Closing Loopholes for Orphan Drugs Act

HR 853- Closing Loopholes for Orphan Drug Act S. 368 - Telehealth Modernization Act S.4009 - Rural Hospital Support Act

Client expense: $15,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The 340B Drug Pricing Program; H.R.4390 - PROTECT 340B Act of 2021; Labor HHS Appropriations FY 2023; HR853 Closing Loopholes for Orphan Drugs Act; S. 2837, the 340B Accountability Act of 2021

Client expense: $298,834 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health Resources & Services Administration (HRSA), SENATE

340B Drug Pricing Program; Issues related to 340B contract pharmacies; Financial support for providers for diagnosis and treatment related to COVID-19, including funding for the Provider Relief Fund; coverage of COVID-19 related conditions; S. 168/H.R. 708 - Temporary; Reciprocity to Ensure Access to Treatment (TREAT) Act; S. 346/H.R. 959 - Black Maternal Health Momnibus Act; S. 773/H.R. 3203 - Legislation related to 340B eligibility; S. 368/H.R. 1332 - Telehealth Modernization Act; S. 1512/H.R. 2903 - CONNECT for Health Act; S. 1988 -Protecting Rural Telehealth Access Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; S.773/H.R. 3203 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program; - S.773/H.R. 3203; H.R. 5376 - Build Back Better Act; H.R. 853 - Closing Loopholes for Orphan Drugs Act; H.R. 2471 - Consolidated Appropriations Act (FY 2022 Omnibus); H.R. 7007 - Covid-19 Supplemental Appropriations Act

Client expense: $250,000 · Firm income: Not reported

HR 5931 - Inpatient Opioid Safety Act HR 853- Closing Loopholes for Orphan Drug Act S. 368 - Telehealth Modernization Act HR 3441- Substance Use Disorder Workforce Act S. 1438 - Opioid Workforce Act

Client expense: $15,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Amendments to Section 340B of the Public Health Service Act regarding eligibility for rural referral centers and sole community hospitals in the federal discount drug purchasing program, including the Closing Loopholes for Orphan Drugs Act (H.R. 853).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Pricing Program; Issues related to 340B contract pharmacies; Financial support for providers for diagnosis and treatment related to COVID-19, including funding for the Provider Relief Fund; coverage of COVID-19 related conditions; S. 168/H.R. 708 - Temporary; Reciprocity to Ensure Access to Treatment (TREAT) Act; S. 346/H.R. 959 - Black Maternal Health Momnibus Act; S. 773/H.R. 3203 - Legislation related to 340B eligibility; S. 368/H.R. 1332 - Telehealth Modernization Act; S. 1512/H.R. 2903 - CONNECT for Health Act; S. 1988 -Protecting Rural Telehealth Access Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; S.773/H.R. 3203 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program; - S.773/H.R. 3203;H.R. 5376 - Build Back Better Act; H.R. 853 - Closing Loopholes for Orphan Drugs Act; H.R. 2471 - Consolidated Appropriations Act (FY 2022 Omnibus); H.R. 7007 - Covid-19 Supplemental Appropriations Act

Client expense: $360,000 · Firm income: Not reported

HR 5931 - Inpatient Opioid Safety Act HR 853- Closing Loopholes for Orphan Drug Act S. 368 - Telehealth Modernization Act HR 3441- Substance Use Disorder Workforce Act S. 1438 - Opioid Workforce Act

Client expense: $15,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Amendments to Section 340B of the Public Health Service Act regarding eligibility for rural referral centers and sole community hospitals in the federal discount drug purchasing program, including the Closing Loopholes for Orphan Drugs Act (H.R. 853).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Pricing Program; Issues related to 340B contract pharmacies; Financial support for providers for diagnosis and treatment related to COVID-19; coverage of COVID-19 related conditions; S. 168/H.R. 708 - Temporary; Reciprocity to Ensure Access to Treatment (TREAT) Act; S. 346/H.R. 959 - Black Maternal Health Momnibus Act; S. 773/H.R. 3203 - Legislation related to 340B eligibility; S. 368/H.R. 1332 - Telehealth Modernization Act; S. 1512/H.R. 2903 - CONNECT for Health Act; S. 1988 -Protecting Rural Telehealth Access Act; H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; S.773/H.R. 3203 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program; - S.773/H.R. 3203; S.Con. Res 14 - Budget Resolution for FY2022 and issues related to the Build Back Better proposal; H.R. 853 - Closing Loopholes for Orphan Drugs Act

Client expense: $260,000 · Firm income: Not reported

HR 2144 - genetic counselors coverage under part B HR 853- Closing Loopholes for Orphan Drug Act S. 368 - Telehealth Modernization Act HR 3441- Substance Use Disorder Workforce Act S. 1438 - Opioid Workforce Act

Client expense: $15,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

The 340B Drug Pricing Program; S.773 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes; H.R.3203 - To enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes; H.R. 853: Closing Loopholes for Orphan Drugs Act; H.R. 4390: PROTECT 340B Act of 2021; S. 2837: 340B Accountability Act of 2021; S. 2814: Vital Medication Affordability Act; H.R. 5463: Drug Pricing Transparency and Accountability Act; H.R. 5376: Build Back Better Act

Client expense: $266,646 · Firm income: Not reported

Amendments to Section 340B of the Public Health Service Act regarding eligibility for rural referral centers and sole community hospitals in the federal discount drug purchasing program, including the Closing Loopholes for Orphan Drugs Act (H.R. 853).

Client expense: Not reported · Firm income: $150,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2347: Strengthening the Vaccines for Children Program Act of 2021 - Provisions related to COVID-19 vaccines H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3684: Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4418: SPIKE Act - Provisions related to prescription drug pricing transparency H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health H.R. 5416: Give Kids a Chance Act (RACE 2.0) - Provisions related to pediatric investigations S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 917: Short on Competition Act - Provisions related to FDA policy and prescription drug pricing S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2814: Vital Medication Affordability Act - Provisions related to 340B drug discount program S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program 21st Century Cures 2.0 (discussion draft) American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Executive Order 14036, Promoting Competitition in the American Economy (July 9, 2021) Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14005, Ensuring the Future Is Made in All of America by All of Americas Workers (January 25, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13987, Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security (January 20, 2021) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients DSHEA 2.0 HSA/FSA eligibility for Dietary Supplements Quit because of COVID Act Provisions related to Medicare's noninterference clause 340B Drug Pricing Program Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates S. Con. Res. Setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031. House of Representatives Build Back Better Act package- Rx and tax offset provisions Senate Build Back Better deliberations

HR 2144 - genetic counselors coverage under part B HR 853- Closing Loopholes for Orphan Drug Act S. 368 - Telehealth Modernization Act HR 3441- Substance Use Disorder Workforce Act S. 1438 - Opioid Workforce Act

Client expense: $15,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 5: Equality Act H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2347: Strengthening the Vaccines for Children Program Act of 2021 - Provisions related to COVID-19 vaccines H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2623: Camerons Law - Provisions related to orphan drugs H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4418: SPIKE Act - Provisions related to prescription drug pricing transparency H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health H.R. 5416: To amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities of the Food and Drug Administration regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 917: Short on Competition Act - Provisions related to FDA policy and prescription drug pricing S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2814: Vital Medication Affordability Act - Provisions related to 340B drug discount program S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program 21st Century Cures 2.0 (discussion draft) American Jobs Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period) Final Rule; Importation of Prescription Drugs Executive Order 14036, Promoting Competitition in the American Economy (July 9, 2021) Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14005, Ensuring the Future Is Made in All of America by All of Americas Workers (January 25, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13987, Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security (January 20, 2021) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

The 340B Drug Pricing Program; S.773 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes; H.R.3203 - To enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes; H.R. 853: Closing Loopholes for Orphan Drugs Act; H.R.3: Elijah E. Cummings Lower Drug Costs Now Act; H.R. 4390: PROTECT 340B Act of 2021; S. 2837: 340B Accountability Act of 2021; S. 2814: Vital Medication Affordability Act; H.R. 5463: Drug Pricing Transparency and Accountability Act

Client expense: $293,586 · Firm income: Not reported

Amendments to Section 340B of the Public Health Service Act regarding eligibility for rural referral centers and sole community hospitals in the federal discount drug purchasing program, including the Closing Loopholes for Orphan Drugs Act (H.R. 853).

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Amendments to Section 340B of the Public Health Service Act regarding eligibility for rural referral centers and sole community hospitals in the federal discount drug purchasing program, including the Closing Loopholes for Orphan Drugs Act (H.R. 853).

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 467, protecting patient access to life-saving COVID-19 drugs act of 2021 H.R. 959/S. 346, Black maternal health momnibus act of 2021; HSA/FSA for dietary supplements H.R. 796: Coverage for COVID-19 Treatment Act of 2021 - Provisions related to COVID-19 treatments H.R. 841, Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021 H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1978, Protecting Seniors Through Immunization Act H.R. 2484: Lowest Price for Patients Act - Provisions related to prescription drug pricing and transparency H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions HR 3236 - AMIGOS Act H.R. 3932: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections. - Provisions related to antimicrobial resistance policy issues S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1523: Drug Price Transparency Act of 2021 - Provisions related to prescription drug pricing transparency S. 1524: Health Care PRICE Transparency Act - Provisions related to prescription drug pricing transparency S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections. - Provisions related to antimicrobial resistance policy issues 21st Century Cures 2.0 (discussion draft) American Jobs Plan American Families Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Prescription drug take back and secure disposal policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) Interim Final Rule with comment period; Most Favord Nation (MFN) Model Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021 DHSEA 2.0 DISARM Act of Provisions related to antimicrobial drug development Infrastructure bill - potential inclusion of drug pricing proposals

HR 2144 - genetic counselors coverage under part B HR 853- Closing Loopholes for Orphan Drug Act S. 368 - Telehealth Modernization Act HR 3441- Substance Use Disorder Workforce Act S. 1438 - Opioid Workforce Act

Client expense: $15,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 796: Coverage for COVID-19 Treatment Act of 2021 - Provisions related to COVID-19 treatments H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 2078: Social and Economic Equity Promotion Act - CBO analyses H.R. 2366: STOP Fentanyl Act of 2021 H.R. 2484: Lowest Price for Patients Act - Provisions related to prescription drug pricing and transparency H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3932: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to antimicrobial resistance policy issues S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1523: Drug Price Transparency Act of 2021 - Provisions related to prescription drug pricing transparency S. 1524: Health Care PRICE Transparency Act - Provisions related to prescription drug pricing transparency S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: To establish a program to develop antimicrobial innovations targeting the most challenging pathogens and most threatening infections - Provisions related to antimicrobial resistance policy issues 21st Century Cures 2.0 (discussion draft) American Jobs Plan American Families Plan RFI for Advanced Research Projects Agency - Health (ARPA-H) HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Prescription drug take back and secure disposal policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Drug shortages policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) Interim Final Rule with comment period; Most Favord Nation (MFN) Model Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients

The 340B Drug Pricing Program; S.773 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes; H.R. 853: Closing Loopholes for Orphan Drugs Act; H.R.3203 - To enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes; H.R.3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R.19 - Lower Costs, More Cures Act of 2021;

Client expense: $272,268 · Firm income: Not reported

H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 387: Vaccinate More Americans Act of 2021 - Provisions related to COVID-19 vaccines H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 597: Pandemic Treatment Access and Affordability Act of 2021 - Provisions related to drug pricing and COVID-19 vaccines and treatments H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1391: Taxpayer Research and Coronavirus Knowledge Act of 2021 - Provisions related to COVID-19 health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals. - Provisions related to prescription drug importation H.R. 2347: To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes. - Provisions related to COVID-19 vaccines S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions - Provisions related to citizen petitions S. 670: To amend the Federal Food, Drug, and Cosmetic Act to accelerate development of therapies across the spectrum of rare diseases and conditions and facilitate patient access to such therapies, and for other purposes. - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 898: A bill to require reporting regarding certain drug price increases, and for other purposes. - Provisions related to prescription drug pricing transparency S. 917: A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages S. 920: To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals - Provisions related to prescription drug importation HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation policy issues Expanded access policy issues Supply chain policy issues Real world evidence policy issues Regenerative medicine policy issues Antimicrobial resistance (AMR) policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) Interim Final Rule with comment period; Most Favored Nation (MFN) Model Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of HHS Secretary Xavier Becerra Nominaton of USTR Katherine Tai Nomination of OMB Deputy Director Shalanda Young Nomination of CMS Administrator Chiquita Brooks-LaSure

H.R. 5: Equality Act H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 387: Vaccinate More Americans Act of 2021 - Provisions related to COVID-19 vaccines H.R. 467: Protecting Patient Access to Lifesaving COVID-19 Drugs Act of 2021 - Provisions related to COVID-19 treatments H.R. 597: Pandemic Treatment Access and Affordability Act of 2021 - Provisions related to drug pricing and COVID-19 vaccines and treatments H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program H.R. 1391: Taxpayer Research and Coronavirus Knowledge Act of 2021 - Provisions related to COVID-19 health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2078: Social and Economic Equity Promotion Act - CBO analyses H.R. 2181: To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals - Provisions related to prescription drug importation H.R. 2347: To amend title XIX of the Social Security Act to ensure adequate access to vaccines under the Medicaid program and the Vaccines for Children program, and for other purposes - Provisions related to COVID-19 vaccines S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions - Provisions related to citizen petitions S. 670: To amend the Federal Food, Drug, and Cosmetic Act to accelerate development of therapies across the spectrum of rare diseases and conditions and facilitate patient access to such therapies, and for other purposes - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 898: A bill to require reporting regarding certain drug price increases, and for other purposes - Provisions related to prescription drug pricing transparency S. 917: A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages S. 920: To amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals - Provisions related to prescription drug importation HHS PREP Act declaration relating to COVID-19 Drug cost and pricing policy issues Drug importation policy issues Expanded access policy issues Supply chain policy issues Real world evidence policy issues Regenerative medicine policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Foreign manufacturing policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Executive Order 14017, Americas Supply Chains (February 24, 2021) Executive Order 13948, Lowering Drug Prices by Putting America First (September 13, 2020) Interim Final Rule with comment period; Most Favored Nation (MFN) Model Executive Order 13944, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of HHS Secretary Xavier Becerra Nominaton of USTR Katherine Tai Nomination of HHS Assistant Secretary Rachel Levine Nomination of OMB Deputy Director Shalanda Young Nomination of CMS Administrator Chiquita Brooks-LaSure

The 340B Drug Pricing Program; S.773 - A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes; H.R. 853: Closing Loopholes for Orphan Drugs Act; H.R.1319 - American Rescue Plan Act of 2021.

Client expense: $292,698 · Firm income: Not reported

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