FDA Modernization Act of 2021

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1016 - all provisions; H.R. 2565 and S. 2952 (FDA Modernization Act) - all provisions; continuation of outreach regarding Animal Welfare Act issues related to utilization of animals with biomedical research; continuation of outreach regarding animal transportation issues for purposes of biomedical research.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE

HR 1016 - all provisions; H.R. 2565 and S. 2952 (FDA Modernization Act) - all provisions; continuation of outreach regarding Animal Welfare Act issues related to utilization of animals with biomedical research; continuation of outreach regarding animal transportation issues for purposes of biomedical research.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to animal welfare; FY 2023 Appropriations, Puppy Protection Act (S. 1835/H.R. 2840), Shark Fin Sales Elimination Act (S. 1106), Prevent All Soring Tactics (PAST) Act (S. 2295), Humane Cosmetics Act (S. 3357/H.R. 6207), Preventing Future Pandemics Act of 2021 (S. 37/H.R. 151), FDA Modernization Act of 2021 (S. 2952/H.R.2565), The Humane Cosmetics Act (S. 3357), COMPETES Act (H.R. 4521)/the U.S. Innovation and Competition Act (S. 1260).

Client expense: Not reported · Firm income: $30,000

Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, White House Office

H.R. 4310, Minks in Narrowly Kept Spaces are Superspreaders Act (MINKS Act); H.R. 4291/S. 2861, Opportunities for Fairness in Farming (OFF) Act; H.R. 2325, Bear Protection Act; H.R. 2565/S. 2952, FDA Modernization Act; S. 5002, FDA Modernization Act 2.0; H.R. 5441/S. 2295, Prevent All Soring Tactics (PAST) Act; H.R. 3355, Saving America's Forgotten Equines (SAFE) Act; S. 2732, John Stringer Rainey SAFE Act; H.R. 3335, Greyhound Protection Act; H.R. 2811/S. 1106, Shark Fin Sales Elimination Act(and inclusion in NDAA); H.R. 2840/S. 1385, Puppy Protection Act; H.R. 263/S. 1210, Big Cat Public Safety Act; H.R. 921, Horse Transportation Safety Act; H.R. 151/S. 37, Preventing Future Pandemics Act; H.R. 263, Big Cat Public Safety Act; H.R. 405/S. 4157 Lead Endangers Animals Daily (LEAD) Act; H.R. 917, Kangaroo Protection Act; H.R. 921, Horse Transportation Safety Act; H.R. 1016, Animal Cruelty Enforcement Act; H.R. 1319, American Rescue Plan Act of 2021; H.R. 1442, Providing Responsible Emergency Plans for Animals at Risk of Emerging Disasters (PREPARED) Act; H.R. 4521, United States Innovation and Competition Act; H.R. 7631, Veterans for Mustangs Act; H.R. 7787, HENRY Act; S. 3472, Bear Poaching Elimination Act; S. 4288, Reducing Animal Testing Act; H.R. 9309, the Animal Fighting Amendments Act of 2022; Omnibus Appropriations for FY2023 Senate Amendment 5002 to H.R.4521 Ron Johnson Motion to Instruct on mink provision re: Senate Amendment 5002 to H.R. 4521 FY23 House and Senate Appropriations Legislation for Labor, Health and Human Services, and Education, and Related Agencies; FY23 House and Senate Appropriations Legislation for Interior, Environment, and Related Agencies; FY23 House and Senate Appropriations Legislation for Commerce, Justice, Science, and Related Agencies; FY23 House and Senate Appropriations Legislation for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Centers for Disease Control and Prevention (CDC) Policy on Canine Imports from 113 Countries Frozen by Biden Administration. Creation of an Animal Cruelty Crimes Unit at the Department of Justice. Issues related to allowing certain canine imports and animal testing. Enforcement of Preventing Animal Cruelty and Torture (PACT) Act. Issues related to wild horse roundups, incarcerations, and surgical sterilization, and implementation and use of PZP birth control. Issues related to freezing grazing permits on Herd Management Areas on federal lands to protect wild horses. Discussions of the following bills not yet introduced: Restoring Our American Mustangs (ROAM) Act Permanently Uniting Pets Stateside (PUPS) Act CECIL Act Pet Fax Act

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

Government targets: Agriculture, Dept of (USDA), Bureau of Land Management (BLM), Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), SENATE, Vice President of the U.S., White House Office

H.R. 2565, S. 2952, FDA Modernization Act of 2021, All provisions.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- S. 2952, FDA Modernization Act of 2021 - S. 3472, Bear Poaching Elimination Act - S. 1210, Big Cat Public Safety Act - S. 4157, LEAD Act of 2022 - S. 5002, FDA Modernization Act 2.0. - Legislation related to domestic mink farming - Legislation related to wild horses

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Healthcare issues related to clinical laboratories; H.R. 8188/S. 4449, the Saving Access to Laboratory Services Act (SALSA), provisions relating to reform of Medicare reimbursement for clinical laboratory services under Section 216 of the Protecting Access to Medicare Act, Pub. L. 113-93; H.R. 4128/S. 2209, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, included as Subtitle C of Title VIII of S. 4348, the FDA Safety and Landmark Advancements Act (FDASLA), provisions relating to FDA oversight of laboratory-developed tests; H.R. 4040, the Advancing Telehealth Beyond COVID-19 Act, H.R. 6202, the Telehealth Extension Act, and H.R. 7573/S. 3593, the Telehealth Extension and Evaluation Act, provisions relating to extension of Medicare coverage of telehealth services and limitations on payment for certain laboratory tests; H.R. 8152, the American Data Privacy and Protection Act (ADPPA), provisions relating to data privacy; S. 3799, the PREVENT Pandemics Act, provisions relating to demographic data reporting obligations for laboratories; H.R. 5030/S. 2706, the DIVERSE Trials Act, provisions relating to enhancing diversity in clinical trials and data collection and reporting by clinical laboratories; H.R. 2565/S. 2952, the FDA Modernization Act, provisions relating to biomedical research; H.R.3173/S. 3018, the Improving Seniors Timely Access to Care Act, provisions relating to prior authorization of health care services; Federal policy related to implementation of the Families First Coronavirus Response Act, Pub. L. 116-127, provisions relating to coverage of and funding for COVID-19 diagnostic tests; Federal policy related to implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. 116-136, provisions relating to coverage and reimbursement of COVID-19 diagnostic tests and Medicare reimbursement for clinical laboratory tests; Federal policy related to supply chain issues affecting pre-clinical biomedical research for drug development; Federal policy relating to the National Correct Coding Initiative and manual instructions inconsistent with American Medical Association guidelines for Current Procedural Terminology (CPT) coding; and Federal policy relating to availability of Current Procedural Terminology (CPT) codes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Bills -H.R. 2163/S. 464 - Safe Step Act -S.1773 - Prescription Drug Pricing Dashboard Act -H.R. 5376 - Build Back Better Act -H.R. 3684- Infrastructure Investment and Jobs Act -H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act -S.2076/H.R. 3932 PASTEUR Act -S. 3799- PREVENT Pandemics Act -H.R.4521 - COMPETES Act of 2022 -S.1260 - United States Innovation and Competition Act of 2021 -H.R.6963 - Accelerated Approval Integrity Act of 2022 -H.R.6996 - Accelerating Access for Patients Act of 2022 -H.R. 2565 / S.2952 the FDA Modernization Act -H.R. 6972 - Give Kids a Chance Act -H.R. 1730 - STAT Act -H.R. 7032 - Increasing Transparency in Generic Drug Applications Act -H.R. 5030/S. 2706 - DIVERSE Trials Act -H.R. 6584 - DEPICT Act -H.R. 9476- Influenza Act of 2022 Issues -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing -Issues related to healthcare legislation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to health equity, diversity, and inclusion in clinical trials -Issues related to advanced development and procurement of medical countermeasures (MCMs) -Issues related to patient assistance and access -Issues relating to privacy and securing the data of and personal information of consumers -Issues relating to medical research data -Issues relating to screening and diagnostics -Issues related to public health preparedness and response -Issues related to awareness about diabetic eye diseases in minority populations

Client expense: $1,630,000 · Firm income: Not reported

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

H.R. 2471 Consolidated Appropriations Act, FY2022 S.2076/H.R. 3932 PASTEUR Act H.R.7667 - Food and Drug Amendments of 2022 S.4348 - FDASLA Act of 2022 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act H.R.3085 - ENACT Act of 2021 -Issues related to public health protection including influenza development and preparedness -Issues related to antimicrobial and antiviral research and product development -Issues related to novel coronavirus and COVID-19 research and product development -Issues related to drug development including PDUFA and Cures 2.0

Client expense: $1,630,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General Parkinson's disease information about symptoms, triggers, health coverage, health costs, social determinants of health related to Parkinson's disease and data collection, research, and health access for underserved communities. H.R. 8585/S. 4851, the National Plan to End Parkinson's Act - to require the U.S. Department of Health and Human Services (HHS) to carry out a project to prevent and cure Parkinson's disease. Among other components of the project, HHS must (1) implement and periodically update a national plan to coordinate and guide efforts to prevent and cure the disease; (2) improve diagnosis, treatment, and care of those with the disease; and (3) address health and other disparities related to the disease. HHS must also conduct annual assessments on the preparation for and response to the increased burden of Parkinson's disease. In addition, the bill establishes a council, comprised of federal and nonfederal stakeholders, to advise HHS on and make recommendations concerning the prevention and cure of Parkinson's disease. Establishing Parkinson's disease ICD-10-CM codes to assist in the continuation and coordination of care and to allow researchers to gather more data to study the progression of Parkinson's among people living with the disease. Expanding access to health care for people living with Parkinson's via telehealth by removing Medicare telehealth geographic and originating site restrictions, extending coverage and reimbursement for health care providers who bill Medicare for providing services via telehealth (including seeing new patients and audio-only telehealth for clinically appropriate services/visits), ensuring payment parity for telehealth and in-person services, and removing Medicare in-person requirements for accessing mental health services via telehealth. H.R. 2617, the Consolidated Appropriations Act, 2023 Establishing separate Medicare payment requirements for diagnostic radiopharmaceuticals, including DaTscans, so health care providers are adequately reimbursed for furnishing diagnostic tests to help validate patients Parkinsons diagnoses. S. 2609/H.R. 4479, Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2021 S. 464/H.R. 2163, the Safe Step Act - to amend the Employee Retirement Income Security Act of 1974 (ERISA) to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol to enable people living with Parkinsons disease to access the medications they need to best manage their disease S.4906 Advocating for reauthorization of CDCs National Neurological Conditions Surveillance System (NNCSS) S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT), and Pandemics Act S. 253/H.R.8454, the Cannabidiol and Marihuana Research Expansion Act/ Medical Marijuana and Cannabidiol Research Expansion Act S. 1467/H.R. 2916, the VA Medicinal Cannabis Research Act H.R. 5657, the Medical Marijuana Research Act H.R. 3617, the Marijuana Opportunity Reinvestment and Expungement Act H.R. 2916/S. 1467, the VA Medical Cannabis Research Act of 2021 H.R. 3105, the Common Sense Cannabis Reform for Veterans, Small Businesses, and Medical Professionals Act S. 1670/H.R. 3321, the Credit for Caring Act H.R. 253, the Adult Day Care Center Enhancement Act H.R. 6000, the Cures 2.0 Act H.R. 4521, the America COMPETES Act of 2022 H.R. 2565/S. 2952, the FDA Modernization Act of 2021 H.R. 5435 BRAIN (Bringing Regulatory Advances Into Neuroscience) Act of 2021 S. 3427, the Neuroscience Center of Excellence Act of 2021 H.R. 6584, the DEPICT (Diverse and Equitable Participation in Clinical Trials) Act S. 331, ABLE (Achieving a Better Life Experience) Age Adjustment Act

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

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE

H.R. 263 - Big Cat Public Safety Act - entire bill. H.R.1016 - Animal Cruelty Enforcement Act of 2021 - entire bill. S.1210 - Big Cat Public Safety Act - entire bill. H.R.2565 - FDA Modernization Act of 2021 - entire bill. S 2952 - FDA Modernization Act of 2021 - issues related to animal safety. HR 2325 - Bear Protection Act of 2021 - entire bill. S 3472 - Bear Poaching Elimination Act of 2022 - entire bill. H.R. 4310 - Minks in Narrowly Kept Spaces are Superspreaders Act - entire bill. H.R.4521 - America COMPETES Act of 2022 - issues related to animal safety.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4310, Minks in Narrowly Kept Spaces are Superspreaders Act (MINKS Act); H.R. 4291/S. 2861, Opportunities for Fairness in Farming (OFF) Act; H.R. 2325, Bear Protection Act; H.R. 2565/S. 2952, FDA Modernization Act; S. 5002, FDA Modernization Act 2.0; H. 5441/S. 2295, Prevent All Soring Tactics (PAST) Act; H.R. 3355, Saving America's Forgotten Equines (SAFE) Act; S. 2732, John Stringer Rainey SAFE Act; H.R. 3335, Greyhound Protection Act; H.R. 2811/S. 1106, Shark Fin Sales Elimination Act; H.R. 2840/S. 1385, Puppy Protection Act; H.R. 263/S. 1210, Big Cat Public Safety Act; H.R. 921, Horse Transportation Safety Act; H.R. 151/S. 37, Preventing Future Pandemics Act; H.R. 263, Big Cat Public Safety Act; H.R. 405/S. 4157 Lead Endangers Animals Daily (LEAD) Act; H.R. 917, Kangaroo Protection Act; H.R. 921, Horse Transportation Safety Act; H.R. 1016, Animal Cruelty Enforcement Act; H.R. 1319, American Rescue Plan Act of 2021; H.R. 1442, Providing Responsible Emergency Plans for Animals at Risk of Emerging Disasters (PREPARED) Act; H.R. 4521, United States Innovation and Competition Act; H.R. 7631, Veterans for Mustangs Act; H.R. 7787, HENRY Act; S. 3472, Bear Poaching Elimination Act Senate Amendment 5002 to H.R.4521 Ron Johnson Motion to Instruct on mink provision re: Senate Amendment 5002 to H.R. 4521 FY23 House and Senate Appropriations Legislation for Labor, Health and Human Services, and Education, and Related Agencies; FY23 House and Senate Appropriations Legislation for Interior, Environment, and Related Agencies; FY23 House and Senate Appropriations Legislation for Commerce, Justice, Science, and Related Agencies; FY23 House and Senate Appropriations Legislation for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Centers for Disease Control and Prevention (CDC) Policy on Canine Imports from 113 Countries Frozen by Biden Administration. Creation of an Animal Cruelty Crimes Unit at the Department of Justice. Issues related to allowing certain canine imports and animal testing. Enforcement of Preventing Animal Cruelty and Torture (PACT) Act. Issues related to wild horse roundups, incarcerations, and surgical sterilization, and implementation and use of PZP birth control. Issues related to freezing grazing permits on Herd Management Areas on federal lands to protect wild horses. Discussions of the following bills not yet introduced: Restoring Our American Mustangs (ROAM) Act Permanently Uniting Pets Stateside (PUPS) Act CECIL Act Pet Fax Act

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

Government targets: Agriculture, Dept of (USDA), Bureau of Land Management (BLM), Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), SENATE, White House Office

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2471 Consolidated Appropriations Act, FY2022 S.2076/H.R. 3932 PASTEUR Act H.R.7667 - Food and Drug Amendments of 2022 S.4348 - FDASLA Act of 2022 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act H.R.3085 - ENACT Act of 2021 -Issues related to public health protection including influenza development and preparedness -Issues related to antimicrobial and antiviral research and product development -Issues related to novel coronavirus and COVID-19 research and product development -Issues related to drug development including PDUFA and Cures 2.0

Client expense: $2,430,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to animal welfare; FY 2023 Appropriations, Puppy Protection Act (S. 1835/H.R. 2840), Shark Fin Sales Elimination Act (S. 1106), Prevent All Soring Tactics (PAST) Act (S. 2295), Humane Cosmetics Act (S. 3357/H.R. 6207), Preventing Future Pandemics Act of 2021 (S. 37/H.R. 151), FDA Modernization Act of 2021 (S. 2952/H.R.2565), The Humane Cosmetics Act (S. 3357), COMPETES Act (H.R. 4521)/the U.S. Innovation and Competition Act (S. 1260).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.

Client expense: $720,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE

HR 1016 - all provisions; H.R. 2565 and S. 2952 (FDA Modernization Act) - all provisions; continuation of outreach regarding Animal Welfare Act issues related to utilization of animals with biomedical research; continuation of outreach regarding animal transportation issues for purposes of biomedical research.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

- S. 2952, FDA Modernization Act of 2021 - S. 3472, Bear Poaching Elimination Act - S. 1210, Big Cat Public Safety Act - S. 4157, LEAD Act of 2022 - S. 5002, FDA Modernization Act 2.0. - Legislation related to domestic mink farming - Legislation related to wild horses

Client expense: Not reported · Firm income: $30,000

Government targets: SENATE

H.R. 2565, S. 2952, FDA Modernization Act of 2021, All provisions. H.R. 7667, Food and Drug Amendments of 2022, Issues pertaining to animal research use in pre-clinical research. S. 4348, FDASLA Act of 2022, Issues pertaining to animal research use in pre-clinical research.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4310, Minks in Narrowly Kept Spaces are Superspreaders Act (MINKS Act); H.R. 4291/S. 2861, Opportunities for Fairness in Farming (OFF) Act; H.R. 2325, Bear Protection Act; H.R. 2565/S. 2952, FDA Modernization Act; H. 5441/S. 2295, Prevent All Soring Tactics (PAST) Act; H.R. 3355, Saving America's Forgotten Equines (SAFE) Act; S. 2732, John Stringer Rainey SAFE Act; H.R. 3335, Greyhound Protection Act; H.R. 2811/S. 1106, Shark Fin Sales Elimination Act; H.R. 2840/S. 1385, Puppy Protection Act; H.R. 263/S. 1210, Big Cat Public Safety Act; H.R. 921, Horse Transportation Safety Act; H.R. 151/S. 37, Preventing Future Pandemics Act; H.R. 263, Big Cat Public Safety Act; H.R. 405/S. 4157 Lead Endangers Animals Daily (LEAD) Act; H.R. 917, Kangaroo Protection Act; H.R. 921, Horse Transportation Safety Act; H.R. 1016, Animal Cruelty Enforcement Act; H.R. 1319, American Rescue Plan Act of 2021; H.R. 1442, Providing Responsible Emergency Plans for Animals at Risk of Emerging Disasters (PREPARED) Act; H.R. 4521, United States Innovation and Competition Act; H.R. 7631, Veterans for Mustangs Act; H.R. 7787, HENRY Act; S. 3472, Bear Poaching Elimination Act Senate Amendment 5002 to H.R.4521 Ron Johnson Motion to Instruct on mink provision re: Senate Amendment 5002 to H.R. 4521 FY23 House and Senate Appropriations Legislation for Labor, Health and Human Services, and Education, and Related Agencies; FY23 House and Senate Appropriations Legislation for Interior, Environment, and Related Agencies; FY23 House and Senate Appropriations Legislation for Commerce, Justice, Science, and Related Agencies; FY23 House and Senate Appropriations Legislation for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Centers for Disease Control and Prevention (CDC) Policy on Canine Imports from 113 Countries Frozen by Biden Administration. Creation of an Animal Cruelty Crimes Unit at the Department of Justice. Issues related to allowing certain canine imports and animal testing. Enforcement of Preventing Animal Cruelty and Torture (PACT) Act. Issues related to wild horse roundups, incarcerations, and surgical sterilization, and implementation and use of PZP birth control. Issues related to freezing grazing permits on Herd Management Areas on federal lands to protect wild horses. Discussions of the following bills not yet introduced: Restoring Our American Mustangs (ROAM) Act Permanently Uniting Pets Stateside (PUPS) Act CECIL Act Pet Fax Act

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

Government targets: Agriculture, Dept of (USDA), Bureau of Land Management (BLM), Centers For Disease Control & Prevention (CDC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), SENATE, White House Office

Healthcare issues related to clinical laboratories; H.R. 8188/S. 4449, the Saving Access to Laboratory Services Act (SALSA), provisions relating to reform of Medicare reimbursement for clinical laboratory services under Section 216 of the Protecting Access to Medicare Act, Pub. L. 113-93; H.R. 4128/S. 2209, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, included as Subtitle C of Title VIII of S. 4348, the FDA Safety and Landmark Advancements Act (FDASLA), provisions relating to FDA oversight of laboratory-developed tests; H.R. 4040, the Advancing Telehealth Beyond COVID-19 Act, H.R. 6202, the Telehealth Extension Act, and H.R. 7573/S. 3593, the Telehealth Extension and Evaluation Act, provisions relating to extension of Medicare coverage of telehealth services and limitations on payment for certain laboratory tests; H.R. 8152, the American Data Privacy and Protection Act (ADPPA), provisions relating to data privacy; S. 3799, the PREVENT Pandemics Act, provisions relating to demographic data reporting obligations for laboratories; H.R. 5030/S. 2706, the DIVERSE Trials Act, provisions relating to enhancing diversity in clinical trials and data collection and reporting by clinical laboratories; H.R. 2565/S. 2952, the FDA Modernization Act, provisions relating to biomedical research; H.R. 8693, the No Cost for Monkeypox Testing Act, provisions relating to third party payer coverage of monkeypox testing; S. 4734, the Patent Eligibility Restoration Act, provisions relating to patent subject matter eligibility; Federal policy related to implementation of the Families First Coronavirus Response Act, Pub. L. 116-127, provisions relating to coverage of and funding for COVID-19 diagnostic tests; Federal policy related to implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. 116-136, provisions relating to coverage and reimbursement of COVID-19 diagnostic tests and Medicare reimbursement for clinical laboratory tests; Federal policy relating to the National Correct Coding Initiative and manual instructions inconsistent with American Medical Association guidelines for Current Procedural Terminology (CPT) coding; and Federal policy relating to availability of Current Procedural Terminology (CPT) codes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 263 - Big Cat Public Safety Act - entire bill. H.R.1016 - Animal Cruelty Enforcement Act of 2021 - entire bill. S.1210 - Big Cat Public Safety Act - entire bill. H.R.2565 - FDA Modernization Act of 2021 - entire bill. S 2952 - FDA Modernization Act of 2021 - issues related to animal safety. HR 2325 - Bear Protection Act of 2021 - entire bill. S 3472 - Bear Poaching Elimination Act of 2022 - entire bill. H.R. 4310 - Minks in Narrowly Kept Spaces are Superspreaders Act - entire bill. H.R.4521 - America COMPETES Act of 2022 - issues related to animal safety.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General Parkinson's disease information about symptoms, triggers, health coverage, health costs, social determinants of health related to Parkinson's disease and data collection, research, and health access for underserved communities Advocating for Parkinson's patients during COVID-19, including extension of health care subsidies Advocating for proposed repeal of Department of Health and Human Services rule entitled Securing Updated and Necessary Statutory Evaluations Timely Advocating on for more specific Parkinson's disease ICD-10-CM codes to assist in the continuation and coordination of care and allow researchers to have data to study the disease progression Advocating for expanding access to care via telehealth S.4906 Advocating for reauthorization of CDCs National Neurological Conditions Surveillance System (NNCSS) S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT), and Pandemics Act S. 253/H.R.8454, the Cannabidiol and Marihuana Research Expansion Act/ Medical Marijuana and Cannabidiol Research Expansion Act S. 1467/H.R. 2916, the VA Medicinal Cannabis Research Act H.R. 5657, the Medical Marijuana Research Act H.R. 3617, the Marijuana Opportunity Reinvestment and Expungement Act H.R. 2916/S. 1467, the VA Medical Cannabis Research Act of 2021 H.R. 3105, the Common Sense Cannabis Reform for Veterans, Small Businesses, and Medical Professionals Act S. 1670/H.R. 3321, the Credit for Caring Act H.R. 253, the Adult Day Care Center Enhancement Act S. 464/H.R. 2163, the Safe Step Act H.R. 3013, the COVID Vaccine Transportation Access Act H.R. 2503, the Social Determinants Accelerator Act of 2021 H.R. 6000, the Cures 2.0 Act H.R. 4521, the America COMPETES Act of 2022 H.R. 2565/S. 2952, the FDA Modernization Act of 2021 H.R. 5435 BRAIN Act of 2021 S. 3427, the Neuroscience Center of Excellence Act of 2021 H.R. 6584, the DEPICT Act S.Res. 577, A resolution designating April 2022 as "Parkinson's Awareness Month" S. 331, ABLE Age Adjustment Act H.R. 5376, the Inflation Reduction Act of 2022 H.R. 8585/S. 4851, the National Plan to End Parkinson's Act

Client expense: $31,190 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE

Supporting the Traveling Exotic Animal and Public Safety Protection Act (HR5999/ S3220), with outreach requesting cosponsorship, support, and committee hearing; all provisions related to and supporting ending the suffering of animals in US traveling acts, and to address the inherent health and safety risks such events pose to animals, workers, and the public. Support the following measures to the extent they protect animals from harm, end animal suffering, and promote conservation of wild populations (supporting ADI's overarching goal for longstanding change to end animal suffering and to promote conservation of wild populations): TEAPSPA (HR5999/ S3220); AFTER (Animal Freedom from Testing, Experiments, and Research) Act (HR5244); Alternatives to Animals for Regulatory Fairness (AARF) Act (HR1905); Animal Cruelty Enforcement Act HR1016; Bear Protection Act (HR2325); Big Cat & Public Safety Act (HR263/ S1210); Break Free from Plastic Pollution Act (HR2238); Captive Primate Safety Act HR3135/ S1588; Critically Endangered Animals Conservation Act (HR1569); Ejiao Act (HR5203); End Palm Oil Deforestation Act HR5863; Environmental Justice for All Act (HR2021/ S872); Extinction Crisis Emergency Act HR4182; Federal fur action; FDA Modernization Act (HR2565/S2952); Federal fur action; Food and Drug Amendments Act HR7667; FOREST (Fostering Overseas Rule of law and Environmentally Sound Trade) Act S2950; Healthy Future Students and Earth Pilot Program Act HR4108; HRes69 (National Biodiversity Strategy); HRes1163; Humane Cosmetics Act HR6207/ S3357; Humane Research & Testing Act (HR1744); Minks in Narrowly Kept Spaces (MINKS) are Superspreaders Act (HR4310); Ocean-Based Climate Solutions Act HR3764; PIGS Act HR7004; President Bidens Earth Day Executive Order; Preventing all soring tactics (PAST) Act HR5441/ S2295; Preventing Future Pandemics Act (HR151/ S37/ S4074); Prohibit Wildlife Killing Contests Act HR7398; REDUCE Act S2645; Reducing Waste in National Parks Act HR5533 /S2960; Right Whale Coexistence Act (HR6785/ S3664); Safeguarding Americas Future and Environment (SAFE) Act HR2872; Sea Turtle Rescue Assistance Grant Program HR7918; Shark Fin Sales Elimination Act (S1106); Strengthening Welfare in Marine Settings (SWIMS) Act HR8514/ S4740; Surface Transportation Reauthorization Act S1931 (wildlife connectivity provisions); Tropical forest /deforestation Act HR241; Veterans for Mustangs Act HR7631; Wild Horse & Burro Protection Act HR6635; Wildlife Conservation & Anti-Trafficking Act HR6059. Opposing the following bills, which seek to reduce protections for animals, and/or their ecosystems and habitats: HR8136; Listing Reform Act HB4370; Trust the Science Act HR7766; permitting reform that endangers ESA & species, and precludes judicial review. Mixed, with amendments proposed: FDASLA S4348---support NAMs provisions (section 501); urge amendment to replace section 807 w Humane Cosmetics Act (HR6207/ S3357) text; oppose section 614 (preemption clause) absent such amendment. Monitoring, but taking a neutral or no position on, the following bills: Inflation Reduction Act; Recovering Americas Wildlife Act (HR2773/ S2372).

Client expense: $7,684 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Council on Environmental Quality (CEQ), Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), President of the U.S., SENATE, U.S. Fish & Wildlife Service (USFWS)

HR 1016 - all provisions; H.R. 2565 and S. 2952 (FDA Modernization Act) - all provisions; continuation of outreach regarding Animal Welfare Act issues related to utilization of animals with biomedical research; continuation of outreach regarding animal transportation issues for purposes of biomedical research.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Work related to passage of the FDA Modernization Act of 2021 (S. 2952) (H.R. 2565)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Supporting the Traveling Exotic Animal and Public Safety Protection Act (HR5999/ S3220), with outreach requesting cosponsorship, support, and committee hearing; all provisions related to and supporting ending the suffering of animals in US traveling acts, and to address the inherent health and safety risks such events pose to animals, workers, and the public. Support the following measures to the extent they protect animals from harm, end animal suffering, and promote conservation of wild populations (supporting ADI's overarching goal for longstanding change to end animal suffering and to promote conservation of wild populations): TEAPSPA (HR5999/ S3220); AFTER (Animal Freedom from Testing, Experiments, and Research) Act (HR5244); Alternatives to Animals for Regulatory Fairness (AARF) Act (HR1905); Animal Cruelty Enforcement Act HR1016; Animal Welfare Enforcement Improvement Act; Bear Poaching Elimination Act (S3472); Bear Protection Act (HR2325); Big Cat & Public Safety Act (HR263/ S1210); Break Free from Plastic Pollution Act (HR2238); Captive Primate Safety Act HR3135; Critically Endangered Animals Conservation Act (HR1569); Ejiao Act (HR5203); END Wildlife Trafficking Reauthorization Act; Federal fur action; FDA Modernization Act (HR2565/S2952); Food and Drug Amendments Act HR7667; Global Amphibian Protection Act (HR2026); HRes69 (National Biodiversity Strategy); Humane Cosmetics Act (HR6207/ S3357); Humane Research & Testing Act (HR1744); Kangaroo Protection Act HR917; Manatee Protection Act (HB4946); Minks in Narrowly Kept Spaces (MINKS) are Superspreaders Act (HR4310); Multinational Species Conservation Fund (HR6023); PAST (Preventing all soring tactics) Act (HR5441/ S2295); President Bidens Earth Day Executive Order; Preventing Future Pandemics Act (HR151/ S37/ S); Prohibit Wildlife Killing Contests Act HR7398; Reducing Waste in National Parks Act HR5533; Right Whale Coexistence Act (HR6785/ S3664); SAFE (Save Forgotten Equines) Act HR3355; SAVE North Atlantic Right Whales Act HR4487; Sea Turtle Rescue Assistance Grant Program; Shark Fin Sales Elimination Act (S1106); Tropical Forest and Coral Reef Conservation Reauthorization Act; Veterans for Mustangs Act HR7631; Wild Horse & Burro Protection Act HR6635. Opposing the following bills, which seek to reduce protections for animals, and/or their ecosystems and habitats: Armed Forces Endangered Species Exemption Act HR7197; HR7766; HR8136 Monitoring, taking a neutral or no position on, the following bills: Farm System Reform Act; Recovering Americas Wildlife Act (HR2773/ S2372).

Client expense: $8,019 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Council on Environmental Quality (CEQ), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Interior, Dept of (DOI), President of the U.S., SENATE, U.S. Agency for International Development (USAID), U.S. Fish & Wildlife Service (USFWS)

Healthcare issues related to clinical laboratories; H.R. 8188/S. 4449, the Saving Access to Laboratory Services Act (SALSA), provisions relating to reform of Medicare reimbursement for clinical laboratory services under Section 216 of the Protecting Access to Medicare Act, Pub. L. 113-93; H.R. 4128/S. 2209, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, included as Subtitle C of Title VIII of S. 4348, the FDA Safety and Landmark Advancements Act (FDASLA), provisions relating to FDA oversight of laboratory-developed tests; H.R. 6000, the Cures 2.0 Act, provisions relating to pandemic preparedness, improvements in clinical research processes, and advancement of genetic and genomic testing;H.R. 2565/S. 2952, the FDA Modernization Act, provisions relating to biomedical research; Federal policy related to implementation of the Families First Coronavirus Response Act, Pub. L. 116-127, provisions relating to coverage of and funding for COVID-19 diagnostic tests; Federal policy related to implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. 116-136, provisions relating to coverage and reimbursement of COVID-19 diagnostic tests and Medicare reimbursement for clinical laboratory tests; Federal policy relating to the National Correct Coding Initiative and manual instructions inconsistent with American Medical Association guidelines for Current Procedural Terminology (CPT) coding; and Federal policy relating to availability of Current Procedural Terminology (CPT) codes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.

Client expense: $740,000 · Firm income: Not reported

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

H.R. 2471 Consolidated Appropriations Act, FY2022 S.2076/H.R. 3932 PASTEUR Act H.R.7667 - Food and Drug Amendments of 2022 S.4348 - FDASLA Act of 2022 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act H.R.3085 - ENACT Act of 2021 -Issues related to public health protection including influenza development and preparedness -Issues related to antimicrobial and antiviral research and product development -Issues related to novel coronavirus and COVID-19 research and product development -Issues related to drug development including PDUFA and Cures 2.0

Client expense: $1,650,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2163/S. 464 - Safe Step Act S.1773 - Prescription Drug Pricing Dashboard Act H.R. 5376 - Build Back Better Act H.R. 3684- Infrastructure Investment and Jobs Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act S.2076/H.R. 3932 PASTEUR Act S. 3799- PREVENT Pandemics Act H.R.4521 - COMPETES Act of 2022 S.1260 - United States Innovation and Competition Act of 2021 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. -Issues related to healthcare legislation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to health equity, diversity, and inclusion in clinical trials -Issues related to advanced development and procurement of medical countermeasures (MCMs) -Issues related to patient assistance and access -Issues relating to privacy and securing the data of and personal information of consumers -Issues relating to medical research data -Issues relating to screening and diagnostics -Issues related to public health preparedness and response

Client expense: $1,650,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2163/S. 464 - Safe Step Act S.1773 - Prescription Drug Pricing Dashboard Act H.R. 5376 - Build Back Better Act H.R. 3684- Infrastructure Investment and Jobs Act H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act S.2076/H.R. 3932 PASTEUR Act S. 3799- PREVENT Pandemics Act H.R.4521 - COMPETES Act of 2022 S.1260 - United States Innovation and Competition Act of 2021 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. -Issues related to healthcare legislation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to health equity, diversity, and inclusion in clinical trials -Issues related to advanced development and procurement of medical countermeasures (MCMs) -Issues related to patient assistance and access -Issues relating to privacy and securing the data of and personal information of consumers -Issues relating to medical research data -Issues relating to screening and diagnostics -Issues related to public health preparedness and response

Client expense: $1,650,000 · Firm income: Not reported

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

- S. 2952, FDA Modernization Act of 2021 - S. 3472, Bear Poaching Elimination Act - S. 1210, Big Cat Public Safety Act - S. 4157, LEAD Act of 2022 - Legislation related to domestic mink farming - Legislation related to wild horses

Client expense: Not reported · Firm income: $30,000

Government targets: SENATE