act", regarding all provisions. - S. 277, "Contact lens Consumer Health Protection Act of 2016", regarding all provisions. - Issues related to Medicare Part B Demo - Issues related to Expanded Access in Senate Innovation Package - Issues related to Self monitoring of blood glucose meters. - HR 4075, "Cosmetic Modernization Amendments of 2015", regarding all provisions.
Client expense: $890,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · third_quarter · Alcohol and Drug Abuse
H.R. 471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015 S.524 - Comprehensive Addiction and Recovery Act of 2016 H.R.953 - Comprehensive Addiction and Recovery Act of 2015 HR 3250 - DXM Abuse Prevention Act S. 2294 - DXM Abuse Prevention Act H.R. 5046 - Comprehensive Opioid Abuse Reduction Act of 2016 H.R.4931 - Pharmaceutical Stewardship Act of 2016 S. 3075 - Addiction Prevention and Responsible Opioid Practices Act
Client expense: $920,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
H.R. 3250: DXM Abuse Prevention Act of 2015. S.524: Comprehensive Addiction and Recovery Act of 2016, as it relates to Rx take back programs. Education about FDA regulation of over the counter medicines.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
- HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - Issues relating to cosmetic regulatory reform. - Issues related to pseudoephedrine. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 2994, "DXM Abuse Prevention Act of 2016", regarding all provisions. - S. 1014, "Personal Care Products Safety Act", regarding all provisions. - S. 277, "Contact lens Consumer Health Protection Act of 2016", regarding all provisions. - S 697, "Frank R. Lautenberg Chemical Safety for the 21st Century Act", regarding all provisions. - HR 2858, "Humane Cosmetics Act", regarding all provisions.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Alcohol and Drug Abuse
Issues related to the sale of medicines that contain dextromethorphan, including H.R.3250 and S.2994, the DXM Abuse Prevention Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Consumer Issues/Safety/Products
FDA regulation of cosmetics. Consumer product safety issues. H.R. 1139 and S. 588, Detergent PACS Act of 2015. H.R. 3250, DXM Abuse Prevention Act of 2015. S. 697, Frank R. Lautenberg Chemical Safety for the 21st Century Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Pharmacy
H.R. 592/S. 314, Pharmacy and Medically Underserved Areas Enhancement Act, all provisions. H.R. 4909, FY 2017 National Defense Authorization Act, provisions related to TRICARE and pharmacy access. H.R. 953/S. 524, Comprehensive Addition and Recovery Act, provisions related to state prescription drug monitoring programs. H.R. 793/S. 1190, Ensuring Seniors Access to Local Pharmacies Act of 2015, all provisions. H.R. 3250, DXM Abuse Prevention Act, provisions related to retail pharmacy.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
HR 2712 Commonsense Reporting and Verification Act of 2015 S 1996 Common Sense Reporting Act HR 3250 DXM Abuse Prevention Act of 2015
Client expense: $40,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Alcohol and Drug Abuse
H.R. 471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015; S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015; Implementation of Public Law 114-198; S.524 - Comprehensive Addiction and Recovery Act of 2016; H.R.953 - Comprehensive Addiction and Recovery Act of 2015; H.R. 3250 - DXM Abuse Prevention Act; H.R. 5951/S. 3308 - Improving Transparency and Accuracy in Medicare Part D Spending Act
Client expense: $335,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE
2016 · third_quarter · Alcohol and Drug Abuse
Dextromethorphan H.R. 3250/S. 2994, the "DXM Abuse Prevention Act" (DAP) - legislation that would ban the sale of over-the-counter cough and cold medications containing the active ingredient dextromethorphan (DXM) to minors under the age of 18. Additionally, would ban the sale of bulk, unfinished DXM to entities not registered with the U.S. Food and Drug Administration; all sections.
Client expense: $290,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of
2016 · third_quarter · Health Issues
H.R.3250 - DXM Abuse Prevention Act of 2015; OTC Monograph Modernization.
Client expense: Not reported · Firm income: $40,000
Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, 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 · Health Issues
HR 2712 Commonsense Reporting and Verification Act of 2015 S 1996 Common Sense Reporting Act HR 3250 DXM Abuse Prevention Act of 2015
Client expense: $40,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2016 · second_quarter · Pharmacy
H.R.3250/S. 2994 - DXM Abuse Prevention Act of 2015 H.R. 1270 / S. 620 - Restore Access to Medication Act H.R. 592 / S. 314 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 2029 - Consolidated Appropriations Act, House Amendments 1 and 2 to Senate Amendment published as Rules Committee Prints 114-39 and 114-40 H.R.3762 - Restoring Americans' Healthcare Freedom Reconciliation Act of 2015 H.R. 793/S. 1190 - the Ensuring Seniors Access to Local Pharmacies Act Health Savings Act of 2016 - H.R.4469/S.2499
Client expense: $280,000 · 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. 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 · Alcohol and Drug Abuse
H.R. 471 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015; S. 483 - Ensuring Patient Access and Effective Drug Enforcement Act of 2015; S.524 - Comprehensive Addiction and Recovery Act of 2016; H.R.953 - Comprehensive Addiction and Recovery Act of 2015; H.R. 3250 - DXM Abuse Prevention Act;
Client expense: $390,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE
2016 · second_quarter · Health Issues
- H 2, "Medicare Access and CHIP Reauthorization Act of 2015", regarding all provisions. - HR 1078, "Food and Drug Administration Safety Over Sequestration Act of 2015", regarding all provisions. - S 1622, "FDA Device Accountability Act of 2015", regarding all provisions. - HR 6, "21st Century Cures Act", regarding all provisions. - S 993, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - Issues related to physician-owned companies that manufacture or distribute medical devices. - Issues relating to cosmetic regulatory reform. - Issues related to 340B payments to hospitals. - Issues related to pseudoephedrine. - Issues related to dextromethorphan. - Issues related to legislation that would modify the Medicare Part B drug reimbursement program. - Issues related to legislation that would establish a rebate in the Medicare Part D program. - Issues related to Pub.L. 108-164, "Fairness to Contact Lens Consumers Act" (FCLCA) and related FTC Contact Lens Rule. - S.2977, "The Medical Electronic Data Technology Enhancement for Consumers' Health" (MEDTECH Act), regarding all provisions. - H.R. 3250, "DXM Abuse Prevention Act of 2015", regarding all provisions. - S. 2994, "DXM Abuse Prevention Act of 2016", regarding all provisions. - S. 1767, "The Combination Products Regulatory Fairness Act of 2015", regarding all provisions. - HR 2646, "Helping Families in Mental Health Crisis Act of 2015", regarding all provisions. - HR 1854, "Comprehensive Justice and Mental Health Act of 2015", regarding all provisions. - S. 1014, "Personal Care Products Safety Act", regarding all provisions. - S. 277, "Contact lens Consumer Health Protection Act of 2016", regarding all provisions. - Issues related to Medicare Part B Demo - Issues related to Expanded Access in Senate Innovation Package
Client expense: $2,040,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
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 · Pharmacy
- Dextromethorphan Abuse Reduction - HR 3250, DXM Abuse Prevention Act of 2015 - Regulation of OTC drugs, devices and cosmetics - HR 1321 / S.1424, Microbead Free Waters Act of 2015 - HR 4075, Cosmetic Modernization Amendments of 2015 - S.1014, The Personal Care Products Safety Act
Client expense: $783,084 · Firm income: Not reported
Government targets: Bureau of Citizenship & Immigration Services (BCIS), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)
2016 · second_quarter · Health Issues
Issues related to the global health care supply chain including the implementation of unique device identifiers requirements, and the Drug Supply Chain Security Act. Issues related to the sale of medicines that contain dextromethorphan, including H. R. 3250 the DXM Abuse Prevention Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR)
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 · Consumer Issues/Safety/Products
FDA regulation of cosmetics. Consumer product safety issues. H.R. 1139 and S. 588, Detergent PACS Act of 2015. H.R. 3250, DXM Abuse Prevention Act of 2015. S. 697, Frank R. Lautenberg Chemical Safety for the 21st Century Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
H.R.3250 - DXM Abuse Prevention Act of 2015; OTC Monograph Modernization.
Client expense: Not reported · Firm income: $30,000
Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
H.R. 3250: DXM Abuse Prevention Act of 2015. S.524: Comprehensive Addiction and Recovery Act of 2016, as it relates to Rx take back programs. Education about FDA regulation of over the counter medicines.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE