Prescription Information Modernization Act of 2023

340B: Biologic/Small molecule drug negotiation eligibility within HR 7174/S. 832; EPIC Act; CDC Type 1 Diabetes Awareness and Education: LHHS approps; Clinical Trial Diversity; Copay Accumulators; COPD Education and Awareness: LHHS approps; COPD Research Funding: LHHS approps; Delinking; Drug Price Negotiations; Drug Pricing- General Issues; FDA Drug Development; FDA Issues - General; HR 946- Orphan Drug Negotiation: Orphan Cures Act; HR 1503: Prescription Information Modernization Act of 2023; HR 2880: Protecting Patients Against PBM Abuses Act; HR 5376: Inflation Reduction Act; HR 830: HELP Copays Act; HRSA - Type 1 Diabetes Screening: LHHS approps; Influenza Vaccines; Insulin Pricing-General; Insurance Design; Intellectual Property; Out of Pocket Cap (OOP); Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization; Pharmacy Benefit Managers (PBM) Reform; Rare Pediatric Priority Review Voucher Program Reauthorization within HR 1262/ S. 932: Give Kids a Chance Act; Rebate Pass Through; Respiratory Syncytial Virus (RSV) Access; Routine Immunization Rates; S. 1339: PBM Reform Act; S. 864: HELP Copays Act; S. 1542: DRUG Act; S. 2916: Prescription Information Modernization Act of 2023; S.4504 / HR 8698 (118th): SCREEN for Type 1 Diabetes Act; Supply Chain; Tax Credits; Transplant; Type 1 Diabetes Screening; Vaccine Injury Compensation Program; Vaccines-General Issues.

Client expense: $2,540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1244, Reducing Drug Prices for Seniors Act H.R. 1492, To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program. H.R. 1503/S. 2916, Prescription Information Modernization Act of 2023 H.R. 1968, Full-Year Continuing Appropriations and Extensions Act, 2025 S. 1040, Drug Competition Enhancement Act S. 1339, Pharmacy Benefit Manager Reform Act S. 2076 Pioneering Antimicrobial Subscriptions To End Up surging Resistance (PASTEUR) Act of 2021 Issues relating to, 340B program integrity; 340B of the Public Health Services Act; 340B issues; 340B drug pricing program; Drug pricing; Drug pricing and reimbursement issues; Prescription drug cost-sharing; Anti-microbial Resistance; Cost and value of medicines; Respiratory Syncytial Virus (RSV) immunization; Vaccines issues; Vaccine misinformation; Measles, Mumps, and Rubella (MMR) immunizations; Package inserts, labeling issues, and E-Labeling authorization legislation; Pharmaceutical supply channel issues; Drug shortage issues; Inflation Reduction Act (P.L. 117-169), issues relating to drug pricing provisions; FY-2025 Budget and Appropriations Legislation; Intellectual property protection and trade issues; WTO IP Waiver for COVID therapeutics; Animal Health; Animal Health Technology Issues; Animal Health Policy Issues: Animal Drug User Fee Act (ADUFA) & Funding for Electronic Animal Traceability; One Health Issues; General pharmaceutical issues; Vaccine Injury Compensation Program (VICP); Diversity in clinical trials; Accelerated approval reform; Pharmacy Benefit Manager (PBM) policy issues; Pharmacy Benefit Manager reforms; Food and Drug Administration issues; Public Health Issues.

Client expense: $2,600,000 · Firm income: Not reported

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.

Client expense: $530,000 · Firm income: Not reported

Issues related to prescription-to- over the counter switch; issues related to influenza vaccines; issues related to 340B; issues related to Respiratory Syncytial Virus (RSV) access; general issues related to vaccines; issues related to clinical trial diversity; general issues related to drug pricing; issues related to out of pocket (OOP); general issues to insulin pricing; issues related to Additional Condition for Prescription Use (ACNU); issues related to copay accumulators; issues related to HR3656 "Vaccine Access Improvement Act"; issues related to Vaccine Issues Compensation Program (VICP); issues related to HR 830 "HELP Copays Act"; issues related to Pandemic and All-Hazards Preparedness Act (PAHPA)reauthorization; issues related to HR 1503 "Prescription Information Modernization Act of 2023"; general issues related FDA; issues related to FDA Drug Development; issues related to Pharmacy Benefit Managers (PBMs); issues related to insurance design; issues related to S. 1542 "DRUG Act"; issues related to S. 1375 "HELP Copays Act"; issues related to tax credits; issues related to S. 1339 "PBM Reform Act"; issues related to delinking; issues related to HR 2880 "Protecting Patients Against PBM Abuse Act"; issues related to Type 1 Diabetes screening; issues related to intellectual property; issues related to Transplant; issues related HR 5339 and S. 3131 "Orphan Cures Act"; Rare Pediatric Priority Review Voucher Program related to HR 7834 "Creating Hope Reauthorization Act of 2024"; Orphan Drug Negotiation within HR5378 "Inflation Reduction Act"; issues related to drug price negotiations; issues related to COPD Research funding; Biologic/Small Molecule drug negotiation eligibility within HR7174 "EPIC Act"; CDC Type 1 Diabetes Awareness and Education with LHHS appropriations; issues related to S.4504 "SCREEN for Type 1 Diabetes"; issues related to HRSA - Type 1 Diabetes Screening in LHHS Appropriations; general issues related to Inflation Reduction Act; issues related to Routine Immunizations Rates; issues related to HR5376 "Inflation Reduction Act"; issues related to Rebate Pass Through; and issues related to S. 2916 "Prescription Information Modernization Act of 2023";

HR 1503/S 2916 Prescription Information Modernization Act Amending Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169 e-labeling - allowing FDA to finalize a rule to allow digital versions of prescriptions Medicare patient access to rare disease therapies, Part B and Part D drugs Centers for Medicare and Medicaid Innovation (CMMI) policy issues Medicare drug price negotiation Medicare Part D reform and inflation penalties Medicaid Drug Rebate Program proposed rule Value-based payment arrangements Efforts to improve coding, coverage, and access for rare disease therapies Medicaid Drug Rebate Program proposed rule, specifically the stacking rule General issues related to diagnostic reimbursement

Client expense: $640,000 · Firm income: Not reported

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S.2510/H.R.6802). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY2025 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution. Seniors Access to Critical Medications Act of 2023 (H.R. 5526/S.3458) Department of Defense Essential Medicines Strategic Stockpile Amendment to NDAA Health Care Cybersecurity Improvement Act of 2024 (S.4054) Broadening Utilization of Proven and Effective Treatment for Recovery Act or the BUPE for Recovery Act (H.R.9886/S.5271)

Client expense: $1,100,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Science & Technology Policy (OSTP), SENATE, White House Office

Addressing drug shortages and enhancing domestic production of critical medicines Issues related to biosimilars Promoting long-term sustainability of access for patients to generic and biosimilar medicines H.R.1503/S.2916: Prescription Information Modernization Act of 2023 H.R.2880: Protecting Patients Against PBM Abuses Act H.R.5429/S.2780: Medication Affordability and Patent Integrity Act 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024 Lower Costs, More Transparency Act (H.R. 5378) H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act S.2305: Biosimilar Red Tape Elimination Act Appropriations pertaining to American Made preference for generic products Issues related to Medicaid Generics Penalty Issues related to the IRA Issues related to drug supply chain Senate Finance Committee drug shortage legislation Proposals related to drug shortages Issues related to Levothyroxine.

Client expense: $210,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Addressing drug shortages and enhancing domestic production of critical medicines Issues related to biosimilars Promoting long-term sustainability of access for patients to generic and biosimilar medicines H.R.1503/S.2916: Prescription Information Modernization Act of 2023 H.R.2880: Protecting Patients Against PBM Abuses Act H.R.5429/S.2780: Medication Affordability and Patent Integrity Act 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024 Lower Costs, More Transparency Act (H.R. 5378) H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act S.2305: Biosimilar Red Tape Elimination Act Appropriations pertaining to American Made preference for generic products Issues related to Medicaid Generics Penalty Issues related to the IRA Issues related to drug supply chain Senate Finance Committee drug shortage legislation Proposals related to drug shortages

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Generally promoting awareness of the biopharmaceutical and medical technology sectors. Generally opposing the imposition of price controls in the Medicare Part D program or elsewhere. Generally supporting intellectual property rights. Generally opposing various legislative and executive efforts to impose an international price index. Generally promoting awareness of increasing antimicrobial/antifungal resistance. Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting the extension of the SBIR program. Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Opposing proposed FTC changes to non-compete clauses. Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET (H.R. 1691). Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Supporting the Saving Access to Laboratory Services (SALSA) Act (H.R. 2377). Supporting the Protecting Patients Against PBM Abuses Act (H.R. 2880). Supporting the PASTEUR Act (H.R. 2940 and S. 1355). Supporting the Treat And Reduce Obesity Act (H.R. 4818, S. 2407). Supporting the Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 5391 and S. 2764). Supporting the ORPHAN CURES Act (H.R. 5539). Supporting the Maintaining Investments in New Innovation (MINI) Act (H.R. 5547). Supporting the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283). Supporting changes to the small molecule portions of the Inflation Reduction Act (H.R. 7174). Supporting "cap and smooth" efforts within the Inflation Reduction Act's cap on out-of-pocket expenses. Supporting CMS proposed rule, CMS-1809-P, to include separate payment for diagnostic radiopharmaceuticals in CY2025.

VICP Reform and Excise Tax Inflation Reduction Act (IRA) HR7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Part D Payer Utilization Management Drug Shortages S2916 - Prescription Information Modernization Act of 2023 Vaccines, Clinical Trials and Coverage S2305 - Biosimilar Red Tape Elimination Act Biosimilar Access and Interchangeability HR 2666 - Medicaid Value Based Payments for Patients (MVP) Act HR 4758 - Accelerating Kids Access to Care Act HR 7384 - Rare Pediatric Disease Priority Review (PRV) Voucher Trade-Related Aspects of Intellectual Property Rights March-in Framework Guidance and Policies S.79 - Interagency Patent Coordination and Improvement Act of 2023 S.142 - Preserve Access to Affordable Generics and Biosimilars Act S.150 - Affordable Prescriptions for Patients Act of 2023 S.2780 - Medication Affordability and Patent Integrity Act Digital: Data Flows and Digital Trade

Client expense: $1,070,000 · Firm income: Not reported

Addressing drug shortages and enhancing domestic production of critical medicines Issues related to biosimilars Promoting long-term sustainability of access for patients to generic and biosimilar medicines H.R.1503/S.2916: Prescription Information Modernization Act of 2023 H.R.2880: Protecting Patients Against PBM Abuses Act H.R.5429/S.2780: Medication Affordability and Patent Integrity Act 117 - S.2082 - Manufacturing API, Drugs, and Excipients (MADE) in America Act S.3311 - American Made Pharmaceuticals Act of 2023 Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024 Lower Costs, More Transparency Act (H.R. 5378) H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act S.2305: Biosimilar Red Tape Elimination Act Appropriations pertaining to American Made preference for generic products Issues related to Medicaid Generics Penalty Issues related to the IRA Issues related to drug supply chain Senate Finance Committee drug shortage legislation Proposals related to drug shortages

Client expense: $170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Amending Orphan drug exemption of the Implementation of the Inflation Reduction Act, Pub L 117-169; Issues related to implementation of H.R.5376 - Inflation Reduction Act of 2022 (Public Law No 117-169); e-labeling - allowing FDA to finalize a rule to allow digital versions of prescriptions; Value-based payment arrangements; CMMI; CMS Comment Solicitation on Possible Mechanisms to Address Rare Diseases and Conditions Represented by Low Volumes within the MS-DRG Structure; Efforts to improve coding, coverage, and access for rare disease therapies; Medicaid Drug Rebate Program proposed rule, specifically the stacking rule; Medicare patient access to rare disease therapies, Part B and Part D drugs; Centers for Medicare and Medicaid Innovation (CMMI) policy issues; Center for Medicare and Medicaid Innovation models; General issues related to diagnostic reimbursement; H.R. 5539/S. 3131 Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act; HR1503/S2916 Prescription Information Modernization Act; H.R. 3876 Access to Genetic Counselor Services Act of 2023; H.R. 2666 Medicaid VBPs for Patients Act.

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

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Ensuring essential medication supply for military and Department of Defense. Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S.2510/H.R.6802). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY2025 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution. Seniors Access to Critical Medications Act of 2023 (H.R. 5526/S.3458) Department of Defense Essential Medicines Strategic Stockpile Amendment to NDAA Health Care Cybersecurity Improvement Act of 2024 (S.4054) Drug Supply Chain Security Act (DSCSA)

Client expense: $570,000 · Firm income: Not reported

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

VICP Reform and Excise Tax Inflation Reduction Act (IRA) HR7174 - Ensuring Pathways to Innovative Cures (EPIC) Act Medicare Price Setting Part D Payer Utilization Management Drug Shortages S2916 - Prescription Information Modernization Act of 2023 Vaccines, Clinical Trials and Coverage S2305 - Biosimilar Red Tape Elimination Act Biosimilar Access and Interchangeability HR 2666 - Medicaid Value Based Payments for Patients (MVP) Act HR 4758 - Accelerating Kids Access to Care Act HR 7384 - Rare Pediatric Disease Priority Review (PRV) Voucher Trade-Related Aspects of Intellectual Property Rights March-in Framework Guidance and Policies S.79 - Interagency Patent Coordination and Improvement Act of 2023 S.142 - Preserve Access to Affordable Generics and Biosimilars Act S.150 - Affordable Prescriptions for Patients Act of 2023 S.2780 - Medication Affordability and Patent Integrity Act Digital: Data Flows and Digital Trade

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

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. S.1961: Pharmaceutical Supply Chain Risk Assessment Act of 2023. H.R.6109: Producing Incentives for Long-term Production of Lifesaving Supply of Medicines (PILLS) Act. Drug Shortages. S.2362 - Drug Shortage Prevention Act. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.

Client expense: $530,000 · Firm income: Not reported

Generally promoting awareness of the biopharmaceutical and medical technology sectors. Generally opposing the imposition of price controls in the Medicare Part D program or elsewhere. Generally supporting intellectual property rights. Generally opposing various legislative and executive efforts to impose an international price index. Generally promoting awareness of increasing antimicrobial/antifungal resistance. Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting the extension of the SBIR program. Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Opposing proposed FTC changes to non-compete clauses. Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET (H.R. 1691). Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Supporting the Saving Access to Laboratory Services (SALSA) Act (H.R. 2377). Supporting the Protecting Patients Against PBM Abuses Act (H.R. 2880). Supporting the PASTEUR Act (H.R. 2940 and S. 1355). Supporting the Treat And Reduce Obesity Act (H.R. 4818, S. 2407). Supporting the Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 5391 and S. 2764). Supporting the ORPHAN CURES Act (H.R. 5539). Supporting the Maintaining Investments in New Innovation (MINI) Act (H.R. 5547). Supporting the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283). Supporting changes to the small molecule portions of the Inflation Reduction Act (H.R. 7174). Supporting "cap and smooth" efforts within the Inflation Reduction Act's cap on out-of-pocket expenses. Supporting CMS proposed rule, CMS-1809-P, to include separate payment for diagnostic radiopharmaceuticals in CY2025.

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Ensuring essential medication supply for military and Department of Defense. Digital communication of prescribing information. Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S.2510/H.R.6802). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY2025 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution. Seniors Access to Critical Medications Act of 2023 (H.R. 5526) Department of Defense Essential Medicines Strategic Stockpile Amendment to NDAA Health Care Cybersecurity Improvement Act of 2024 (S.4054)

Client expense: $440,000 · Firm income: Not reported

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

IP Issues: Trade-Related Aspects of Intellectual Property Rights March-in Framework Guidance and Policies Digital: S2916 - Digital Communication of Prescribing Information for Drugs

Client expense: $2,450,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Generic Drug Procurement Language as it Relates to H.R.2670/S.2226 - National Defense Authorization Act for Fiscal Year 2024. Drug Shortages. Biosimilar Exclusivity. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Drug-Device Combination Products. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.

Client expense: $580,000 · Firm income: Not reported

Generally promoting awareness of the biopharmaceutical and medical technology sectors. Generally opposing the imposition of price controls in the Medicare Part D program or elsewhere. Generally supporting intellectual property rights. Generally opposing various legislative and executive efforts to impose an international price index. Generally promoting awareness of increasing antimicrobial/antifungal resistance. Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting the extension of the SBIR program. Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Opposing proposed FTC changes to non-compete clauses. Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET (H.R. 1691). Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Supporting the Saving Access to Laboratory Services (SALSA) Act (H.R. 2377). Supporting the Protecting Patients Against PBM Abuses Act (H.R. 2880). Supporting the PASTEUR Act (H.R. 2940 and S. 1355). Supporting the Treat And Reduce Obesity Act (H.R. 4818, S. 2407). Supporting the Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 5391 and S. 2764). Supporting the ORPHAN CURES Act (H.R. 5539). Supporting the Maintaining Investments in New Innovation (MINI) Act (H.R. 5547). Supporting the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283). Supporting changes to the small molecule portions of the Inflation Reduction Act (H.R. 7174).

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Ensuring essential medication supply for military and Department of Defense. Digital communication of prescribing information. Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages. Block, Report and Suspend Suspicious Shipments Act (H.R.501). Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S.2510/H.R.6802). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY2024 National Defense Authorization Act. FY2025 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution.

Client expense: $1,190,000 · Firm income: Not reported

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

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. Drug Shortages. S.2305: Biosimilar Red Tape Elimination Act. FDA Inspections. Third Party Drug Quality Studies. H.R.3561: PATIENT Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act. DEA Quotas.

Client expense: $510,000 · Firm income: Not reported

Generally promoting awareness of the biopharmaceutical and medical technology sectors. Generally opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Generally opposing various legislative and executive efforts to impose an international price index. Generally promoting awareness of increasing antimicrobial/antifungal resistance. Supporting the PASTEUR Act S. 1355 and H.R. 2940. Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET (H.R. 1691). Opposing WHO TRIPS waivers. Supporting the extension of the SBIR program. Supporting changes to the small molecule portions of the Inflation Reduction Act (H.R. 7174). Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Opposing proposed FTC changes to non-compete clauses. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Supporting the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283). Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Submitted comments to CMS concerning Transitional Coverage for Emerging Technologies (TCET) pathway. Opposing the SMART Act (S. 1246). Supporting the ORPHAN CURES Act (H.R. 5539). Supporting the Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 5391/S. 2764). Supporting the Treat And Reduce Obesity Act (H.R. 4818, S. 2407).

Strategic National Stockpile. Essential Medicines Strategic Stockpile Act (H.R.405). Ensuring essential medication supply for military and Department of Defense. Digital communication of prescribing information. Prescription Information Modernization Act (H.R.1503/S.2916). Drug Shortages. Block, Report and Suspend Suspicious Shipments Act (H.R.501). Pandemic and All Hazards Preparedness Reauthorization and Response Act (legislation). Drug Supply Chain Security Act Implementation (DSCSA). Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act (S. 2510). SUPPORT Act Reauthorization (S.2433/H.R.4531). FY 2024 National Defense Authorization Act. House E&C Drug Shortages Discussion Draft. FY 2024 Continuing Resolution.

Client expense: $510,000 · Firm income: Not reported

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

Prescription Drug Costs. H.R.5429/S.2780: Medication Affordability and Patent Integrity Act. 180-Day Exclusivity. S.1114: Expanding Access to Low-Cost Generics Act of 2023. H.R.5461/S.2129: Ensuring Access to Lower-Cost Medicines for Seniors Act. Labeling of Generic Drugs and Biosimilars. H.R.4134/S.2886: Updated Drug Labeling for Patient Safety Act. Hickenlooper Safe Harbor for Skinny Labeling. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. H.R.3839/S.775: Increasing Transparency in Generic Drug Applications Act. S.2510: RAPID Reserve Act. Drug Shortages. Stop Drug Shortages Act of 2023. H.R.405: Essential Medicines Strategic Stockpile Act of 2023. S.2305: Biosimilar Red Tape Eliminations Act. FDA Inspections. Process issues regarding third-party contract to assess drug quality. Inflation Reduction Act (IRA) Implementation. H.R.3561: PATIENT Act of 2023. H.R.3793: Ensuring Access to Lifesaving Drugs Act of 2023. H.R.1503/S.2916: Prescription Information Modernization Act of 2023. H.R.2880: Protecting Patients Against PBM Abuses Act.

Client expense: $610,000 · Firm income: Not reported

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Opposing various legislative and executive efforts to impose an international price index. Promoting awareness of increasing antimicrobial/antifungal resistance. Supporting the PASTEUR Act S. 1355 and H.R. 2940. Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET. Opposing WHO TRIPS waivers. Supporting the extension of the SBIR program. Supporting the Saving Access to Laboratory Services (SALSA) Act (H.R. 2377 and S. 1000). Supporting changes to the small molecule portions of the Inflation Reduction Act. Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Opposing proposed FTC changes to non-compete clauses. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Submitted comments to the EPA with respect to their proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Commercial Sterilization Facilities source category with respect to Ethylene Oxide, and EPAs Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Submitted comments to the FDA's Center for Drug Evaluation and Researchs (CDER) Discussion Paper regarding the use of Artificial Intelligence in Drug Manufacturing. Submitted comments to CMS concerning Transitional Coverage for Emerging Technologies (TCET) pathway. Opposing the SMART Act (S. 1246). Supporting the ORPHAN CURES Act (H.R. 5539). Supporting the Protecting Patient Access to Cancer and Complex Therapies Act (H.R. 5391/S. 2764). Supporting the Delinking Revenue from Unfair Gouging (DRUG) Act (H.R. 6283).

Promoting awareness of the biopharmaceutical and medical technology sectors. Opposing the imposition of price controls in the Medicare Part D program. Generally supporting intellectual property rights. Opposing various legislative and executive efforts to impose an international price index. Promoting awareness of increasing antimicrobial/antifungal resistance. Supporting the PASTEUR Act S. 1355 and H.R. 2940. Supporting the modernization of prescribing information to allow digital in lieu of printed information (H.R. 1503 and S. 2916). Opposing CMS and CMMI Part D Payment Modernization Model amendments to Medicare's Six Protected Classes. Supporting Ensuring Patient Access to Critical Breakthrough Products Act/MCET. Opposing TRIPS waivers. Supporting the extension of the SBIR program. Supporting the Saving Access to Laboratory Services (SALSA) Act (H.R. 2377 and S. 1000). Supporting changes to the small molecule portions of the Inflation Reduction Act. Supporting the Verifying Accurate Leading-edge IVCT Development (VALID) Act (H.R. 2369). Opposing proposed FTC changes to non-compete clauses. Supporting the restoration of the orphan drug tax credit (Cameron's Law, H.R. 1350). Generally supporting changes to the 340B program. Generally supporting efforts to require pharmacy benefit managers (PBMs) to pass on rebates to patients. Generally promoting awareness of concerns regarding the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) and Coverage with Evidence Development (CED) policies that restrict patient access. Raising awareness within Congressional offices about Ethylene Oxide and EPA proposed regulations. Submitted comments to the EPA with respect to their proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Commercial Sterilization Facilities source category with respect to Ethylene Oxide, and EPAs Proposed Interim Decision and Draft Risk Assessment Addendum for Ethylene Oxide pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Submitted comments to the FDA's Center for Drug Evaluation and Researchs (CDER) Discussion Paper regarding the use of Artificial Intelligence in Drug Manufacturing. Submitted comments to CMS concerning Transitional Coverage for Emerging Technologies (TCET) pathway. Opposing the SMART Act (S. 1246).