Making Pharmaceutical Markets More Competitive Act

Discussions pertinent to health care group purchasing organizations (GPOs) role in helping to prevent drug shortages Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2018 (proposed Alexander-Murray legislation) Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored H.R.4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes Monitored HR 6 SUPPORT for Patients and Communities Act

Client expense: Not reported · Firm income: $130,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.

Client expense: $870,000 · Firm income: Not reported

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $900,000 · Firm income: Not reported

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. Opioid abuse. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1892: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $1,040,000 · Firm income: Not reported

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.

Client expense: $860,000 · Firm income: Not reported

Discussions pertinent to health care group purchasing organizations (GPOs) role in helping to prevent drug shortages Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act of 2017 (proposed Alexander-Murray legislation) Monitored S 2312 Helping Ensure Low-income patients have Access to Care and Treatment (HELP) Act Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored HR 4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes. Monitored HR6 SUPPORT for Patients and Communities Act

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

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - pharmacist-patient communications, S. 2554, Patient Right to Know Drug Prices Act (Collins) - pharmacist-patient communications, reporting of biosimilar pay-for-delay settlements S. 3194, Capping Prescription Costs Act (Warren) - capping prescription copays H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) -pharmaceutical price transparency in DTC advertising H.R. 6340, Capping Prescription Costs Act (Rosen) - capping prescription copays H.R. 6478, Biosimilars Competition Act (Sarbanes) - reporting of pay-for-delay settlements H.R. 6576, Drug-Price Transparency in Communications Act (Schakowsky) - disclosure of drug prices in DTC advertising H.R. 6733, Know the Cost Act (Carter) - pharmacist-patient communications Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to opioids; issues relating to prescription drug price blueprint; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - information on drug prices S. 2554, Patient Right to Know Drug Prices Act (Collins) - information on drug prices H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to opioids; issues relating to prescription drug price blueprint; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Discussions pertinent to health care group purchasing organizations (GPOs) role in helping to prevent drug shortages Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2018 (proposed Alexander-Murray legislation) Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored H.R.4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes Monitored HR 6 SUPPORT for Patients and Communities Act

Client expense: Not reported · Firm income: $130,000

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act of 2017 (proposed Alexander-Murray legislation) Monitored S 1835 The Lower Premiums Through Reinsurance Act of 2017 Monitored S 2312 Helping Ensure Low-income patients have Access to Care and Treatment (HELP) Act Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored HR 4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes.

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

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $800,000 · Firm income: Not reported

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - information on drug prices S. 2554, Patient Right to Know Drug Prices Act (Collins) - information on drug prices H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to opioids; issues relating to prescription drug price blueprint; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2017 (proposed Alexander-Murray legislation) Monitored S 1835 The Lower Premiums Through Reinsurance Act of 2017 Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored H.R.4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes

Client expense: Not reported · Firm income: $130,000

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) HR 277 American Health Care Reform Act of 2017 (all sections of full text) Discussions seeking guidance to minimize supply chain shortages for areas hit by natural disasters Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act of 2017 (proposed Alexander-Murray legislation) Monitored The Lower Premiums Through Reinsurance Act of 2017 (proposed Collins-Nelson legislation) Monitored S 2312 Helping Ensure Low-income patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored PL 115-141 Consolidated Appropriations Act, 2018 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored HR 4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes.

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

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. Opioid abuse. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1892: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $970,000 · Firm income: Not reported

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - information on drug prices S. 2554, Patient Right to Know Drug Prices Act (Collins) - information on drug prices H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to opioids; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) HR 277 American Health Care Reform Act of 2017 (all sections of full text) Discussions seeking guidance to minimize supply chain shortages for areas hit by natural disasters Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2017 (proposed Alexander-Murray legislation) Monitored The Lower Premiums Through Reinsurance Act of 2017 (proposed Collins-Nelson legislation) Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored PL 115-141 Consolidated Appropriations Act, 2018 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored H.R.4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes

Client expense: Not reported · Firm income: $130,000

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) -- pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to opioids; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $1,710,000 · Firm income: Not reported

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) HR 277 American Health Care Reform Act of 2017 (all sections of full text) Discussions involving Graham-Cassidy-Heller-Johnson (GCHJ) substitute legislation to HR 1628, to provide for reconciliation pursuant to Title II of the concurrent resolution on the budget for fiscal year 2017 Discussions pertaining to HR 1628 American Health Care Act of 2017 (all sections of full text) Discussions seeking guidance to minimize supply chain shortages for areas hit by natural disasters Educational discussions involving effectiveness of hospital trauma efforts HR 2 - Buschon Amendment (oppose) Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017

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

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017.

Client expense: $1,290,000 · Firm income: Not reported

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) HR 277 American Health Care Reform Act of 2017 (all sections of full text) Discussions involving Graham-Cassidy-Heller-Johnson (GCHJ) substitute legislation to HR 1628, to provide for reconciliation pursuant to Title II of the concurrent resolution on the budget for fiscal year 2017 Discussions pertaining to HR 1628 American Health Care Act of 2017 (all sections of full text) Discussions seeking guidance to minimize supply chain shortages for areas hit by natural disasters Educational discussions involving effectiveness of hospital trauma efforts HR 2 - Buschon Amendment (oppose) Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017

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

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 934, FDA Reauthorization Act (Alexander) - user fee programs, prescription drug and medical device amendments S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) -- pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2430, FDA Reauthorization Act (Walden) - user fee programs, prescription drug and medical device amendments H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to opioids; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017.

Client expense: $660,000 · Firm income: Not reported

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) Discussions involving potential reform of health care delivery and payment systems implemented by The Affordable Care Act HR 277 American Health Care Reform Act of 2017 (all sections of full text) Discussions involving US Senate Graham-Cassidy health care legislation Discussions pertaining to HR 1628 American Health Care Act of 2017 (all sections of full text) Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored discussions that would result in additional federal regulation of Group Purchasing Organizations Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017

Client expense: Not reported · Firm income: $130,000

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA) and Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Biosimilars Naming. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. Prescription Drug Costs. H.R.2841: FAST Generics Act of 2015. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1314: Bipartisan Budget Act of 2015. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. S.3056: CREATES Act of 2016. H.R.2212/S.974: CREATES Act of 2017. H.R.6043/S.3335: Fair Accountability and Innovative Research Drug Pricing Act of 2016. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Drug Importation. H.R.2430/S.934: FDA Reauthorization Act of 2017. FDA Commissioner Nomination.

Client expense: $780,000 · Firm income: Not reported

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 934, FDA Reauthorization Act (Alexander) - user fee programs, prescription drug and medical device amendments S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) -- pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2430, FDA Reauthorization Act (Walden) - user fee programs, prescription drug and medical device amendments H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $1,700,000 · Firm income: Not reported

American Health Care Act (AHCA), H.R. 1628 Prescription Drug Price Transparency Act, H.R. 1316 PHA section, 21st Century Cures Act (Public Law: 114-255): Home infusion provisions (section 5004, section 5012) Improving Transparency and Accuracy in Medicare Part D Spending Act, H.R. 1038/S.413 Pharmacy and Medically Underserved Areas, H.R.592/S.109 Ensuring Seniors Access to Local Pharmacies Act of 2017, H.R.1939 FAST Generics Act of 2017, H.R.2051 CREATES Act of 2017, H.R.2212/S.974 ACCESS Act of 2017, H.R. 1704 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2017 Making Pharmaceutical Markets More Competitive Act, H.R.2562/S.1115 Increasing Competition in Pharmaceuticals Act, H.R.297 Protecting Access to Care, H.R.1215 Preserve Access to Affordable Generics Act, S.124 Protecting Seniors' Access to Medicare Act of 2017, H.R.847/S.260

Client expense: $370,000 · Firm income: Not reported

Discussions involving potential reform of health care delivery and payment systems implemented by The Affordable Care Act HR 277 American Health Care Reform Act of 2017 (all sections of full text) Discussions pertaining to the Better Care Reconciliation Act (BCRA) (all sections of full text) Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored discussions that would result in additional federal regulation of Group Purchasing Organizations Monitored Hatch/Senate Finance Committee examination of potential reforms to the Stark Law Monitored HR 2562 Making Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) Discussions involving potential reform of health care delivery and payment systems implemented by The Affordable Care Act Discussions involving nominations to federally authorized commissions HR 277 American Health Care Reform Act of 2017 (all sections of full text) Discussions pertaining to the Better Care Reconciliation Act (BCRA), (all sections of full text) Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored discussions that would result in additional federal regulation of Group Purchasing Organizations Monitored Hatch/Senate Finance Committee examination of potential reforms to the Stark Law Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017

Client expense: Not reported · Firm income: $130,000