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Legislative Progress
Introduced
February 27, 2017
Latest Action
February 27, 2017
Primary Sponsor
Michael F. BennetDemocratic(CO)
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
0pct
0d open
vs 3,805 other S bills in the 115th — cohort avg 41d
Research to Accelerate Cures and Equity for Children Act or the RACE for Children Act This bill amends the Federal Food, Drug, and Cosmetic Act to expand Food and Drug Administration (FDA) requirements for sponsors of certain drugs and biological products for adult cancer to assess the use of their medications in pediatric populations. (Currently, applications for FDA approval of new medications or new uses of medications must include pediatric assessments of safety and effectiveness for claimed indications, with exceptions.) The pediatric assessment for medications, including orphan drugs, that are used to treat cancer in adults and target a molecule germane to pediatric cancer must assess the safety and effectiveness of the medication for pediatric cancer. The bill limits waivers of pediatric assessments for medications that target a molecule germane to a pediatric cancer for which there is a need for additional treatment options. The FDA may require the sponsor of an approved medication that targets a molecule germane to pediatric cancer to complete a pediatric assessment if: (1) the medication is used for a substantial number of pediatric cancer patients, or (2) there is reason to believe the medication would have a meaningful therapeutic benefit over existing therapies for pediatric cancer patients. The FDA committee that reviews requests for pediatric studies must implement a plan to achieve earlier submission of pediatric studies. (Currently, completion of pediatric clinical studies requested by the FDA extends the patents or marketing exclusivity period for a medication by six months, with exceptions.) The FDA must act within 120 days on proposed pediatric study requests and proposed amendments to requests.
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 (25)
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2018 · first_quarter · Health Issues
Issues relating to health disparities, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including: H.R.1676 & S.693, the Palliative Care and Hospice Education and Training Act; the Breast Density & Mammography Reporting Act; H.R.820 & S.292, Childhood Cancer STAR Act; and, H.R. 1231 & S. 456, the RACE for Children Act. In addition, the discussion draft of The Diagnostic Accuracy and Innovation Act; and H.R.772 and S.261, the Common Sense Nutrition Disclosure Act. Preservation of the Prevention and Public Health Fund and reauthorization of the CHIP program and FQHCs respecting H.R. 3922. Issues relating to anti-cancer medication cost-sharing parity respecting H.R. 1409. Issues regarding a national family caregiving strategy respecting S. 1719 and H.R. 1028. Issues regarding access to medicines respecting S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, as well as H.R.878, the Right to Try Act of 2017. Issues regarding lymphedema treatment respecting The Lymphedema Treatment Act, H.R. 930 and S. 497. Issues regarding access to care respecting the Bi-partisan Health Care Stabilization Act (Alexander-Murray) and S 1835, The Lower Premiums through Reinsurance Act.
Client expense: $650,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
2018 · fourth_quarter · Medical/Disease Research/Clinical Labs
Legislation and policies related to: Pediatric and childrens health research Nursing research Draft legislation to reauthorize and modernize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 2430/S. 934 - FDA Reauthorization Act of 2017 S. 292/H.R. 820 - Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act of 2017 S. 456/H.R. 1231 - Research to Accelerate Cures and Equity (RACE) for Children Act
Client expense: Not reported · Firm income: $23,450
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)
2018 · fourth_quarter · Health Issues
H.R.1409 - Cancer Drug Parity Act of 2017 H.R.820/ S. 292 - Childhood Cancer STAR Act H.R.1231/S. 456 - RACE for Children Act H.R.1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R.878 - Right to Try Act of 2017 S.204 - Trickett Wendler Right to Try Act of 2017 H.R.1854/ S. 778 - Prescription Drug Monitoring Act of 2017 Diagnostic Accuracy and Innovation Act (DAIA)(Draft legislation) H.R. 2430 FDA Reauthorization Act S. 934 FDA Reauthorization Act H.R. 2797/ S.1334Patient Choice and Quality Care Act (PCQCA) H.R. 2999Patient's Access to Treatment Act (PATA) H.R. 1628Better Care Reconciliation Act (BCRA) H.R. 1316Prescription Drug Pricing Transparency Act H.R. 2077 Restoring Patients Voices Act
Client expense: $79,366 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Client expense: $580,000 · Firm income: Not reported
2018 · fourth_quarter · Health Issues
FDA - rare and orphan disease issues; Prescription drug coverage and payment policies; Medical innovation issues; H.R. 1231/S. 456 - Research to Accelerate Cures and Equity for Children Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Republican |
| FL |
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill, Raising Awareness of Cystic Fibrosis ***, no specific bill, appropriations for the Department of Health and Human Services, PDUFA, Sunshine, Orphan drugs, 340B, Innovation, EXPERT, Non-interference, drug development policies
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 no specific bills: Innovation, Duchenne Muscular Dystrophy, platform technologies, non-interference
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 878/S. 204 - Right to Try Act H.R. 1231/S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 849/S. 260 - Protecting Seniors' Access to Medicare Act S. 2852 - Pandemic and All Hazards Preparedness Act S.2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act H.R. 6 - SUPPORT for Patients and Communities Act ***no specific bills, importation, supply chain integrity, 304b, biosimilars, orphan drugs, newborn screening, expanded access, priority review, transparency, drug shortages, IPAB
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 456 - RACE for Children Act S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act no specific bills, 340B, Innovation, Transparency, Precision Medicine, NIH, Importation, Non-Interference, Vaccines, Biosimilars, Compounding
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Cost Through Competition Act H.R. 1231/S. 456 - RACE for Children Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bills; user fee reauthorization, non-interference, dormant therapies, drug shortages, prescription drug access and affordability
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act S. 2852 - Pandemic and All Hazards Preparedness Act ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, Innovation, 340B, comparative effectiveness research, user fee reauthorization, non-interference, IPAB
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2018 · third_quarter · Medical/Disease Research/Clinical Labs
Legislation and policies related to: Pediatric and childrens health research Nursing research Draft legislation to reauthorize and modernize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 2430/S. 934 - FDA Reauthorization Act of 2017 S. 292/H.R. 820 - Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act of 2017 S. 456/H.R. 1231 - Research to Accelerate Cures and Equity (RACE) for Children Act
Client expense: Not reported · Firm income: $23,450
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)
2018 · third_quarter · Health Issues
H.R.1409 - Cancer Drug Parity Act of 2017 H.R.820/ S. 292 - Childhood Cancer STAR Act H.R.1231/S. 456 - RACE for Children Act H.R.1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R.878 - Right to Try Act of 2017 S.204 - Trickett Wendler Right to Try Act of 2017 H.R.1854/ S. 778 - Prescription Drug Monitoring Act of 2017 Diagnostic Accuracy and Innovation Act (DAIA)(Draft legislation) H.R. 2430 FDA Reauthorization Act S. 934 FDA Reauthorization Act H.R. 2797/ S.1334Patient Choice and Quality Care Act (PCQCA) H.R. 2999Patient's Access to Treatment Act (PATA) H.R. 1628Better Care Reconciliation Act (BCRA) H.R. 1316Prescription Drug Pricing Transparency Act H.R. 2077 Restoring Patients Voices Act
Client expense: $223,857 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including: H.R.1676 & S.693, the Palliative Care and Hospice Education and Training Act; H.R. 4122 & S. 2006, the Breast Density & Mammography Reporting Act; H.R.820 & S.292, the Childhood Cancer STAR Act; and, H.R. 1231 & S. 456, the RACE for Children Act. In addition, issues related to reform of laboratory and diagnostic tests and the development of a new discussion draft for the Diagnostic Accuracy and Innovation Act; and H.R.772 and S.261, the Common Sense Nutrition Disclosure Act. Issues relating to anti-cancer medication cost-sharing parity respecting H.R. 1409. Issues regarding a national family caregiving strategy respecting S. 1719 and H.R. 1028. Issues regarding access to medicines respecting S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, as well as H.R.878, the Right to Try Act of 2017. Issues regarding lymphedema treatment respecting The Lymphedema Treatment Act, H.R. 930 and S. 497. The proposed Medical Records Fairness Act (no number yet). Issues regarding the Affordable Care Act premium tax credits and catastrophic plans, HR 6311. Issues regarding protections for people with pre-existing conditions, including S. 3388, HR 6898, and H. Res. 1066. Resolutions to disapprove the short-term rule, H.J. Res 140 and S. J. Res. 63. Advocacy against including the Association Health Plan provision of the House Farm bill in the conference report, H.R. 2 and s. 3042 (section 6004 of the House-passed version of the legislation). Issues involving patient navigation, including the Patient Navigation Assistance Act, HR 6808. H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, respecting Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, and protecting communities. Draft legislation on patient access to medical records. Draft legislation on FDA regulation of laboratory tests. H.R. 4897 & S. 2358 Women and Lung Cancer Research and Preventive Services Act of 2018. Issues related to caregiving, including H.R. 3759/S. 1028, the RAISE Family Caregivers Act.
Client expense: $1,230,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Client expense: $1,330,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2018 · third_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill, Raising Awareness of Cystic Fibrosis ***, no specific bill, appropriations for the Department of Health and Human Services, PDUFA, Sunshine, Orphan drugs, 340B, Innovation, EXPERT, Non-interference, drug development policies
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 no specific bills: Innovation, Duchenne Muscular Dystrophy, platform technologies, non-interference
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 878/S. 204 - Right to Try Act H.R. 1231/S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 849/S. 260 - Protecting Seniors' Access to Medicare Act S. 2852 - Pandemic and All Hazards Preparedness Act S.2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act H.R. 6 - SUPPORT for Patients and Communities Act ***no specific bills, importation, supply chain integrity, 304b, biosimilars, orphan drugs, newborn screening, expanded access, priority review, transparency, drug shortages, IPAB
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)
2018 · third_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 456 - RACE for Children Act S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act no specific bills, 340B, Innovation, Transparency, Precision Medicine, NIH, Importation, Non-Interference, Vaccines, Biosimilars, Compounding
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Cost Through Competition Act H.R. 1231/S. 456 - RACE for Children Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bills; user fee reauthorization, non-interference, dormant therapies, drug shortages, prescription drug access and affordability
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act S. 2852 - Pandemic and All Hazards Preparedness Act ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, Innovation, 340B, comparative effectiveness research, user fee reauthorization, non-interference, IPAB
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2018 · third_quarter · Health Issues
FDA - rare and orphan disease issues; Prescription drug coverage and payment policies; Medical innovation issues; H.R. 1231/S. 456 - Research to Accelerate Cures and Equity for Children Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Health Issues
FDA - rare and orphan disease issues; Prescription drug coverage and payment policies; Medical innovation issues; H.R. 1231/S. 456 - Research to Accelerate Cures and Equity for Children Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
FDA - rare and orphan disease issues; Prescription drug coverage and payment policies; Medical innovation issues; H.R. 1231/S. 456 - Research to Accelerate Cures and Equity for Children Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Client expense: $3,060,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2018 · second_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act S. 2852 - Pandemic and All Hazards Preparedness Act ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, Innovation, 340B, comparative effectiveness research, user fee reauthorization, non-interference, IPAB
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2018 · second_quarter · Health Issues
FDA - rare and orphan disease issues; Prescription drug coverage and payment policies; Medical innovation issues; H.R. 1231/S. 456 - Research to Accelerate Cures and Equity for Children Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
PL114-255 - 21st Century Cures, implementation H.R. 1231/S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 H.R. 1245/S. 469 - Affordable and Safe Prescription Drug Importation Act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 1827 - KIDS Act of 2017 S. 64/S. 92/H.R. 1480 - Safe and Affordable Drugs from Canada Act H.R. 1245 - Affordable and Safe Prescription Drug Importation Act H.Res. 40/S.Res. 451 - Endometriosis Awareness Month H.R. 1776 - Improving Access to Affordable Prescription Drugs Act no specific bill - FDA implementation issues, 340B, biosimilars, prescription drug user fee reauthorization, non-interference, patient assistance, importation, Puerto Rico
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 878/S. 204 - Right to Try Act H.R. 1231/S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 849/S. 260 - Protecting Seniors' Access to Medicare Act S. 2852 - Pandemic and All Hazards Preparedness Act S.2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act ***no specific bills, importation, supply chain integrity, 304b, biosimilars, orphan drugs, newborn screening, expanded access, priority review, transparency, drug shortages, IPAB
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)
2018 · second_quarter · Health Issues
H.R.1409 - Cancer Drug Parity Act of 2017 H.R.820/ S. 292 - Childhood Cancer STAR Act H.R.1231/S. 456 - RACE for Children Act H.R.1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R.878 - Right to Try Act of 2017 S.204 - Trickett Wendler Right to Try Act of 2017 H.R.1854/ S. 778 - Prescription Drug Monitoring Act of 2017 Diagnostic Accuracy and Innovation Act (DAIA)(Draft legislation) H.R. 2430 FDA Reauthorization Act S. 934 FDA Reauthorization Act H.R. 2797/ S.1334Patient Choice and Quality Care Act (PCQCA) H.R. 2999Patient's Access to Treatment Act (PATA) H.R. 1628Better Care Reconciliation Act (BCRA) H.R. 1316Prescription Drug Pricing Transparency Act H.R. 2077 Restoring Patients Voices Act
Client expense: $62,560 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Medical/Disease Research/Clinical Labs
Legislation and policies related to: Pediatric and childrens health research Nursing research Draft legislation to reauthorize and modernize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 2430/S. 934 - FDA Reauthorization Act of 2017 S. 292/H.R. 820 - Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act of 2017 S. 456/H.R. 1231 - Research to Accelerate Cures and Equity (RACE) for Children Act
Client expense: Not reported · Firm income: $23,450
Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing
Client expense: $860,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2018 · second_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill, Raising Awareness of Cystic Fibrosis ***, no specific bill, appropriations for the Department of Health and Human Services, PDUFA, Sunshine, Orphan drugs, 340B, Innovation, EXPERT, Non-interference, drug development policies
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · second_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 no specific bills: Innovation, Duchenne Muscular Dystrophy, platform technologies, non-interference
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 456 - RACE for Children Act S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act no specific bills, 340B, Innovation, Transparency, Precision Medicine, NIH, Importation, Non-Interference, Vaccines, Biosimilars, Compounding
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · second_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Cost Through Competition Act H.R. 1231/S. 456 - RACE for Children Act no specific bills; user fee reauthorization, non-interference, dormant therapies, drug shortages, prescription drug access and affordability
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
Issues relating to health disparities, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including: H.R.1676 & S.693, the Palliative Care and Hospice Education and Training Act; the Breast Density & Mammography Reporting Act; H.R.820 & S.292, Childhood Cancer STAR Act; and, H.R. 1231 & S. 456, the RACE for Children Act. In addition, the discussion draft of The Diagnostic Accuracy and Innovation Act; and H.R.772 and S.261, the Common Sense Nutrition Disclosure Act. Issues relating to anti-cancer medication cost-sharing parity respecting H.R. 1409. Issues regarding a national family caregiving strategy respecting S. 1719 and H.R. 1028. Issues regarding access to medicines respecting S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, as well as H.R.878, the Right to Try Act of 2017. Issues regarding lymphedema treatment respecting The Lymphedema Treatment Act, H.R. 930 and S. 497. Issues regarding access to care respecting the Bi-partisan Health Care Stabilization Act (Alexander-Murray) and S 1835, The Lower Premiums through Reinsurance Act. H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, respecting Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, and protecting communities. Draft legislation on patient access to medical records. Draft legislation on FDA regulation of laboratory tests.
Client expense: $900,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
2018 · first_quarter · Health Issues
Issues: Innovation, Duchenne muscular dystrophy, platform technologies PL 114-255 - 21st Century Cures implementation S.204 - Right to Try Act of 2017 S.771 - Improving Access To Affordable Prescription Drugs Act S.637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry from Keeping Drugs Expensive Act of 2017 S.469 - Affordable and Safe Prescription Drug Importation Act HR 749 - Lower Drug Costs Through Competition Act HR 1628 - American Health Care Act HR 2430 - FDA Reauthorization Act of 2017 S. 456 - RACE for Children Act HR 1625 - Consolidated Appropriations Act of 2018 HR 1892 - Bipartisan Budget Act of 2018
Client expense: $130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Health Issues
Issues relating to health disparities, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including: H.R.1676 & S.693, the Palliative Care and Hospice Education and Training Act; the Breast Density & Mammography Reporting Act; H.R.820 & S.292, Childhood Cancer STAR Act; and, H.R. 1231 & S. 456, the RACE for Children Act. In addition, the discussion draft of The Diagnostic Accuracy and Innovation Act; and H.R.772 and S.261, the Common Sense Nutrition Disclosure Act. Preservation of the Prevention and Public Health Fund and reauthorization of the CHIP program and FQHCs respecting H.R. 3922. Issues relating to anti-cancer medication cost-sharing parity respecting H.R. 1409. Issues regarding a national family caregiving strategy respecting S. 1719 and H.R. 1028. Issues regarding access to medicines respecting S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, as well as H.R.878, the Right to Try Act of 2017. Issues regarding lymphedema treatment respecting The Lymphedema Treatment Act, H.R. 930 and S. 497. Issues regarding access to care respecting the Bi-partisan Health Care Stabilization Act (Alexander-Murray) and S 1835, The Lower Premiums through Reinsurance Act.
Client expense: $650,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office
2018 · first_quarter · Health Issues
FDA - rare and orphan disease issues; Prescription drug coverage and payment policies; Medical innovation issues; H.R. 1231/S. 456 - Research to Accelerate Cures and Equity for Children Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Medical/Disease Research/Clinical Labs
Legislation and policies related to: Pediatric and childrens health research Nursing research Draft legislation to reauthorize and modernize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 2430/S. 934 - FDA Reauthorization Act of 2017 S. 292/H.R. 820 - Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act of 2017 S. 456/H.R. 1231 - Research to Accelerate Cures and Equity (RACE) for Children Act
Client expense: Not reported · Firm income: $23,450
Government targets: Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)
Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Biosimilar pass through payments Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments
Client expense: $3,280,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2018 · first_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 2430 - FDA Reauthorization Act of 2017 S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Cost Through Competition Act H.R. 1231/S. 456 - RACE for Children Act no specific bills; user fee reauthorization, non-interference, dormant therapies
Client expense: Not reported · Firm income: $80,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Health Issues
H.R.1628, American Health Care Act of 2017/Better Care Reconciliation Act of 2017; H.R.2051, FAST Generics Act of 2017. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. H.R.231/S.456, RACE for Children Act. TRICARE issues in the FY19 National Defense Authorization Act. S.2434, Animal Drug and Animal Generic Drug User Fee Amendments of 2018. P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA). 340B drug discount program; truthful non-misleading industry communications; compassionate use/right to try; importation of biopharmaceuticals; drug pricing; transparency; reauthorization of the Children's Health Insurance Program (CHIP); opioid funding.
Client expense: Not reported · Firm income: $50,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2018 · first_quarter · Health Issues
H.R.1409 - Cancer Drug Parity Act of 2017 H.R.820/ S. 292 - Childhood Cancer STAR Act H.R.1231/S. 456 - RACE for Children Act H.R.1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R.878 - Right to Try Act of 2017 S.204 - Trickett Wendler Right to Try Act of 2017 H.R.1854/ S. 778 - Prescription Drug Monitoring Act of 2017 Diagnostic Accuracy and Innovation Act (DAIA)(Draft legislation) H.R. 2430 FDA Reauthorization Act S. 934 FDA Reauthorization Act H.R. 2797/ S.1334Patient Choice and Quality Care Act (PCQCA) H.R. 2999Patient's Access to Treatment Act (PATA) H.R. 1628Better Care Reconciliation Act (BCRA) H.R. 1316Prescription Drug Pricing Transparency Act H.R. 2077 Restoring Patients Voices Act
Client expense: $37,103 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill, Raising Awareness of Cystic Fibrosis ***, no specific bill, appropriations for the Department of Health and Human Services, PDUFA, Sunshine, Orphan drugs, 340B, Innovation, EXPERT, Non-interference, drug development policies
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · first_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 456 - RACE for Children Act S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act H.R. 2430 - FDA Reauthorization Act of 2017 no specific bills, 340B, Innovation, Transparency, Precision Medicine, NIH, Importation, Non-Interference, Vaccines, Biosimilars, Compounding
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · first_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 no specific bills: Innovation, Duchenne Muscular Dystrophy, platform technologies, non-interference
Client expense: Not reported · Firm income: $80,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Health Issues
PL114-255 - 21st Century Cures, implementation H.R. 1231/S. 456 - RACE for Children Act H.R 1628 - American Health Care Act of 2017 S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 1827 - KIDS Act of 2017 S. 64/S. 92/H.R. 1480 - Safe and Affordable Drugs from Canada Act H.R. 1245 - Affordable and Safe Prescription Drug Importation Act H.Res. 403 - Endometriosis Awareness Month no specific bill - FDA implementation issues, 340B, biosimilars, prescription drug user fee reauthorization, non-interference, patient assistance, importation, Puerto Rico
Client expense: Not reported · Firm income: $60,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Health Issues
PL 114-255 - 21st Century Cures, implementation H.R. 878/S. 204 - Right to Try Act H.R. 1231/S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 849/S. 260 - Protecting Seniors' Access to Medicare Act ***no specific bills, importation, supply chain integrity, 304b, biosimilars, orphan drugs, newborn screening, expanded access, priority review, transparency, drug shortages, IPAB
Client expense: Not reported · Firm income: $70,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE