RACE for Children Act

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)

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

Health Care Reform Legislation HR1628 Access to Affordable Prescription Drugs Medicare Prescription Drug Price Negotiation Act HR 242 Protecting Medicare from executive Action S 251 Medicare Prescription Drug Price Negotiation Act S 41 Race for Children Act HR 1231

Client expense: Not reported · Firm income: $20,000

Government targets: Administration for Children & Families (ACF), HOUSE OF REPRESENTATIVES, SENATE

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)

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

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

General education about policies impacting pharmaceutical development, approval and reimbursement; Non-interference. Rebates for Medicare Part D. Importation. 340B Drug Pricing Program. CMMI Medicare Part B Demonstration; Right to Try; H.R. 1231, RACE for Children Act. Independent Payment Advisory Board. Legislation to address opioid addiction and treatment, including H.R. 6 Support for Patients and Communities Act.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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)

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

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

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

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

Health Care Reform Legislation HR1628 Access to Affordable Prescription Drugs Medicare Prescription Drug Price Negotiation Act HR 242 Protecting Medicare from executive Action S 251 Medicare Prescription Drug Price Negotiation Act S 41 Race for Children Act HR 1231

Client expense: Not reported · Firm income: $20,000

Government targets: Administration for Children & Families (ACF), HOUSE OF REPRESENTATIVES, SENATE

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

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

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)

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

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)

General education about policies impacting pharmaceutical development, approval and reimbursement; Non-interference. Rebates for Medicare Part D. Importation. 340B Drug Pricing Program. CMMI Medicare Part B Demonstration; Right to Try; H.R. 1231, RACE for Children Act. Independent Payment Advisory Board. H.R. 1625, Consolidated Appropriations Act of FY 2019. Legislation to address opioid addiction and treatment, including H.R. 6 SUPPORT for Patients and Communities Act.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Health Care Reform Legislation HR1628 Access to Affordable Prescription Drugs Medicare Prescription Drug Price Negotiation Act HR 242 Protecting Medicare from executive Action S 251 Medicare Prescription Drug Price Negotiation Act S 41 Race for Children Act HR 1231

Client expense: Not reported · Firm income: $20,000

Government targets: Administration for Children & Families (ACF), HOUSE OF REPRESENTATIVES, SENATE

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

General education about policies impacting pharmaceutical development, approval and reimbursement; Non-interference. Rebates for Medicare Part D. Importation. 340B Drug Pricing Program. CMMI Medicare Part B Demonstration; H.R. 1628, American Health Care Act of 2017; Right to Try; H.R. 1231, RACE for Children Act. Independent Payment Advisory Board. H.R. 1625, Consolidated Appropriations Act of FY 2019.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

S. 297: Increasing Competition in Pharmaceuticals Act S. 469: Affordable and Safe Prescription Drug Importation Act S. 771: Improving Access to Affordable Prescription Drugs Act H.R. 749: Lower Drug Costs Through Competition Act H.R. 1231: RACE for Children Act H.R. 1245: Affordable and Safe Prescription Drug Importation Act H.R. 1776: Improving Access to Affordable Prescription Drugs Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program H.R. 4710: 340B Preserving Patient Access for the Underserved and Safety-Net Entities Act or PAUSE Act - Provisions related to the 340B program 340B drug discount program policy issues H.R. 749: Lower Drug Costs Through Competition Act S. 469: Affordable and Safe Prescription Drug Importation Act H.Res. 403: Supporting the designation of March 2018 as Endometriosis Awareness Month S.Res.451: A resolution recognizing the significance of endometriosis as an unmet chronic disease for women and designating March 2018 as "Endometriosis Awareness Month"

Client expense: $2,890,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to drug rescheduling H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication-assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R.4297 - Protecting Seniors Through Immunization Act HR4993, Vaccine Access Improvement Act, Technical fix to efficiently add new vaccines to VICPHR4297/S2103, Protecting Seniors through Immunization Act, HR 1625 - Consolidated Appropriatons Act of 2018 - Part D Doughnut HoleHR 1625 - Consolidated Approriations Act of 2018 - Ryan White and ADAP FundingHR 1892 - Further Extension of Continuing Appropriations Act, 2018 - Part D Doughnut Hole HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform ActHR 4710 - 340B PAUSE ActS 2312 - HELP Act340B Drug Discount ProgramMedicare Part D - Doughnut Hole; Non-Interference ClauseFY19 Appropriations - DoD - Oral HealthFY19 Appropriations - HHS - Ryan White Program/ADAPHR 394 - Restoring Access to Medication ActS 85 - Restoring Access to Medication Act of 2017HR 4618 - To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication. Medicaid - access for chronic care patients Prescription Drug PricingS469 - Affordable and Safe Prescription Drug Importation Act HR 1245 - Affordable and Safe Prescription Drug Importation Act Drug Importation HR 242 - Medicare Prescription Drug Price Negotiation Act of 2017Draft legislation on opioids - FDA packaging and disposal Draft legislation on opioids - Tableting and Encapsulating Machine Regulation Act of 2018 H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. __: FDA and International Mail - Provisions related to chemical importation H.R. __: FDA Long-term Efficacy - Provisions related to post-approval studies H.R. __: FDA Misuse/Abuse - Provisions related to misuse/abuse in approval decisions H.R. __: FDA Packaging and Disposal - Provisions related to drug packaging H.R. __: Tableting and Encapsulating Machine Regulation Act of 2018 - Provisions related to manufacturing equipment H.R. __: The Special Registration for Telemedicine Clarification Act of 2018 - Provisions related to telemedicine H.R. __: The Improving Access to Remote Behavioral Health Treatment Act of 2018 - Provisions related to telemedicine H.R. __: A Bill to Improve Fentanyl Testing and Surveillance - Provisions related to synthetic opioid detection grants H.R. __: A Bill to Enhance and Improve State-run Prescription Drug Monitoring Programs - Provisions related to evidence-based overdose prevention grants and other funding H.R. __: A Bill to Support the Peer Support Specialist Workforce - Provisions related to national youth recovery grants and other funding H.R. __: FDA Accelerated Approval and Breakthrough Therapy Status - Provisions related to expedited treatment for non-opioid medicines H.R. __: FDA Opioid Sparing - Provisions related to alternative models for data collection S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2456: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. __: Access to Increased Drug Disposal Act of 2018 - Provisions related to grants for disposal Biopharmaceutical innovation policy issues Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues National All Schedules Prescription Electronic Reporting Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Clinical trial policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Confirmation of Alex Azar Opioids shortages policy issues

Client expense: $1,110,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Administration, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

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)

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

H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to drug rescheduling H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication-assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. __: FDA and International Mail - Provisions related to chemical importation H.R. __: FDA Long-term Efficacy - Provisions related to post-approval studies H.R. __: FDA Misuse/Abuse - Provisions related to misuse/abuse in approval decisions H.R. __: FDA Packaging and Disposal - Provisions related to drug packaging H.R. __: Tableting and Encapsulating Machine Regulation Act of 2018 - Provisions related to manufacturing equipment H.R. __: The Special Registration for Telemedicine Clarification Act of 2018 - Provisions related to telemedicine H.R. __: The Improving Access to Remote Behavioral Health Treatment Act of 2018 - Provisions related to telemedicine H.R. __: A Bill to Improve Fentanyl Testing and Surveillance - Provisions related to synthetic opioid detection grants H.R. __: A Bill to Enhance and Improve State-run Prescription Drug Monitoring Programs - Provisions related to evidence-based overdose prevention grants and other funding H.R. __: A Bill to Support the Peer Support Specialist Workforce - Provisions related to national youth recovery grants and other funding H.R. __: FDA Accelerated Approval and Breakthrough Therapy Status - Provisions related to expedited treatment for non-opioid medicines H.R. __: FDA Opioid Sparing - Provisions related to alternative models for data collection S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2456: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. __: Access to Increased Drug Disposal Act of 2018 - Provisions related to grants for disposal Biopharmaceutical innovation policy issues Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues National All Schedules Prescription Electronic Reporting Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Clinical trial policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Confirmation of Alex Azar Opioids shortages policy issues

Client expense: $9,960,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Administration, Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE

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

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

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

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: $1,840,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

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: $1,840,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 204: Trickett Wendler Right to Try Act of 2017 S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act H.R. 749: Lower Drug Costs Through Competition Act - Provisions related to generic drug approvals and priority review vouchers H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1231: RACE for Children Act - Provisions related to pediatric studies S. 456: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 H.R. 1776: Improving Access to Affordable Prescription Drugs Act Prescription Drug User Fee Act (PDUFA) reauthorization Biologics User Fee Act (BsUFA) reauthorization 340B drug discount program policy issues Orphan Drug Act policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues H.R. 2430: FDA Reauthorization Act of 2017 - Provisions related to user fee programs PL 114-255-21st Century Cures, implementation H.R. 749-Lower Drug Costs Through Competition Act Better Care Reconciliation Act of 2017 Graham-Cassidy Amendment H.R.2430/S.934: FDA Reauthorization Act of 2017

Client expense: $1,230,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE, Treasury, Dept of

Regulatory and legislative health care issues impacting pricing and access in the following legislation: H.R. 1628 - American Health Care Act (AHCA) - To provide for reconciliation pursuant to title II of the concurrent resolution on the budget for fiscal year 2017 S. ____ - Better Care Reconciliation Act (BCRA) - To provide for reconciliation pursuant to title II of the concurrent resolution on the budget for fiscal year 2017. S. 204/H.R. 878 - Trickett Wendler Right To Try Act of 2017 S. 456/H.R. 1231 - Research to Accelerate Cures and Equity (RACE) for Children Act S. 870 - Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 Regulatory and legislative health care issues, including the 340B program Issues related to the treatment of obesity Drug Cost and Pricing

Client expense: $460,000 · Firm income: Not reported

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE

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; Orphan Drug tax provisions in H.R. 1.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

ADHD Awareness *Drug Values -Binge Eating Disorder awareness -DEA processes and re-exportation -FDA Funding -Medicaid rare disease patient access to therapy Patient access to therapy, including Medicaid, Medicare, and insurance. -Orphan Drug Act regulations -HR 1628 - American Health Care Act of 2017 American Health Care Act of 2017/Better Care Reconciliation Act (H.R. 1628), including patient access, needs for rare disease patients, coverage issues, pre-existing conditions, lifetime and annual caps, essential health benefits, Medicaid, reimbursement, and insurance. -PDUFA Reauthorization The Food and Drug Act Reauthorization Act (FDARA) of 2017 (H.R. 2430 and S. 934), including the PDUFA Reauthorization, RACE for Children Act, Right-to-Try, expanded access, clinical superiority standards, drug access and values, off-label communications, pediatric labeling and generic drugs, and drug importation. -Expanded Access -NIH funding, including expansion for rare diseases -Rare Disease awareness -RACE for Children Act (S. 456 and H.R. 1231) -Right to Try legislation (S. 204, H.R. 878, and H.R. 2368) -Pharmaceutical Information Exchange Act (H.R. 2026) -Drug Diversion and Counterfeit Crackdown Act of 2017 (H.R. 2376) -Medical Product Communications Act (H.R. 1703) -Newborn Screening -Study eligibilities for DOD PRMRP

Client expense: $550,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Regulatory and legislative health care issues impacting pricing and access in the following legislation: S. ____ - Better Care Reconciliation Act (BCRA) - To provide for reconciliation pursuant to title II of the concurrent resolution on the budget for fiscal year 2017. S. 204/H.R. 878 - Trickett Wendler Right To Try Act of 2017 S. 456/H.R. 1231 - Research to Accelerate Cures and Equity (RACE) for Children Act S. 870 - Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 Regulatory and legislative health care issues, including the 340B program Issues related to the treatment of obesity Drug Cost and Pricing

Client expense: $353,000 · Firm income: Not reported

Government targets: Congressional Budget Office (CBO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE

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; Orphan Drug tax provisions in H.R. 1.

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 892: Opioid Addiction Prevention Act of 2017 - Scheduling issues S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing H.R. 1: Tax Cuts and Jobs Act - An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (Public Law 115-97) H.R. 749: Lower Drug Costs Through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Scheduling issues H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 4710: 340B Protecting Access for the Underserved and Safety-Net Entities Act or PAUSE Act - 340B program Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Cancer drug vial size policy issues A Better Deal economic platform proposal - Provisions related to drug cost and pricing policy issues TRICARE pharmacy pilot program Confirmation of Alex Azar HR 4710 - 340B PAUSE ActHR 4297 - Protecting Seniors Through Immunization Act of 2017H.J.Res. 123 - Making further continuing appropriations for fiscal year 2018, and for other purposes.Graham-Cassidy Health Care Bill (S. Amdt. 1030 to HR 1628, the American Health Care Act of 2017)HR 4297/S. 2103 - Protecting Seniors Through Immunization Act of 2017Monograph Reform House and Senate Continuing Resolution IPAB Legislation-House 340B Tax Reform

Client expense: $1,110,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 892: Opioid Addiction Prevention Act of 2017 - Scheduling issues S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing H.R. 1: Tax Cuts and Jobs Act - An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (Public Law 115-97) H.R. 749: Lower Drug Costs Through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Scheduling issues H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 4710: 340B Protecting Access for the Underserved and Safety-Net Entities Act or PAUSE Act - 340B program Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Ensuring Patient Access and Effective Drug Enforcement Act of 2016 (Public Law No. 114-145) Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Cancer drug vial size policy issues A Better Deal economic platform proposal - Provisions related to drug cost and pricing policy issues Confirmation of Alex Azar TRICARE pharmacy pilot program

Client expense: $5,880,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE

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

Client expense: $121,530 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE