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Legislative Progress
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0
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40pct
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vs 6,526 other HR bills in the 114th — cohort avg 56d
Patient Choice Act of 2015 Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Department of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug. Defines the term “adequately safe” to mean that: (1) for at least one population, the risk of death or morbidity of the drug is unlikely to be greater than the combined risks of death or morbidity of the disease and existing therapies; or (2) the drug has had a valid marketing authorization for at least four years in one of the countries specified and data adequate for the approval of that marketing authorization has been submitted to HHS. Prohibits HHS from imposing any requirements for safety studies or data in addition to, or different than, the requirements for studies to establish safety for purposes of Phase 1 (initial introduction of an investigational new drug into humans) or Phase 2 (controlled clinical studies to evaluate the effectiveness of the drug for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug). Applies the provisional approval only to the indication for which the drug was: (1) designated as a fast track product, and (2) demonstrated to be adequately safe. Prescribes requirements for termination of provisional approval, withdrawal of provisional approval, and application of market exclusivity to fast-track approval products.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (2)
2016 · fourth_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workforces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act S. 1878, Advancing Hope Act of 2016
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Lobbying with regard to the implementation of the SMART Act (Public Law 112-242), generally. Lobbying with regard to the Medicare Secondary Payer Program, generally. S. 1514/H.R. 2649 (Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2015); provides for the application of Medicare secondary payer rules to certain workers' compensation settlement agreements and qualified Medicare set-aside provisions. Lobbying with regard to the Medicaid Third Party Liability Program, generally. S. 884/H.R. 836 (Health Care Safety Net Enhancement Act of 2015); improves access to emergency medical services, and for other purposes. H.R. 1021 (Protecting the Integrity of Medicare Act); amends Title XVIII of the Social Security Act to improve the integrity of the Medicare program, and for other purposes. H.R. 1376 (Patient Choice Act of 2015); amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast-track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. H.R. 2300 (Empowering Patients First Act of 2015); provides for incentives to encourage health insurance coverage. H.R. 2653 (American Health Care Reform Act of 2015); repeals the Patient Protection and Affordable Care Act and related reconciliation provisions, to promote patient-centered health care, to provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines. S. 2204 (End of Suffering Act of 2015); respects the Constitutional entitlement to liberty by recognizing the right of an individual to have personal control over the medical assistance and treatment necessary to avoid intolerable physical suffering. H.R.__/S.__ (Behavioral Health Information Technology Act); draft legislation amending the Public Health Service Act to include as a health care provider behavioral and mental health professionals, substance abuse professionals, psychiatric hospitals, certain community mental health centers (including one operated by a county behavioral health agency), and residential or outpatient mental health or substance abuse treatment facilities. H.R. 5403 (Ariel Grace's Law); to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. S. 2912 (Trickett Wendler Right to Try Act of 2016); to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes. H.R. 6 (21st Century Cures Act); establishing and appropriating funds, and reforming Medicaid, Medicare, and other reforms. General lobbying with regard to pharmaceutical price-gouging. H.R. 6120 (Secondary Payer Advancement, Rationalization, and Clarification (SPARC) Act); amends title XVIII of the Social Security Act to provide for clarification and rationalization of Medicare prescription drug plan recovery rules for certain claims.
Client expense: $1,150,000 · Firm income: Not reported
Government targets: Consumer Financial Protection Bureau (CFPB), Education, Dept of, Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE
2016 · third_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act S. 1878, Advancing Hope Act of 2016
Client expense: $270,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Lobbying with regard to the implementation of the SMART Act (Public Law 112-242), generally. Lobbying with regard to the Medicare Secondary Payer Program, generally. S. 1514/H.R. 2649 (Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act of 2015); provides for the application of Medicare secondary payer rules to certain workers' compensation settlement agreements and qualified Medicare set-aside provisions. Lobbying with regard to the Medicaid Third Party Liability Program, generally. S. 884/H.R. 836 (Health Care Safety Net Enhancement Act of 2015); improves access to emergency medical services, and for other purposes. H.R. 1021 (Protecting the Integrity of Medicare Act); amends Title XVIII of the Social Security Act to improve the integrity of the Medicare program, and for other purposes. H.R. 1376 (Patient Choice Act of 2015); amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast-track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. H.R. 2300 (Empowering Patients First Act of 2015); provides for incentives to encourage health insurance coverage. H.R. 2653 (American Health Care Reform Act of 2015); repeals the Patient Protection and Affordable Care Act and related reconciliation provisions, to promote patient-centered health care, to provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines. S. 2204 (End of Suffering Act of 2015); respects the Constitutional entitlement to liberty by recognizing the right of an individual to have personal control over the medical assistance and treatment necessary to avoid intolerable physical suffering. H.R.__/S.__ (Behavioral Health Information Technology Act); draft legislation amending the Public Health Service Act to include as a health care provider behavioral and mental health professionals, substance abuse professionals, psychiatric hospitals, certain community mental health centers (including one operated by a county behavioral health agency), and residential or outpatient mental health or substance abuse treatment facilities. H.R. 5403 (Ariel Grace's Law); to amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting devices. S. 2912 (Trickett Wendler Right to Try Act of 2016); to authorize the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law, and for other purposes. H.R. 6 (21st Century Cures Act); establishing and appropriating funds, and reforming Medicaid, Medicare, and other reforms.
Client expense: $1,750,000 · Firm income: Not reported
Government targets: Education, Dept of, Executive Office of the President (EOP), Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE
2016 · second_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency S. 2055, Medical Countermeasure Innovation Act of 2016 H.R. 3299, Strengthening Public Health Emergency Response Act S. 2700, FDA and NIH Workforce Authorities Modernization Act S. 2713, Advancing Precision Medicine Act of 2016 S. 2745, Advancing NIH Strategic Planning and Representation in Medical Research Act S. 2742, Promoting Biomedical Research and Public Health for Patients Act S. 3239, H.R. 5858, The RACE for Children Act S. 2689, The REGROW Act
Client expense: $280,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Lobbying with regard to the implementation of the SMART Act (Public Law 112-242), generally. Lobbying with regard to the Medicare Secondary Payer Program, generally. Lobbying with regard to the Medicare Third Party Liability Program, generally. S. 884/H.R. 836 (Health Care Safety Net Enhancement Act of 2015); improves access to emergency medical services, and for other purposes. H.R. 1021 (Protecting the Integrity of Medicare Act); amends Title XVIII of the Social Security Act to improve the integrity of the Medicare program, and for other purposes. H.R. 1376 (Patient Choice Act of 2015); amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast-track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. H.R. 2300 (Empowering Patients First Act of 2015); provides for incentives to encourage health insurance coverage. H.R. 2653 (American Health Care Reform Act of 2015); repeals the Patient Protection and Affordable Care Act and related reconciliation provisions, to promote patient-centered health care, to provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines. S. 2204 (End of Suffering Act of 2015); respects the Constitutional entitlement to liberty by recognizing the right of an individual to have personal control over the medical assistance and treatment necessary to avoid intolerable physical suffering. H.R.__/S.__ (Behavioral Health Information Technology Act); draft legislation amending the Public Health Service Act to include as a health care provider behavioral and mental health professionals, substance abuse professionals, psychiatric hospitals, certain community mental health centers (including one operated by a county behavioral health agency), and residential or outpatient mental health or substance abuse treatment facilities.
2016 · first_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative, including the following: S. 2055, The Medical Countermeasures Innovation Act of 2015; S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act; S. 2030, The Advancing Targeted Therapies for Rare Diseases Act of 2015; S. 849, Advancing Research for Neurological Diseases Act of 2015; S. 2700, FDA and NIH Workfroces Authorities Modernization Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act S. 2615, Increasing Competition in Pharmaceuticals Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues Issues related to health care transparency
2016 · first_quarter · Health Issues
Lobbying with regard to the implementation of the SMART Act (Public Law 112-242), generally. Lobbying with regard to the Medicare Secondary Payer Program, generally. Lobbying with regard to the Medicare Third Party Liability Program, generally. S. 884/H.R. 836 (Health Care Safety Net Enhancement Act of 2015); improves access to emergency medical services, and for other purposes. H.R. 1021 (Protecting the Integrity of Medicare Act); amends Title XVIII of the Social Security Act to improve the integrity of the Medicare program, and for other purposes. H.R. 1376 (Patient Choice Act of 2015); amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast-track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. H.R. 2300 (Empowering Patients First Act of 2015); provides for incentives to encourage health insurance coverage. H.R. 2653 (American Health Care Reform Act of 2015); repeals the Patient Protection and Affordable Care Act and related reconciliation provisions, to promote patient-centered health care, to provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines. S. 2204 (End of Suffering Act of 2015); respects the Constitutional entitlement to liberty by recognizing the right of an individual to have personal control over the medical assistance and treatment necessary to avoid intolerable physical suffering. H.R.__/S.__ (Behavioral Health Information Technology Act); draft legislation amending the Public Health Service Act to include as a health care provider behavioral and mental health professionals, substance abuse professionals, psychiatric hospitals, certain community mental health centers (including one operated by a county behavioral health agency), and residential or outpatient mental health or substance abuse treatment facilities.
2015 · fourth_quarter · Health Issues
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B issues and legislative reform proposals Issues related to importation of prescription drugs, including those contained in S. 122, Safe and Affordable Drugs from Canada Act of 2015 Health technology assessment of orphan drugs Sequestration of FDA user fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures/Innovation initiatives including H.R. 6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases Issues and policies related to implementation of Orphan Drug Act and orphan drug development S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of newborn screening programs Issues and policies related to biosimilars exclusivity period Issues and policies related to biosimilars FDA guidance Issues and policies related to FDA oversight and management Issues and policies related to expanded access programs Issues and policies related to patient involvement with FDA decision making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to FDA priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023, Prescription Drug Affordability Act of 2015 Drug shortage issues
2015 · fourth_quarter · Health Issues
Lobbying with regard to the implementation of the SMART Act (Public Law 112-242), generally. Lobbying with regard to the Medicare Secondary Payer Program, generally. Lobbying with regard to the Medicare Third Party Liability Program, generally. S. 884/H.R. 836 (Health Care Safety Net Enhancement Act of 2015); improves access to emergency medical services, and for other purposes. H.R. 1021 (Protecting the Integrity of Medicare Act); amends Title XVIII of the Social Security Act to improve the integrity of the Medicare program, and for other purposes. H.R. 1376 (Patient Choice Act of 2015); amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast-track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. H.R. 2300 (Empowering Patients First Act of 2015); provides for incentives to encourage health insurance coverage. H.R. 2653 (American Health Care Reform Act of 2015); repeals the Patient Protection and Affordable Care Act and related reconciliation provisions, to promote patient-centered health care, to provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines. S. 2204 (End of Suffering Act of 2015); respects the Constitutional entitlement to liberty by recognizing the right of an individual to have personal control over the medical assistance and treatment necessary to avoid intolerable physical suffering.
Client expense: $1,600,000 · Firm income: Not reported
2015 · third_quarter · Health Issues
Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B Issues and Legislative Reform Proposals Drug Shortage Issues Health Technology Assessment of Orphan Drugs Sequestration of FDA User Fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures Initiative including H.R.6, 21st Century Cures Act and the Innovation for Healthier Americans Initiative H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases. Implementation of Orphan Drug Act and Orphan Drug Development S. 122, Safe and Affordable Drugs from Canada Act of 2015 S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531 and S.1878, Advancing Hope Act of 2015 Implementation of Newborn Screening Programs Biosimilars Exclusivity Period Biosimilars FDA Guidance FDA Oversight and Management Expanded Access Programs Patient Involvement with FDA Decision Making S. 289 and H.R. 2104, American Cures Act Legislation pertaining to priority review vouchers, generally Legislation pertaining to the applicability of the ACA tax carve out for non-orphan drug designated drugs, generally, including H.R. 3678, Preserving Access to Orphan Drugs Act of 2015 H.R. 3618 and S. 1906, Orphan Drug Fairness Act Issues related to the value of prescription medicines, generally, and including S. 2023,Prescription Drug Affordability Act of 2015
2015 · third_quarter · Health Issues
Lobbying with regard to the implementation of the SMART Act (Public Law 112-242), generally. Lobbying with regard to the Medicare Secondary Payer Program, generally. Lobbying with regard to the Medicare Third Party Liability Program, generally. S. 884/H.R. 836 (Health Care Safety Net Enhancement Act of 2015); improves access to emergency medical services, and for other purposes. H.R. 1021 (Protecting the Integrity of Medicare Act); amends Title XVIII of the Social Security Act to improve the integrity of the Medicare program, and for other purposes. H.R. 1376 (Patient Choice Act of 2015); amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast-track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. H.R. 2300 (Empowering Patients First Act of 2015); provides for incentives to encourage health insurance coverage. H.R. 2653 (American Health Care Reform Act of 2015); repeals the Patient Protection and Affordable Care Act and related reconciliation provisions, to promote patient-centered health care, to provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines. S. __ (End of Suffering Act of 2015); draft bill not introduced as of 10-20-2015; respects the Constitutional entitlement to liberty by recognizing the right of an individual to have personal control over the medical assistance and treatment necessary to avoid intolerable physical suffering.
Client expense: $1,520,000 · Firm income: Not reported
2015 · second_quarter · Health Issues
Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B Issues and Legislative Reform Proposals Drug Shortage Issues Health Technology Assessment of Orphan Drugs Sequestration of FDA User Fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures Initiative including H.R.6, 21st Century Cures Act H.R. 909, Andrea Sloan CURE Act S. 1421 and H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases. Implementation of Orphan Drug Act and Orphan Drug Development S. 122, Safe and Affordable Drugs from Canada Act of 2015 S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531, Advancing Hope Act of 2015 Implementation of Newborn Screening Programs Biosimilars Exclusivity Period Biosimilars FDA Guidance FDA Oversight and Management Expanded Access Programs Patient Involvement with FDA Decision Making S. 289 and H.R. 2104, American Cures Act
Client expense: $260,000 · Firm income: Not reported
2015 · second_quarter · Health Issues
Lobbying with regard to the implementation of the SMART Act (Public Law 112-242), generally. Lobbying with regard to the Medicare Secondary Payer Program, generally. Lobbying with regard to the Medicare Third Party Liability Program, generally. H.R. 1982 (Medicare Secondary Payer and Workers' Compensation Settlement Agreements Act); amends Title XVIII (Medicare) of the Social Security Act to: (1) create an exception to Medicare secondary payer requirements for certain workers' compensation settlement agreements and (2) provide for the satisfaction of such requirements through use of qualified Medicare set-asides under workers' compensation settlement agreements. S. 884/H.R. 836 (Health Care Safety Net Enhancement Act of 2015); improves access to emergency medical services, and for other purposes. H.R. 1021 (Protecting the Integrity of Medicare Act); amends Title XVIII of the Social Security Act to improve the integrity of the Medicare program, and for other purposes. H.R. 1376 (Patient Choice Act of 2015); amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast-track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. H.R. 2300 (Empowering Patients First Act of 2015); provides for incentives to encourage health insurance coverage. H.R. 2653 (American Health Care Reform Act of 2015); repeals the Patient Protection and Affordable Care Act and related reconciliation provisions, to promote patient-centered health care, to provide for the creation of a safe harbor for defendants in medical malpractice actions who demonstrate adherence to clinical practice guidelines. S. __ (End of Suffering Act of 2015); draft bill not introduced as of 7-17-2015; respects the Constitutional entitlement to liberty by recognizing the right of an individual to have personal control over the medical assistance and treatment necessary to avoid intolerable physical suffering.
2015 · first_quarter · Health Issues
Implementation of P.L. 111-148, Patient Protection & Affordable Health Care Act and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152) 340B Issues Drug Shortage Issues Health Technology Assessment of Orphan Drugs Sequestration of FDA User Fees H.R. 1376, Patient Choice Act of 2015 H.R. 790, Compassionate Freedom of Choice Act of 2015 H.R. 1600, Patients' Access to Treatments Act of 2015 21st Century Cures Initiative H.R. 909, Andrea Sloan CURE Act H.R.971, Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Implementation of the FDA Safety and Innovation Act (FDASIA) (Pub. L. 112-144) Regulation of innovative biological products for neurodegenerative diseases. Implementation of Orphan Drug Act and Orphan Drug Development S. 122, Safe and Affordable Drugs from Canada Act of 2015 S. 320, Medical Innovation Act H.R. 744, Medical Innovation Act H.R. 1130, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 S. 598, Chronic Kidney Disease Improvement in Research and Treatment Act of 2015 H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015 H.R. 1531, Advancing Hope Act of 2015 Implementation of Newborn Screening Programs Biosimilars Exclusivity Period Biosimilars FDA Guidance FDA Oversight and Management Expanded Access Programs Patient Involvement with FDA Decision Making H.R. 1078, Food and Drug Administration Safety Over Sequestration Act of 2015
Client expense: $270,000 · Firm income: Not reported
Client expense: $1,500,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Vice President of the U.S.
Client expense: $290,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Client expense: $1,380,000 · Firm income: Not reported
Government targets: Consumer Financial Protection Bureau (CFPB), Education, Dept of, Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), Office of the Vice President of the United States, SENATE, Vice President of the U.S.
Client expense: $260,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Government targets: Consumer Financial Protection Bureau (CFPB), Consumer Product Safety Commission (CPSC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
Client expense: $235,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Government targets: Consumer Financial Protection Bureau (CFPB), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
Client expense: $1,410,000 · Firm income: Not reported
Government targets: Consumer Financial Protection Bureau (CFPB), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE