Promising Pathway Act

H.R. 1305: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2023; ALL PROVISIONS H.R. 2940: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS H.R. 4408: PROMISING PATHWAY ACT; ALL PROVISIONS H.R. 7436: ANTIMICROBIAL RESISTANCE RESEARCH ASSESSMENT ACT OF 2024; ALL PROVISIONS S. 1355: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS S. 1906: PROMISING PATHWAY ACT; ALL PROVISIONS S. 4426: PROMISING PATHWAY ACT 2.0; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING THE 2025 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, PUBLIC HEALTH WORKFORCE REPAYMENT PROGRAM, BIO-PREPAREDNESS WORKFORCE PILOT PROGRAM AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

Client expense: $300,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

H.R. 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 1305: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2023; ALL PROVISIONS H.R. 2940: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS H.R. 4408: PROMISING PATHWAY ACT; ALL PROVISIONS H.R. 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS H.R. 7383: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT; ALL PROVISIONS H.R. 7436: ANTIMICROBIAL RESISTANCE RESEARCH ASSESSMENT ACT OF 2024; ALL PROVISIONS H.R. 7623: TELEHEALTH MODERNIZATION ACT OF 2024; ALL PROVISIONS H.R. 7829: SUPPLEMENTAL OXYGEN ACCESS REFORM (SOAR) ACT OF 2024; ALL PROVISIONS H.R. 8467: FARM, FOOD, AND NATIONAL SECURITY ACT OF 2024; PROVISIONS RELATING TO SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM (SNAP) AND THE THRIFTY FOOD PLAN S. 1214: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT: ALL PROVISIONS S. 1355: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS S. 1375: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS S. 1906: PROMISING PATHWAY ACT; ALL PROVISIONS S. 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS S. 2973: MODERNIZING AND ENSURING PBM ACCOUNTABILITY ACT; ALL PROVISIONS S. 4426: PROMISING PATHWAY ACT 2.0; ALL PROVISIONS (DRAFT) IMPROVING SENIORS' TIMELY ACCESS TO CARE ACT; ALL PROVISIONS (DRAFT) MEDICAL RECORDS ACCESS FAIRNESS ACT; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING THE ADVANCE PAYMENTS OF THE PREMIUM TAX CREDIT (APTC) UNDER THE AFFORDABLE CARE ACT AND RELATED ISSUES GENERAL DISCUSSIONS REGARDING DRAFT BILL ON TAX CREDITS FOR AMR DEVELOPMENT GENERAL DISCUSSIONS REGARDING THE 2025 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, PUBLIC HEALTH WORKFORCE REPAYMENT PROGRAM, BIO-PREPAREDNESS WORKFORCE PILOT PROGRAM AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

Promising Pathways Act (H.R. 4408/S. 1906) - Discussion around a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS and coverage for these drugs. BENEFIT Act of 2023 (H.R.1092/S.526) - Provisions related to increases in patient and advocate role in FDA benefit-risk framework for drug approval through leveraging patient experience, PFDD, and related data.

Client expense: $25,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1305: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2023; ALL PROVISIONS H.R. 2940: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS H.R. 4408: PROMISING PATHWAY ACT; ALL PROVISIONS H.R. 7436: ANTIMICROBIAL RESISTANCE RESEARCH ASSESSMENT ACT OF 2024; ALL PROVISIONS S. 1355: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS S. 1906: PROMISING PATHWAY ACT; ALL PROVISIONS S. 4426: PROMISING PATHWAY ACT 2.0; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING THE 2025 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, PUBLIC HEALTH WORKFORCE REPAYMENT PROGRAM, BIO-PREPAREDNESS WORKFORCE PILOT PROGRAM AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

Client expense: $380,000 · Firm income: Not reported

H.R. 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 1305: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2023; ALL PROVISIONS H.R. 2940: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS H.R. 4408: PROMISING PATHWAY ACT; ALL PROVISIONS H.R. 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS H.R. 7383: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT; ALL PROVISIONS H.R. 7436: ANTIMICROBIAL RESISTANCE RESEARCH ASSESSMENT ACT OF 2024; ALL PROVISIONS H.R. 7623: TELEHEALTH MODERNIZATION ACT OF 2024; ALL PROVISIONS H.R. 7829: SUPPLEMENTAL OXYGEN ACCESS REFORM (SOAR) ACT OF 2024; ALL PROVISIONS H.R. 8467: FARM, FOOD, AND NATIONAL SECURITY ACT OF 2024; PROVISIONS RELATING TO SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM (SNAP) AND THE THRIFTY FOOD PLAN S. 1214: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT: ALL PROVISIONS S. 1355: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS S. 1375: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS S. 1906: PROMISING PATHWAY ACT; ALL PROVISIONS S. 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS S. 2973: MODERNIZING AND ENSURING PBM ACCOUNTABILITY ACT; ALL PROVISIONS S. 4426: PROMISING PATHWAY ACT 2.0; ALL PROVISIONS (DRAFT) IMPROVING SENIORS' TIMELY ACCESS TO CARE ACT; ALL PROVISIONS (DRAFT) MEDICAL RECORDS ACCESS FAIRNESS ACT; ALL PROVISIONS GENERAL DISCUSSIONS REGARDING THE ADVANCE PAYMENTS OF THE PREMIUM TAX CREDIT (APTC) UNDER THE AFFORDABLE CARE ACT AND RELATED ISSUES GENERAL DISCUSSIONS REGARDING DRAFT BILL ON TAX CREDITS FOR AMR DEVELOPMENT GENERAL DISCUSSIONS REGARDING THE 2025 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, PUBLIC HEALTH WORKFORCE REPAYMENT PROGRAM, BIO-PREPAREDNESS WORKFORCE PILOT PROGRAM AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

Policies related to drug approval for treatment of rare diseases. Policies related to exclusivity of small molecule drugs. H.R. 4408/S. 1906, Promising Pathway Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 830/S. 1375, HELP Copays Act H.R. 2630/S. 652, Safe Step Act H.R. 2673, American Innovation and R&D Competitiveness Act of 2023 H.R.5539/S.3131, ORPHAN Cures Act H.R.7384, the Creating Hope Reauthorization Act of 2024 H.R.4408/S.1906, Promising Pathway Act

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES

Rare Disease Initiatives. Telehealth. Priority Review Voucher Reauthorization. H.R.4408/S.1906: Promising Pathway Act (PPA).

Client expense: $70,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Natl Institutes of Health (NIH), SENATE

Pharmaceutical issues impacting patients with rare diseases. Orphan Drug Act. H.R.7383/S.1214: RARE Act. Inflation Reduction Act Implementation. H.R.4408/S.1906: Promising Pathway Act (PPA). Lab-developed tests (LDTs) and genetic testing access. PRV Reauthorization.

Client expense: $70,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Promising Pathways Act (H.R. 4408/S. 1906) - Discussion around a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS and coverage for these drugs. BENEFIT Act of 2023 (H.R.1092/S.526) - Provisions related to increases in patient and advocate role in FDA benefit-risk framework for drug approval through leveraging patient experience, PFDD, and related data.

Client expense: $25,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1305: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2023; ALL PROVISIONS H.R. 2940: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS H.R. 4408: PROMISING PATHWAY ACT; ALL PROVISIONS H.R. 7436: ANTIMICROBIAL RESISTANCE RESEARCH ASSESSMENT ACT OF 2024; ALL PROVISIONS S. 1355: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS S. 1906: PROMISING PATHWAY ACT; ALL PROVISIONS S. 2333: PANDEMIC AND ALL HAZARDS PREPAREDNESS AND RESPONSE ACT; PROVISIONS RELATING TO PUBLIC HEALTH EMERGENCY PREPAREDNESS AND COMBATING ANTIMICROBIAL RESISTANCE (DRAFT) PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING THE 2024 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION GENERAL DISCUSSIONS REGARDING THE 2025 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

Client expense: $430,000 · Firm income: Not reported

H.R. 824: TELEHEALTH BENEFIT EXPANSION FOR WORKERS ACT OF 2023; ALL PROVISIONS H.R. 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 1305: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2023; ALL PROVISIONS H.R. 2940: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS H.R. 4408: PROMISING PATHWAY ACT; ALL PROVISIONS H.R. 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS H.R. 5434: STABILIZE MEDICAID AND CHIP COVERAGE ACT; ALL PROVISIONS H.R. 7436: ANTIMICROBIAL RESISTANCE RESEARCH ASSESSMENT ACT OF 2024; ALL PROVISIONS S. 1214: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT: ALL PROVISIONS S. 1269: IMPROVING NEEDED SAFEGUARDS FOR USERS OF LIFESAVING INSULIN NOW (INSULIN) ACT OF 2023; ALL PROVISIONS S. 1355: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS S. 1375: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS S. 1906: PROMISING PATHWAY ACT; ALL PROVISIONS S. 2333: PANDEMIC AND ALL HAZARDS PREPAREDNESS AND RESPONSE ACT; PROVISIONS RELATING TO PUBLIC HEALTH EMERGENCY PREPAREDNESS AND COMBATING ANTIMICROBIAL RESISTANCE S. 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS S. 2973: MODERNIZING AND ENSURING PBM ACCOUNTABILITY ACT; ALL PROVISIONS S. 3138: STABILIZE MEDICAID AND CHIP COVERAGE ACT; ALL PROVISIONS (DRAFT) PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING THE 2024 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION GENERAL DISCUSSIONS REGARDING THE 2025 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Innovation in Pediatric Drugs Act of 2023 (H.R. 6664); S.2305 - Biosimilar Red Tape Elimination Act; Promising Pathway Act (S. 1906/H.R.4408); Give Kids a Chance Act of 2023 (H.R. 3433/S.2897); Affordable Prescriptions for Patients Act of 2023 (S. 150); Induced infringement and generic drug labeling; S.3583 - A bill to address patent thickets; REMEDY Act (S. 1209); Biosecure Act (S. 3558); proposed changes to Vaccine Injury Compensation Program.

Client expense: Not reported · Firm income: $190,000

Policies related to drug approval for treatment of rare diseases. Policies related to exclusivity of small molecule drugs. H.R. 4408/S. 1906, Promising Pathway Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 2369: VALID ACT OF 2023; ALL PROVISIONS OF THE BILL HR 2666: MEDICAID VBPS FOR PATIENTS ACT (MVP ACT); PROVISIONS RELATED TO OUTCOME BASED ARRANGEMENTS (OBA) AND VALUE BASED ARRANGEMENTS (VBA) HR 4408: PROMISING PATHWAY ACT; ALL PROVISIONS OF THE BILL S 1906: PROMISING PATHWAY ACT; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING 340B DRUG PRICING PROGRAM REFORM, RARE DISEASE GENE THERAPY ACCESS, CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS) PROPOSED PRICE JUSTIFICATION SURVEY, HEMOPHILIA GENE THERAPY, RARE DISEASE DRUG DEVELOPMENT

Client expense: $470,000 · Firm income: Not reported

Government targets: Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

S. 1906/H.R. 4408, Promising Pathway Act H.R.5894/S.2624, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, FY2024

Client expense: $80,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1305: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2023; ALL PROVISIONS H.R. 2940: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS H.R. 4408: PROMISING PATHWAY ACT; ALL PROVISIONS S. 1355: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS S. 1906: PROMISING PATHWAY ACT; ALL PROVISIONS S. 2333: PANDEMIC AND ALL HAZARDS PREPAREDNESS AND RESPONSE ACT; PROVISIONS RELATING TO PUBLIC HEALTH EMERGENCY PREPAREDNESS AND COMBATING ANTIMICROBIAL RESISTANCE (DRAFT) PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING THE 2024 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

Client expense: $90,000 · Firm income: Not reported

H.R. 824: TELEHEALTH BENEFIT EXPANSION FOR WORKERS ACT OF 2023; ALL PROVISIONS H.R. 830: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS H.R. 1305: SAVING US FROM PANDEMIC ERA RESISTANCE BY BUILDING A UNIFIED GLOBAL STRATEGY (SUPER BUGS) ACT OF 2023; ALL PROVISIONS H.R. 2940: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS H.R. 4408: PROMISING PATHWAY ACT; ALL PROVISIONS H.R. 4758: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS S. 1214: RETAINING ACCESS AND RESTORING EXCLUSIVITY (RARE) ACT: ALL PROVISIONS S. 1269: IMPROVING NEEDED SAFEGUARDS FOR USERS OF LIFESAVING INSULIN NOW (INSULIN) ACT OF 2023; ALL PROVISIONS S. 1355: THE PIONEERING ANTIMICROBIAL SUBSCRIPTIONS TO END UP SURGING RESISTANCE (PASTEUR) ACT OF 2023; ALL PROVISIONS S. 1375: HELP ENSURE LOWER PATIENT (HELP) COPAYS ACT; ALL PROVISIONS S. 1906: PROMISING PATHWAY ACT; ALL PROVISIONS S. 2333: PANDEMIC AND ALL HAZARDS PREPAREDNESS AND RESPONSE ACT; PROVISIONS RELATING TO PUBLIC HEALTH EMERGENCY PREPAREDNESS AND COMBATING ANTIMICROBIAL RESISTANCE S. 2372: ACCELERATING KIDS' ACCESS TO CARE ACT; ALL PROVISIONS S. 2973: MODERNIZING AND ENSURING PBM ACCOUNTABILITY ACT; ALL PROVISIONS (DRAFT) PREPARE FOR AND RESPOND TO EXISTING VIRUSES, EMERGING NEW THREATS, AND (PREVENT) PANDEMICS ACT; PROVISIONS REGARDING MEDICAL SUPPLY CHAIN, HEALTH DISPARITIES, PUBLIC HEALTH PREPAREDNESS AND RESPONSE CAPABILITIES GENERAL DISCUSSIONS REGARDING THE 2024 FISCAL YEAR APPROPRIATIONS; PROVISIONS RELATING TO FUNDING FOR DOMESTIC AND GLOBAL AMR PROGRAMS, AND PROTECTION OF MEDICARE, MEDICAID, AND SOCIAL SECURITY PROGRAMS, HEALTH AND HUMAN SERVICES AND RELATED AGENCIES, FOOD AND DRUG ADMINISTRATION AND RELATED AGENCIES, CENTER FOR DISEASE CONTROL AND PREVENTION AND RELATED AGENCIES, FUNDING FOR NUTRITION ASSISTANCE PROGRAMS, AND MEDICAL EXPENSE DEDUCTION

Policies related to drug approval for treatment of rare diseases. Policies related to exclusivity of small molecule drugs. H.R. 4408/S. 1906, Promising Pathway Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.1906/H.R.4408 Promising Pathway Act H.R.5007/S.2657 GREEN Hospitals Act

Client expense: $40,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Give Kids a Chance Act of 2023 (H.R. 3433); Affordable Prescriptions for Patients Act of 2023 (S. 150); Implementation and proposed amendments to the Inflation Reduction Act (P.L. 117-169); Promising Pathway Act (S. 1906/H.R.4408); Improving Efficiency to Increase Competition Act (H.R. 6684); Use code issues; Opioids regulation; Induced infringement and generic drug labeling; proposed amendments to the National Childhood Vaccine Injury Act and the Public Readiness and Emergency Preparedness (PREP) Act relating to compensation for injuries associated with covered vaccines.

Client expense: Not reported · Firm income: $180,000

H.R.4408/S.1906, Promising Pathway Act FDA Reform H.R. 2471 - Consolidated Appropriations Act, 2022 Rare Disease Drug Development

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Promising Pathways Act (H.R. 4408/S. 1906) - Discussion around a provisional approval path for drugs and biological interventions that meet unmet needs of rare diseases like ALS and coverage for these drugs. BENEFIT Act of 2023 (H.R.1092/S.526) - Provisions related to increases in patient and advocate role in FDA benefit-risk framework for drug approval through leveraging patient experience, PFDD, and related data.

Client expense: $25,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

ORPHAN Cures Act H.R. 5539; S. 3131 Promising Pathways Act HR 4408; S. 1906 PAHPA H.R.469 PAHPA S.R. 2333 Innovation in Pediatric Drugs Act of 2023

Client expense: $120,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE