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vs 5,357 other S bills in the 117th — cohort avg 38d
Retaining Access and Restoring Exclusivity Act or the RARE Act This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition. Current law grants a seven-year period of market exclusivity for an approved orphan drug, during which the Food and Drug Administration (FDA) may not approve an application from another manufacturer for the same drug for the same disease or condition. The FDA's regulations provide that this exclusivity is specific to the same approved use or indication of the drug, rather than all uses or indications, for the disease or condition. However, in Catalyst Pharmaceuticals, Inc. v. Becerra, a court held that exclusivity did extend to all uses or indications for the disease or condition. The bill provides statutory authority for the FDA's regulations.
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Filing registrants (5)
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Advocated in favor of robust appropriations funding for the National Institutes of Health, the Food and Drug Administration, the Health Resources and Services Administration, and the Centers for Disease Control and Prevention. Advocated for greater appropriations for the National Center for Advancing Translational Sciences (NCATS) Advocated for greater appropriations for the National Institutes of Health. Advocated for appropriations for HHS, NIH, and FDA to implement the ACT for ALS. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the end-of-year omnibus legislation. Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Advocated for the passage of the RARE Act (S. 4185) as part of the Senate FDA User Fee process. Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Advocated for passage of FDA and clinical trial reforms within an end-of-year bill, including accelerated approval reforms, clinical trial diversity advancements, the RARE Act, reauthorization of the Orphan Product Grants Program, and more.
Client expense: $220,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2022 · fourth_quarter · Health Issues
Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for robust funding of the national newborn screening program. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, Centers for Disease Control and Prevention, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Advocated for the swift funding and implementation of the ACT for ALS Act (S.1813 and H.R.3537). Advocated for access to healthcare via telemedicine/telehealth throughout and after the COVID-19 public health emergency. Advocated for increased funding of home and community-based services (HCBS). Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the end-of-year omnibus package. Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Supported greater appropriations for Consumer Assistance Programs Advocated for the passage of the RARE Act (S. 4185) as part of the end-of-year omnibus package. Supported passage of the Ending the Diagnostic Odyssey Act Advocated for the passage of the Accelerating Kids Access to Care Act Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Support the passage of the Precision Medicine for Children Act Advocated for the passage of the HCBS Access Act Supported the passage of the Stop the Wait Act (S. 3575 / H.R. 6583) Advocated for the Access to Genetic Counselors Act Provided recommendations to the Department of Health and Human Services on the implementation of section 1557 of the Affordable Care Act. Applauded the Department of Health and Human Services in their closing of the family glitch within the Affordable Care Act. Advocated to the Centers for Medicare and Medicaid Services on Medicaid access and the COVID-19 public health emergency Called for passage of the Preserving Patient Access to Home Infusion Act (S. 2652/H.R. 5067) Provided comments to CMS on ensuring equity in accessing health care. Provided comments to the Department of Health and Human Services on how best to streamline eligibility and enrollment within the Medicaid and CHIP programs. Called for recipients of the Deferred Action for Childhood Arrivals program to access Federal health programs and offerings. Provided comments to the CMS on the implementation of the No Surprises Act. Called for greater funding of the National Center for Advancing Translational Sciences (NCATS) Called for the passage of the Medicare Orthotic & Prosthetic Patient-Centered Care Act Provided comments to CMS on National Directory of Healthcare Providers and Services
Client expense: $220,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Council on Disability, Natl Institutes of Health (NIH), SENATE, Treasury, Dept of
2022 · fourth_quarter · Health Issues
Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act, HR 5376 - extension of expanded tax credits for ACA marketplaces; HR 1550, The Prevent HPV Cancers Act S. 699, Women and Lung Cancer Research and Preventive Services Act of 2021 HR 623, Gabriella Miller Kids First Research Act 2.0 S. 4260, The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act, S 2890 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Suprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act of 2021 - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act - Feinstein, Collins H.R. 6638 - Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act - DeGette, Bennet, Burr, Buschon DIVERSE Trials Act - H.R.5030/ S.2706 DEPICT Act, HR 6584 Give Kids a Chance Act, H.R. 6972 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348 S. 4185, the Retaining Access and Restoring Exclusivity (RARE) Act Potential legislation on cancer survivorship being developed by Rep. Wasserman Schultz Health Equity and Accountability Act, HR 7585 Notice of Benefit and Payment Parameters, regulatory comments Regulatory issues related to healthy food and dietary guidelines
Client expense: $1,990,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office
2022 · fourth_quarter · Health Issues
HR 2617, the Consolidated Appropriations Act 2023; , HR 4385 / S 3080, the Cancer Drug Parity Act; HR 5030 / S 2706, the Diverse Trials Act; HR 7630 / 4120, Childhood Cancer STAR Reauthorization Act; HR 5416, the Give Kids a Chance Act; HR 6584, the DEPICT Act; HR 7512, the Protecting Patients from Deceptive Health Plans Act; HR 7667, the Food and Drug Amendments Act; specifically Title V; HR 8845, the NIH Clinical Trial Diversity Act; HR 8324, the Health Share Transparency Act; S 4185, the RARE Act; S 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act; S 4294, Pharmacy Benefit Manager Transparency Act of 2022; FDA regulations regarding sites of delivery for clinical trial services; federal regulation of Short Term Limited Duration Insurance and other non-ACA compliant insurance plans; implementation of the No Surprises Act (enacted in the 116th Congress); Consumer Assistance Programs; 2024 Notice of Benefit and Payment Parameters regulation
Client expense: $140,000 · 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), SENATE
2022 · fourth_quarter · Health Issues
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---S.4351/H.R. 6973: Enhanced Access to Affordable Medicines Act ---S.4338/H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Rare Pediatric Disease Priority Review ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4509 Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
Client expense: $3,740,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
2022 · fourth_quarter · Taxation/Internal Revenue Code
Biofuels (Non-Funding) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.3448: Helping Startups Continue to Grow Act ---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities (Discussion Draft) ---A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. (Discussion Draft) ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---Reform of New Operating Loss Rules Coronavirus (COVID-19) Pandemic ---Temporarily Refundable R&D Credit Orphan Drug Issues ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Tax Credit Qualified Small Business Stock (QSBS) ---Draft Legislation to modify and expand the Section 1202 exclusion for gain from QSBS ---Implementation of the Inflation Reduction Act (IRA) of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit Research & Development Tax Credit Reforms ---H.R.1304/S.749: American Innovation and Jobs Act ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft) ---Expensing of R&D Expenditures ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Incentives for Sustainable Aviation Fuels ---R&D Payroll Credit Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)
H.R. 1992, SCALE Act, Storing CO2 and Lowering Emissions Act; S. 799, SCALE Act, Storing CO2 and Lowering Emissions Act; Nationwide Permits (no specific bills); H.R. 4084, Methane Emissions Reductions Act; S. 645, Methane Emissions Reductions Act of 2021; HR 5376, Build Back Better; HR 6084, Energy Product Reliability Act; FERC Draft Policy Statements; Nationwide Permit 12 and NEPA revisions (no specific bills).Pipeline Permitting Reform legislation (no specific bills); S. 4185, START ACT; Pipeline Safety Reauthorization (no specific bills).
Client expense: $70,000 · Firm income: Not reported
Government targets: Army, Dept of (Corps of Engineers), Council on Environmental Quality (CEQ), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2022 · third_quarter · Health Issues
Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for robust funding of the national newborn screening program. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, Centers for Disease Control and Prevention, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Advocated for the swift funding and implementation of the ACT for ALS Act (S.1813 and H.R.3537). Advocated for access to healthcare via telemedicine/telehealth throughout and after the COVID-19 public health emergency. Advocated for closure of the Medicaid coverage gap and the permanence of the Advanced Premium Tax Credits as part of the Build Back Better Act. Advocated for a robust paid medical leave program. Advocated for increased funding of home and community-based services (HCBS). Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the FDA user fee reauthorizations Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Supported greater appropriations for Consumer Assistance Programs Advocated for the passage of the RARE Act (S. 4185) as part of the Senate FDA User Fee process. Commented on fixing the ACA Family Glitch to the Treasury Department Supported reforms to the HCPCS coding system. Supported passage of the Ending the Diagnostic Odyssey Act Advocated for the passage of the Accelerating Kids Access to Care Act Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Support the passage of the Precision Medicine for Children Act Advocated for the passage of the HCBS Access Act Supported the passage of the Stop the Wait Act (S. 3575 / H.R. 6583) Provided comments to Congress on portions of the Inflation Reduction Act, including the Medicare out-of-pocket cap and smoothing mechanisms. Joined coalition comments on the CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies Proposed Rule. Provided policy suggestions to CMS on the annual Notice of Benefit and Payment Parameters. Advocated for greater coverage of seat elevation systems and standing wheelchairs within the Medicare program. Advocated for the Access to Genetic Counselors Act
2022 · third_quarter · Medical/Disease Research/Clinical Labs
Advocated in favor of robust appropriations funding for the National Institutes of Health, the Food and Drug Administration, the Health Resources and Services Administration, and the Centers for Disease Control and Prevention. Advocated for greater appropriations for the National Center for Advancing Translational Sciences (NCATS) Advocated for greater appropriations for the National Institutes of Health. Advocated for appropriations for HHS, NIH, and FDA to implement the ACT for ALS. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the FDA user fee reauthorizations Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Advocated for the passage of the RARE Act (S. 4185) as part of the Senate FDA User Fee process. Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Advocated for passage of FDA and clinical trial reforms within an end-of-year bill, including accelerated approval reforms, clinical trial diversity advancements, the RARE Act, reauthorization of the Orphan Product Grants Program, and more.
Client expense: $200,000 · Firm income: Not reported
2022 · third_quarter · Health Issues
Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act, HR 5376 - extension of expanded tax credits for ACA marketplaces; HR 1550, The Prevent HPV Cancers Act S. 699, Women and Lung Cancer Research and Preventive Services Act of 2021 HR 623, Gabriella Miller Kids First Research Act 2.0 S. 4260, The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act, S 2890 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Suprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act of 2021 - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act - Feinstein, Collins H.R. 6638 - Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act - DeGette, Bennet, Burr, Buschon DIVERSE Trials Act - H.R.5030/ S.2706 DEPICT Act, HR 6584 Give Kids a Chance Act, H.R. 6972 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348 S. 4185, the Retaining Access and Restoring Exclusivity (RARE) Act Potential legislation on cancer survivorship being developed by Rep. Wasserman Schultz Health Equity and Accountability Act, HR 7585 Notice of Benefit and Payment Parameters, regulatory comments Regulatory issues related to healthy food and dietary guidelines
2022 · third_quarter · Health Issues
Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Inflation Reduction Act, HR 5376 - extension of expanded tax credits for ACA marketplaces; HR 1550, The Prevent HPV Cancers Act S. 699, Women and Lung Cancer Research and Preventive Services Act of 2021 HR 623, Gabriella Miller Kids First Research Act 2.0 S. 4260, The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act, S 2890 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Suprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans (upcoming) OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act of 2021 - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act - Feinstein, Collins H.R. 6638 - Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act - DeGette, Bennet, Burr, Buschon DIVERSE Trials Act - H.R.5030/ S.2706 DEPICT Act, HR 6584 Give Kids a Chance Act, H.R. 6972 NIH Clinical Trials Diversity Act, HR 7845 HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348 S. 4185, the Retaining Access and Restoring Exclusivity (RARE) Act Potential legislation on cancer survivorship being developed by Rep. Wasserman Schultz Health Equity and Accountability Act, HR 7585 Notice of Benefit and Payment Parameters, regulatory comments Regulatory issues related to healthy food and dietary guidelines
2022 · third_quarter · Health Issues
HR 5776, the Build Back Better Act; HR 4385 / S 3080, the Cancer Drug Parity Act; HR 5030 / S 2706, the Diverse Trials Act; HR 7630 / 4120, Childhood Cancer STAR Reauthorization Act; HR 5416, the Give Kids a Chance Act; HR 6584, the DEPICT Act; HR 7512, the Protecting Patients from Deceptive Health Plans Act; HR 7667, the Food and Drug Amendments Act; specifically Title V; HR 8845, the NIH Clinical Trial Diversity Act; HR 8324, the Health Share Transparency Act; S 4185, the RARE Act; S 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act; S 4294, Pharmacy Benefit Manager Transparency Act of 2022; HR 6833, the FY2023 Continuing Appropriations and Ukraine Supplemental Appropriations Act, specifically provisions related to FDA user fees; FDA regulations regarding sites of delivery for clinical trial services; federal regulation of Short Term Limited Duration Insurance and other non-ACA compliant insurance plans; implementation of the No Surprises Act (enacted in the 116th Congress); Consumer Assistance Programs; 2024 Notice of Benefit and Payment Parameters regulation
Client expense: $120,000 · Firm income: Not reported
H.R. 1992, SCALE Act, Storing CO2 and Lowering Emissions Act; S. 799, SCALE Act, Storing CO2 and Lowering Emissions Act; Nationwide Permits (no specific bills); H.R. 4084, Methane Emissions Reductions Act; S. 645, Methane Emissions Reductions Act of 2021; HR 5376, Build Back Better; HR 6084, Energy Product Reliability Act; FERC Draft Policy Statements; Nationwide Permit 12 and NEPA revisions (no specific bills).Pipeline Permitting Reform legislation (no specific bills); S. 4185, START ACT.
Client expense: $70,000 · Firm income: Not reported
Government targets: Army, Dept of (Corps of Engineers), Council on Environmental Quality (CEQ), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
2022 · third_quarter · Health Issues
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities --- In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment (Discussion Draft) ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2023 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Continuing Resolution ---FY 2023 Appropriations Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.5566 Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)
2022 · third_quarter · Taxation/Internal Revenue Code
Biofuels (Non-Funding) ---H.R.5376: Inflation Reduction Act of 2022 ---Sustainable Aviation Fuels Tax Credit Capital Formation Incentives ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.3448: Helping Startups Continue to Grow Act --- H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7515: Infectious Disease Therapies Research and Innovation Act of 2022 ---A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities (Discussion Draft) ---A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. (Discussion Draft) ---Reform of New Operating Loss Rules Coronavirus (COVID-19) Pandemic ---Temporarily Refundable R&D Credit Orphan Drug Issues ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Tax Credit Qualified Small Business Stock (QSBS) ---H.R.5376: Inflation Reduction Act of 2022 Renewable Chemicals/Bio-based Products (Non-Funding) ---Investment Tax Credit ---Production Tax Credit Research & Development Tax Credit Reforms ---H.R.1304/S.749: American Innovation and Jobs Act ---H.R.5376: Inflation Reduction Act of 2022 ---Expensing of R&D Expenditures Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)
Client expense: $3,220,000 · Firm income: Not reported
2022 · second_quarter · Medical/Disease Research/Clinical Labs
Advocated in favor of robust appropriations funding for the National Institutes of Health, the Food and Drug Administration, the Health Resources and Services Administration, and the Centers for Disease Control and Prevention. Advocated for greater appropriations for the National Center for Advancing Translational Sciences (NCATS) Advocated for greater appropriations for the National Institutes of Health. Advocated for appropriations for HHS, NIH, and FDA to implement the ACT for ALS. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the FDA user fee reauthorizations Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Advocated for the passage of the RARE Act (S. 4185) as part of the Senate FDA User Fee process. Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000)
Client expense: $200,000 · Firm income: Not reported
2022 · second_quarter · Health Issues
Health care issues affecting individuals with neuromuscular disease including therapy development, newborn screening, screening and diagnosis, adequate insurance coverage, and access to care. Advocated for the passage of the Newborn Screening Saves Lives Reauthorization Act, H.R. 482 / S. 350, to encourage investment in the national newborn screening program in order to detect more neuromuscular conditions early to speed appropriate interventions for patients. Advocated for robust funding of the national newborn screening program. Advocated for increased funding for National Institutes of Health, Food and Drug Administration, Health Resources and Services Administration, Centers for Disease Control and Prevention, and other health agencies that conduct research on neuromuscular disease and provide services to those with these conditions. Advocated for adequate, affordable, accessible health coverage for individuals with neuromuscular conditions. Advocated for the swift funding and implementation of the ACT for ALS Act (S.1813 and H.R.3537). Advocated for access to healthcare via telemedicine/telehealth throughout and after the COVID-19 public health emergency. Advocated for closure of the Medicaid coverage gap and the permanence of the Advanced Premium Tax Credits as part of the Build Back Better Act. Advocated for a robust paid medical leave program. Advocated for increased funding of home and community-based services (HCBS). Supported the passage of the e Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030/S. 2706) Advocated for reforms to the FDA Accelerated Approval program as part of the FDA user fee reauthorizations Advocated for the creation of an FDA regulatory pathway for diagnostics, including lab-developed tests and invitro diagnostics. Drafted recommendations to the Centers for Medicare and Medicaid Services on strengthening the Medicaid program. Supported the Administrations efforts to withdraw the previous Administrations Public Charge rule. Submitted recommendations to the Department of Health and Human Services on the implementation of section 504 of the Rehabilitation Act. Supported greater appropriations for Consumer Assistance Programs Advocated to the Architectural and Transportation Barriers Compliance Board (ATBCB) for amended Standards for Accessible Medical Diagnostic Equipment. Advocated for the passage of the RARE Act (S. 4185) as part of the Senate FDA User Fee process. Commented on fixing the ACA Family Glitch to the Treasury Department Supported reforms to the HCPCS coding system. Supported passage of the Ending the Diagnostic Odyssey Act Advocated for the passage of the Accelerating Kids Access to Care Act Advocated for certain provisions within the Cures 2.0 Legislation (H.R.6000) Support the passage of the Precision Medicine for Children Act Advocated for the passage of the HCBS Access Act Supported the passage of the Stop the Wait Act (S. 3575 / H.R. 6583)
2022 · second_quarter · Health Issues
HR 5776, the Build Back Better Act; HR 4385 / S 3080, the Cancer Drug Parity Act; HR 5030 / S 2706, the Diverse Trials Act; HR 7630 / 4120, Childhood Cancer STAR Reauthorization Act; HR 5416, the Give Kids a Chance Act; HR 6584, the DEPICT Act; HR 7512, the Protecting Patients from Deceptive Health Plans Act; HR 7667, the Food and Drug Amendments Act; specifically Title V; HR 8845, the NIH Clinical Trial Diversity Act; HR 8324, the Health Share Transparency Act; S 4185, the RARE Act; S 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act; S 4294, Pharmacy Benefit Manager Transparency Act of 2022; FDA regulations regarding sites of delivery for clinical trial services; federal regulation of Short Term Limited Duration Insurance and other non-ACA compliant insurance plans; implementation of the No Surprises Act (enacted in the 116th Congress); Consumer Assistance Programs;
Client expense: $170,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · second_quarter · Health Issues
Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, cancer survivorship, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, cannabis research, and wellness, including: The Build Back Better Act, HR 5376 & budget reconciliation discussions - ACA tax credits permanency HR 1550, The Prevent HPV Cancers Act S 464/HR 2163 Safe Step Act S. 699, Women and Lung Cancer Research and Preventive Services Act of 2021 HR 623, Gabriella Miller Kids First Research Act 2.0 S. 4260, The Palliative Care and Hospice Education and Training Act Provider Training in Palliative Care Act, S 2890 Issues related to the proposed HELP workforce proposal. Issues related to the possible introduction of the 21st Century Cures Act version 2.0 Regulations implementing the No Surprises Act Proposed Rule on Affordability of Employer Coverage for Family Members of Employees, REG-114339-21 Regulations related to short term limited duration health insurance plans OMB RFI on health equity - comments DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language Reducing Hereditary Cancer Act of 2021 - DWS, Slotkin, Miller-Meeks, and Davis Personal Care Products Safety Act - Feinstein, Collins H.R. 6638 - Reducing COVID-19 Disparities by Investing in Public Health Act of 2021 The VALID Act - DeGette, Bennet, Burr, Buschon DIVERSE Trials Act - H.R.5030/ S.2706 DEPICT Act Give Kids a Chance Act, H.R. 6972 NIH Clinical Trials Diversity Act HR 7667, Food and Drug Amendments Act Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, S 4348 S. 4185, the Retaining Access and Restoring Exclusivity (RARE) Act Potential legislation on cancer survivorship being developed by Rep. Wasserman Schultz Health Equity and Accountability Act, HR 7585
2022 · second_quarter · Health Issues
21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Biosimilars ---H.R.7035: Biologics Market Transparency Act ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Families First Coronavirus Response Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---TRIPS IP Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.4472: Better Empowerment Now To Enhance Framework and Improve Treatments (BENEFIT) Act ---H.R.4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1644 Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies ADAPT Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4351: Enhanced Access to Affordable Medicines Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.1959: Preserving Patient Access to Compounded Medications Act of 2019 ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Counterfeiting ---Drug Shortages ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4418: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of Consolidated Appropriations Act for FY 2021 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Implementation of Consolidated Appropriations Act for FY 2021 ---Pricing and Rebates Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---S.4184 Retaining Access and Restoring Exclusivity (RARE) Act ---Build Back Better Act (Discussion Draft Senate) ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---Implementation of Consolidated Appropriations Act for FY 2021 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of Consolidated Appropriations Act for FY 2021 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Recovery of Routine Immunizations ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021
Client expense: $3,740,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $200,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Council on Disability, Natl Institutes of Health (NIH), SENATE, Treasury, Dept of
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
Client expense: $1,200,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office
Client expense: $1,200,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, White House Office
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Client expense: $3,220,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
Client expense: $200,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Council on Disability, Natl Institutes of Health (NIH), SENATE, Treasury, Dept of
Client expense: $940,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), White House Office
Client expense: $3,120,000 · 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 Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office