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vs 9,698 other HR bills in the 117th — cohort avg 63d
Diverse and Equitable Participation in Clinical Trials Act or the DEPICT Act This bill requires applications for an investigational use exemption of a new drug or medical device to include information about the demographic diversity of the clinical trial population and addresses related issues. (Generally, a developer of a new drug or device may seek an investigational use exemption to facilitate clinical investigations, as part of the process to obtain approval to sell that drug or device.) Specifically, the Food and Drug Administration (FDA) must issue regulations to require applications for such exemptions to include certain information, including (1) demographic data disaggregated by subgroup, where such data is available, about the expected or potential patient population; (2) the applicant's enrollment targets for the clinical trials involved, disaggregated by age group, sex, race, and ethnicity; (3) a diversity plan for how the applicant will meet these targets; and (4) what is known about the patient population, such as comorbidities. The regulations must also require certain applicant reports to the FDA to address issues related to demographic diversity in clinical trials and product safety and effectiveness for demographic subgroups. The bill also authorizes the FDA to, in certain instances, require additional studies or surveillance after a drug or device has been approved if the clinical trials used in the application process did not meet the demographic enrollment targets.
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Filing registrants (24)
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2023 · second_quarter · Health Issues
Patient Access Issues Healthcare Appropriations The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 CDC Appropriation NIH Report Language S.464 Safe Step Act S. 2706 DIVERSE Trials Act H.R. 5801 HELP Copays Act H.R. 6584 DEPICT Act
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Client expense: $1,760,000 · Firm income: Not reported
2022 · fourth_quarter · Health Issues
The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 CDC Appropriation NIH Report Language S.464 Safe Step Act S. 2706 DIVERSE Trials Act H.R. 5801 HELP Copays Act H.R. 6584 DEPICT Act
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
H.R. 379/S. 104 - Improving Social Determinants of Health Act; bill to require the Centers for Disease Control and Prevention (CDC) to establish a program to improve health outcomes and reduce health inequities by, for example, coordinating activities across the CDC. As part of the program, the CDC must award grants to eligible organizations to build capacity to address social determinants of health. H.R. 469 - Comprehensive Breast Reconstruction Act of 2021; bill provides for Medicare, Medicaid, and private health insurance coverage of certain tattooing services in connection with post-mastectomy breast reconstruction, and aligns the scope of Medicare and Medicaid coverage of such breast reconstruction with that of private health insurance. H.R. 5030/S.2706 - DIVERSE Trials Act; A bill to require FDA to issue guidance on decentralized clinical trials to promote meaningful demographic/geographic diversity in patient engagement, expand reporting by laboratories that test for and diagnose COVID-19, and require a study on data collection and data sharing during public health emergencies H.R. 6000 - Cures 2.0 Act; a comprehensive healthcare and biomedical research bill H.R. 4794/S. 2533 - Making Advances in Mammography and Medical Options for Veterans Act; a bill to improve mammography services furnished by the Department of Veterans Affairs H.R. 4571/S. 2102 - Supporting Expanded Review for Veterans in Combat Environments (SERVICE) Act of 2021; a bill to expand eligibility for Veterans Health Administration mammography screenings to veterans who served in certain locations during specified periods, including those who were exposed to toxic substances at such locations H.R. 6584 - Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes. S. 3799 - Prepare for and Respond to Existing Viruses, Emerging New Threats, (PREVENT) and Pandemics Act; a bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics. H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 S. 4260 - Palliative Care and Hospice Education and Training Act; a bill to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools, social work schools, and other programs, including physician assistant education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative medicine. H.R. 7667/S. 4348 - Food and Drug Amendments of 2022; a bill to reauthorize Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices. H.R. 9565/S. 5295- Comprehensive Cancer Survivorship Act; a bill to address the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment, in order to improve survivorship, treatment, transition to recovery and beyond, quality of life and palliative care, and long-term health outcomes, including by developing a minimum standard of care for cancer survivorship, irrespective of the type of cancer, a survivors background, or forthcoming survivorship needs, and for other purposes. Policies related to telehealth Policies to increase clinical trial diversity and access for underrepresented populations Policies related to genetic counseling and testing Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to the reauthorization of FDA User Fee Agreements Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 Policies related to the implementation of the Mammography Quality Standards Act Policies related to administration actions necessary in breast imaging and breast cancer diagnosis Comments regarding a request for information on establishing a National Directory of Healthcare Providers and Services
2022 · fourth_quarter · Health Issues
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 4390: Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act of 2021; all provisions of the bill H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill H.R. 6000: Cures 2.0 Act; all healthcare provisions of the bill H.R. 6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; all provisions of the bill H.R. 6833: Affordable Insulin Now Act; provisions related to the Prescription Drug User Fee Act Reauthorization H.R. 6963: Accelerated Approval Integrity Act of 2022; all provisions of the bill H.R. 6996: Accelerating Access for Patients Act of 2022; all provisions of the bill H.R. 7667: Food and Drug Amendments of 2022; provisions related to drug development user fees S. 2706: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill S. 4348: Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022; provisions related to drug development user fees S. 4535: Food and Drug Administration Simple Reauthorization (FDASRA) Act of 2022; provisions related to drug development user fees 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill General healthcare issues surrounding the COVID-19 pandemic General issues surrounding healthcare supply chain General discussions regarding drug cost and pricing policy issues General discussions related to the Cancer Moonshot Initiative and the Advanced Research Projects Agency for Health (ARPA-H) General discussion related to the Prescription Drug User Fee Act Reauthorization
| Democratic |
| GA |
| Deborah K. Ross | Democratic | NC |
| Doris O. Matsui | Democratic | CA |
| Grace F. Napolitano | Democratic | CA |
| Jahana Hayes | Democratic | CT |
| Jimmy Panetta | Democratic | CA |
| Lauren Underwood | Democratic | IL |
| Mark DeSaulnier | Democratic | CA |
| Michael F. Doyle | Democratic | PA |
| Robin L. Kelly | Democratic | IL |
| Susan Wild | Democratic | PA |
| Ted Lieu | Democratic | CA |
| Yvette D. Clarke | Democratic | NY |
| Zoe Lofgren | Democratic | CA |
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
Client expense: $50,000 · 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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE
Client expense: $550,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
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 · Medical/Disease Research/Clinical Labs
DIVERSE Trials Act, HR 5030/S 2706 HR 623, Gabriella Miller Kids First Research Act 2.0 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language DEPICT Act, HR 6584 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
Client expense: $1,990,000 · 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, 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
H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 1730/S. 670- Speeding Therapy Access Today Act H.R. 1946, S. 1873. Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 5030/ S. 2706 DIVERSE Trials Act HR 5376, Inflation Reduction Act reconciliation bill; Medicare price negotiation provision and Part D redesign; Preventative healthcare services and screenings; Issues related to preventative services and screenings for underrepresented communities H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 Accelerating Access for Patients Act; H.R.7667 - Food and Drug Amendments of 2022; S. 1548, H.R. 3085/H.R. 7845. ENACT Act of 2021 S.4348 - FDASLA Act of 2022; General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; general issues related to health equity in rare disease and clinical trials; general issues related to diagnostics for patients with rare diseases; general issues related to pharmacy benefit managers (PBMs); general issues related to insurance coverage of specialty treatments Issues related to clinical trial diversity COVID-19; COVID-19 vaccine and therapy development Climate, sustainability, and environment; Sustainability & Zero Carbon; Items related to environmental sustainability (including eliminating GHG emissions from pMDIs) and our Ambition Zero Carbon efforts. E-Labeling EVUSHELD Issues related to repeal of the Medicaid AMP Cap. Issues related to drug pricing, IRA Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees;
Client expense: $1,170,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
Drug Regulation, Approval, Clinical Trial Diversity and FDA User Fees; Cancer Moonshot Items related to the Administrations Cancer Moonshot initiative; H.R. 6000-CURES Act 2.0 H.R. 5030/ S. 2706- DIVERSE Trials Act H.R. 6584- DEPICT Act H.R. 3085/S. 1548- ENACT Act of 2021 H.R. 7845- NIH Clinical Trial Diversity Act of 2022 H.R. 1946/, S. 1873- Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021
Client expense: $1,170,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Pharmacy
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADAPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. S.4918: Increasing Prescription Drug Competition Act. Labeling of Generic Drugs and Biosimilars. H.R.9011: Updated Drug Labeling for Patient Safety Act. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic Carveouts Patent Protected Information in Drug Labels Including Issues Related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize Domestic Manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. S.6: Biosimilar Red Tape Elimination Act. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Energy & Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. Implementation of the Inflation Reduction Act.. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act. H.R.2617: Consolidated Appropriations Act of 2023.
Client expense: $900,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), SENATE
2022 · fourth_quarter · Health Issues
H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products HR 1978 - Protecting Seniors Through Immunization Act H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing, patient assistance H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180); PDUFA provisions related to intellectual property H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Issues related to HFC's Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Veterans' Affairs issues related to product sampling Provisions related to the importation of HFCs, necessary for MDI production. P.L.116-260 - AIM Act - EPA Propellant Allowances for metered dose inhaler manufacturing PDUFA riders legislation (Accelerated Approval, Clinical Trial Diversity, Q1Q2)
Client expense: $860,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 3085: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act - Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180) H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 7900: National Defense Authorization Act for Fiscal Year 2023 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Notice of Proposed Rulemaking; 340B Drug Pricing Program; Administrative Dispute Resolution; 87 Fed. Reg. 73516 (Nov. 30, 2022) Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Client expense: $6,610,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Office of Management & Budget (OMB), SENATE
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Client expense: $880,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office
2022 · fourth_quarter · Health Issues
Health disparities Access to clinical trials for underrepresented populations Improving Social Determinants of Health Act (S.104/H.R.379) Comprehensive Breast Reconstruction Act of 2021 (H.R. 469) DIVERSE Trials Act (H.R. 5030/S. 2706) Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (H.R.6584); a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes CURES 2.0 Act (H.R. 6000) Policies related to cancer survivorship Policies related to medications access in during emergencies Polices related to PBM and drug cost transparency Policies related to COVID-19 vaccination distribution Policies impacting immunocompromised people, including COVID-19 vaccination and monoclonal antibody distribution Policies related to reducing the cost of cancer treatment for patients Policies related to decline in breast cancer screenings during the COVID-19 pandemic Policies related to genetic counseling and screening Policies related to reauthorization of user fees at the Food and Drug Administration (H.R. 7667/ S. 4348) H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 Advanced Research Project Agency-Health Act (H.R.5585) Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act (S.3799) Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 H.R. 9565/S. 5295- Comprehensive Cancer Survivorship Act Policies related to the reauthorization of FDA User Fee Agreements Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017 Policies related to the implementation of the Mammography Quality Standards Act Policies related to administrative actions necessary in breast imaging and breast cancer diagnosis Policies related to the regulation of diagnostic devices Section 1557, Nondiscrimination in Health Programs and Activities (RIN Number 0945-AA17) Request for Information on establishing a National Directory of Healthcare Providers and Services
Client expense: Not reported · Firm income: $40,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE
2022 · fourth_quarter · Health Issues
FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348); Food and Drug Amendments of 2022 (H.R. 7667); Diverse and Equitable Participation in Clinical Trials Act (H.R. 6584); Advanced Research Project Agency-Health Act (H.R. 5585); America COMPETES Act of 2022 (H.R. 4521); Interagency Patent Coordination and Improvement Act of 2022 (S. 4430); Increasing Prescription Drug Competition Act (S. 4918); Consolidated Appropriations Act, 2023 (H.R. 2617); PASTEUR Act of 2021 (H.R. 3932/S. 2076); Biologics Competition Act of 2022 (H.R. 8877); Give Kids a Chance Act of 2022 (S. 4125/H.R. 6972); Orange Book listing issues; Bayh-Dole Act.
Client expense: Not reported · Firm income: $100,000
2022 · fourth_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; Proposed FDA guidance on gastroparesis clinical trials; Bayh-Dole march-in rights policy issues; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; Discussions related to Most Favored Nation/International Reference Pricing; H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act - provisions related to lower prescription drug prices; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; H.R. 19, Lower Costs, More Cures Act of 2021 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 5260, Reduced Costs and Continued Cares Act - provisions related to prescription drug prices; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA), clinical trial diversity, and accelerated approval provision; H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; S. 3799, PREVENT Pandemics Act - provisions related to pandemic readiness; Discussions on Customs Border Protection changes impacting southern border plasma collections; Discussions to establish a Congressional Plasma Caucus; Discussions related to Cancer Moonshot Initiatives; S. 4293, Pharmacy Benefit Manager Transparency Act of 2022 - provisions related to data protection; Issues related to Dengue vaccines;
Client expense: $780,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Issues related to health insurance, including Medicare, Medicaid and short term plans. Issues related to prescription drug costs and affordability. Issues related to the No Surprises Act and patient protections. Issues related to agency funding for medical and cancer research. Issues related to H.R. 3089/S. 1544, the Accelerating Kids' Access to Care Act and H.R. 7630/S.4120, the Childhood Cancer STAR Reauthorization Act. Issues related to clinical trial diversity including H.R. 5030/S.2706, DIVERSE Trials Act, in H.R. 6584, DEPICT Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
S. 411: MOMMA Act - Improve data collection, interventions, and expanded access for postpartum women S. 464/HR 2163: Safe Step Act-Implement transparency guidelines for step-therapy utilization S.1975/H.R. 3755: Womens Health Protection Act - Protect patient-physician relationship by allowing physicians to provide evidence-based womens health care S.1988: Protecting Rural Teleheath Access Act - Waive geographic restrictions and offer audio-only appointments S. 1893: Rural Physician Workforce Production Act - Provide federal support for rural residency training S1958/HR3671:DOC Act - Permanent authorization of THCGME program HR 379 Improving Social Determinants of Health Act: Would create a new SDoH program at the CDC HR 959: Black Maternal Health Momnibus Act - Comprehensive reforms to address maternal health challenges HR 976: Ensuring Transparent Honest Information on COVID-19 Act - Requires COVID-19 data reporting, including demographic information to the CDC, by states & localities & funds a study to examine public health data & infrastructure during & after the COVID-19 PHE. HR 1319: American Rescue Plan - Expansion of ACA coverage, investments in public health workforce, funding for COVID-19 response HR 1384: Mainstreaming Addiction Treatment Act of 2021- Eliminated the x-waiver HR 1848: LIFT America Act - Enhancing public health infrastructure, improve laboratory infrastructure, update care facilities, improve broadband infrastructure, and address social determinants of health HR 2125: Quit Because of Covid 19 Act - Would ensure that all Medicaid and CHIP enrollees have access to proven tobacco cessation treatments. HR 2347: Strengthening Vaccines for Childrens Act - Modifications to improve the Vaccine for Children (VFC) program HR 2418: Student Loan Forgiveness for Frontline Health Workers- Would forgive outstanding federal and private student loan debt for frontline physicians H.R. 5218: Collaborate in an Orderly and Cohesive Manner Act H.R. 4387/S.1675: Maternal Health Quality Improvement Act H.R. 5054: Physicians Serving Patients Act of 2021 H.R. 4770: Evaluating Disparities and Outcomes of Telehealth During the COVID-19 Emergency Act H.R. 5376: Build Back Better Act H.R. 4387/S. 1675: Maternal Health Quality Improvement Act H.R. 5218: Collaborate in an Orderly and Cohesive Manner Act H.R. 5541: Primary and Virtual Care Affordability Act S. 128: Primary Care Enhancement Act No Bill No: Physicians Serving Patients Act of 2021 No Bill No.: Congressional Primary Care Caucus;117th Congress membership in the bipartisan CPCC No Bill No.: Teaching Health Centers GME; Community Health Centers- National Health Service Corps; Special Diabetes Program; Special Diabetes Program for Indians - Increased funding and allocation of resources for teaching health center programs No Bill No.: Primary Care Patient Protection Act - Create a primary care benefit in high deductible health plans No Bill No.: No Surprise Bills for New Moms - Require health plans to cover newborns under mothers coverage for set time, SEP for enrollment post childbirth, and notification requirements No Bill No.: FY 2022 Appropriations Requests - CDC Programs (Climate/Health; Gun Violence Research; vaccine infrastructure); HRSA; AHRQ; CMS No Bill No.: Rural MOMS Act-Demonstration program to train physicians about maternal care in rural communities No Bill No.: COVID-19 Safe Birthing Act-Expand maternal telehealth for Medicaid beneficiaries; Medicaid/CHP post-partum coverage extension to one year No Bill No.: Anti-Racism in Public Health Act-Direct CDC to declare racism a public health crisis; establish a CDC-based center for addressing violence prevention No Bill No.: Equality Act-Provide affirmative, statutory nondiscrimination protections for LGBTQ Americans No Bill No.: Covid 19 vaccinations - Ensure Primary Care Physicians can access COVID-19 vaccines. No Bill No.: Telehealth Expansion - Preserve key telehealth flexibilities beyond COVID-19 PHE Affordable Insulin Now Act FY22 COVID-19 supplemental H.R. 7232: 9-8-8 and Parity Assistance Act Prevent Pandemics Act H.R. 7076: Supporting Children's Mental Health Care Access Act H.R. 3085: Equity in Neuroscience and Alzheimer's Clinical Trials Act H.R. 6584: Diverse and Equitable Participation in Clinical Trials Act H.R. 4122/S. 3658: REDI Act H.R. 1667: Dr. Lorna Breen Health Care Provider Protection Act S. 1893: Workforce Production Act of 2021 H.R. 7894/S.4347: Affordability is Access Act H.R. 8297: Ensuring Access to Abortion Act S.4306: Improving Access to Behavioral Health Integration Act S. 4170: Mental Health Reform Reauthorization Act H.R. 7666: Restoring Hope for Mental Health and Well-Being Act H.R. 7232: 9-8-8 and Parity Assistance Act H.R. 7076: Supporting Children's Mental Health Care Access Act S. 4408: Health and Location Data Protection Act No Bill No.: Behavioral health integration w/i primary care H.R. 5376: Inflation Reduction Act S. 198: Data Mapping to Save Moms' Lives Act H.R. 4040: Advancing Telehealth Beyond COVID-19 Act of 2021 Consolidated Appropriations Act of 2023
Client expense: $788,015 · Firm income: Not reported
Government targets: 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 · Health Issues
S 464/HR 2163 Safe Step Act - implementing safe guards around step therapy (fail first) programs in ERISA regulated plans HR 1550 - PREVENT HPV Cancers Act of 2021 HR 3258 - TACT Act of 2021- improve patient access to anti-cancer oral medications HR 4385/S 3080- Cancer Drug Parity Act of 2021- oral parity HR 5801- HELP Copays Act- copay accumulator programs S 3039/HR 2503- Social Determinants Accelerator Act of 2021- SDOH HR 5030/S 2706- DIVERSE Trials Act- access to clinical trials HR 6584- DEPICT Act- access to clinical trials HR 6000- Cures 2.0 HR 5963/S 3611- Provider Relief Fund Improvement Act- extends deadlines, expands the uses of, and makes other changes pertaining to the Provider Relief Fund HR 4450/S 2352- Access to Infertility Treatment and Care Act- requires private insurance to cover fertility preservation services ARPA-H FDA User Fee Agreement policy riders: increasing diversity in clinical trials, improvements to accelerated approval pathway, expanded use of real world data, and in vitro clinical tests HR 7630/S 4120- Childhood Cancer STAR Reauthorization Act of 2022- reauthorizes the STAR Act through FY2028 S 4293- Pharmacy Benefit Manager Transparency Act of 2022- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 4430- Interagency Patent Coordination and Improvement Act of 2022- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA S 5295/HR 9565- Comprehensive Cancer Survivorship Act- addresses the health of cancer survivors and unmet needs that survivors face through the entire continuum of care from diagnosis through active treatment and posttreatment HR 4128/S 2209- VALID Act of 2021- requires FDA to regulate in vitro clinical tests
Client expense: $80,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
Bills -H.R. 2163/S. 464 - Safe Step Act -S.1773 - Prescription Drug Pricing Dashboard Act -H.R. 5376 - Build Back Better Act -H.R. 3684- Infrastructure Investment and Jobs Act -H.R. 5801 - Help Ensure Lower Patient (HELP) Copays Act -S.2076/H.R. 3932 PASTEUR Act -S. 3799- PREVENT Pandemics Act -H.R.4521 - COMPETES Act of 2022 -S.1260 - United States Innovation and Competition Act of 2021 -H.R.6963 - Accelerated Approval Integrity Act of 2022 -H.R.6996 - Accelerating Access for Patients Act of 2022 -H.R. 2565 / S.2952 the FDA Modernization Act -H.R. 6972 - Give Kids a Chance Act -H.R. 1730 - STAT Act -H.R. 7032 - Increasing Transparency in Generic Drug Applications Act -H.R. 5030/S. 2706 - DIVERSE Trials Act -H.R. 6584 - DEPICT Act -H.R. 9476- Influenza Act of 2022 Issues -Issues related to the 340B Drug Discount Program -Issues relating to drug pricing -Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives -Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars -General education about policies impacting pharmaceutical development, approval, reimbursement and pricing -Issues related to healthcare legislation -Patient access to Part B medicines during the COVID-19 public health emergency -Issues related to health equity, diversity, and inclusion in clinical trials -Issues related to advanced development and procurement of medical countermeasures (MCMs) -Issues related to patient assistance and access -Issues relating to privacy and securing the data of and personal information of consumers -Issues relating to medical research data -Issues relating to screening and diagnostics -Issues related to public health preparedness and response -Issues related to awareness about diabetic eye diseases in minority populations
Client expense: $1,630,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 2471 Consolidated Appropriations Act, FY2022 S.2076/H.R. 3932 PASTEUR Act H.R.7667 - Food and Drug Amendments of 2022 S.4348 - FDASLA Act of 2022 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act H.R.3085 - ENACT Act of 2021 -Issues related to public health protection including influenza development and preparedness -Issues related to antimicrobial and antiviral research and product development -Issues related to novel coronavirus and COVID-19 research and product development -Issues related to drug development including PDUFA and Cures 2.0
Client expense: $1,630,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · fourth_quarter · Health Issues
General Parkinson's disease information about symptoms, triggers, health coverage, health costs, social determinants of health related to Parkinson's disease and data collection, research, and health access for underserved communities. H.R. 8585/S. 4851, the National Plan to End Parkinson's Act - to require the U.S. Department of Health and Human Services (HHS) to carry out a project to prevent and cure Parkinson's disease. Among other components of the project, HHS must (1) implement and periodically update a national plan to coordinate and guide efforts to prevent and cure the disease; (2) improve diagnosis, treatment, and care of those with the disease; and (3) address health and other disparities related to the disease. HHS must also conduct annual assessments on the preparation for and response to the increased burden of Parkinson's disease. In addition, the bill establishes a council, comprised of federal and nonfederal stakeholders, to advise HHS on and make recommendations concerning the prevention and cure of Parkinson's disease. Establishing Parkinson's disease ICD-10-CM codes to assist in the continuation and coordination of care and to allow researchers to gather more data to study the progression of Parkinson's among people living with the disease. Expanding access to health care for people living with Parkinson's via telehealth by removing Medicare telehealth geographic and originating site restrictions, extending coverage and reimbursement for health care providers who bill Medicare for providing services via telehealth (including seeing new patients and audio-only telehealth for clinically appropriate services/visits), ensuring payment parity for telehealth and in-person services, and removing Medicare in-person requirements for accessing mental health services via telehealth. H.R. 2617, the Consolidated Appropriations Act, 2023 Establishing separate Medicare payment requirements for diagnostic radiopharmaceuticals, including DaTscans, so health care providers are adequately reimbursed for furnishing diagnostic tests to help validate patients Parkinsons diagnoses. S. 2609/H.R. 4479, Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2021 S. 464/H.R. 2163, the Safe Step Act - to amend the Employee Retirement Income Security Act of 1974 (ERISA) to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol to enable people living with Parkinsons disease to access the medications they need to best manage their disease S.4906 Advocating for reauthorization of CDCs National Neurological Conditions Surveillance System (NNCSS) S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT), and Pandemics Act S. 253/H.R.8454, the Cannabidiol and Marihuana Research Expansion Act/ Medical Marijuana and Cannabidiol Research Expansion Act S. 1467/H.R. 2916, the VA Medicinal Cannabis Research Act H.R. 5657, the Medical Marijuana Research Act H.R. 3617, the Marijuana Opportunity Reinvestment and Expungement Act H.R. 2916/S. 1467, the VA Medical Cannabis Research Act of 2021 H.R. 3105, the Common Sense Cannabis Reform for Veterans, Small Businesses, and Medical Professionals Act S. 1670/H.R. 3321, the Credit for Caring Act H.R. 253, the Adult Day Care Center Enhancement Act H.R. 6000, the Cures 2.0 Act H.R. 4521, the America COMPETES Act of 2022 H.R. 2565/S. 2952, the FDA Modernization Act of 2021 H.R. 5435 BRAIN (Bringing Regulatory Advances Into Neuroscience) Act of 2021 S. 3427, the Neuroscience Center of Excellence Act of 2021 H.R. 6584, the DEPICT (Diverse and Equitable Participation in Clinical Trials) Act S. 331, ABLE (Achieving a Better Life Experience) Age Adjustment Act
Client expense: $20,000 · Firm income: Not reported
Government targets: Centers For Disease Control & Prevention (CDC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Office of Science & Technology Policy (OSTP), SENATE
2022 · fourth_quarter · Health Issues
S. 4446 - Modernizing Accelerated Approval Pathway Act of 2022; H.R. 6584 - DEPICT Act; S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022; H.R. 7667 - Food and Drug Amendments of 2022; Consolidated Appropriations Act, 2023 (PL 117-328), Division FF, Title III - Food and Drug Administration, Subtitle B - Drugs and Biologics and Subtitle F, Chapter 1 - Clinical Trial Diversity and Modernization; Package Inserts/eLabeling Issues (H.R. 7559 - Prescription Information Modernization Act of 2022).
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
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
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
2022 · third_quarter · Medical/Disease Research/Clinical Labs
DIVERSE Trials Act, HR 5030/S 2706 HR 623, Gabriella Miller Kids First Research Act 2.0 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language DEPICT Act, HR 6584 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
Client expense: $1,200,000 · 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, White House Office
2022 · third_quarter · Health Issues
H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;
Client expense: $930,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office
2022 · third_quarter · Health Issues
H.R. 379/S. 104 - Improving Social Determinants of Health Act; bill to require the Centers for Disease Control and Prevention (CDC) to establish a program to improve health outcomes and reduce health inequities by, for example, coordinating activities across the CDC. As part of the program, the CDC must award grants to eligible organizations to build capacity to address social determinants of health. H.R. 469 - Comprehensive Breast Reconstruction Act of 2021; bill provides for Medicare, Medicaid, and private health insurance coverage of certain tattooing services in connection with post-mastectomy breast reconstruction, and aligns the scope of Medicare and Medicaid coverage of such breast reconstruction with that of private health insurance. H.R. 5030/S.2706 - DIVERSE Trials Act; A bill to require FDA to issue guidance on decentralized clinical trials to promote meaningful demographic/geographic diversity in patient engagment, expand reporting by laboratories that test for and diagnose COVID-19, and require a study on data collection and data sharing during public health emergencies H.R. 6000 - Cures 2.0 Act; a comprehensive healthcare and biomedical research bill H.R. 4794/S. 2533 - Making Advances in Mammography and Medical Options for Veterans Act; a bill to improve mammography services furnished by the Department of Veterans Affairs H.R. 4571/S. 2102 - Supporting Expanded Review for Veterans in Combat Environments (SERVICE) Act of 2021; a bill to expand eligibility for Veterans Health Administration mammography screenings to veterans who served in certain locations during specified periods, including those who were exposed to toxic substances at such locations H.R. 6584 - Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes. S. 3799 - Prepare for and Respond to Existing Viruses, Emerging New Threats, (PREVENT) and Pandemics Act; a bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics. Efforts to introduce a bill regarding clinical trial diversity nicknamed the The Clinical Trial Diversity Act H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 S. 4260 - Palliative Care and Hospice Education and Training Act; a bill to increase the number of permanent faculty in palliative care at accredited allopathic and osteopathic medical schools, nursing schools, social work schools, and other programs, including physician assistant education programs, to promote education and research in palliative care and hospice, and to support the development of faculty careers in academic palliative medicine. H.R. 7667/S. 4348 - Food and Drug Amendments of 2022; a bill to reauthorize Food and Drug Administration (FDA) user fee programs for certain drugs and devices, establishes requirements to increase diversity in clinical trials, and modifies requirements relating to the overall supply chain for drugs and devices. Policies related to telehealth Policies related to COVID-19 vaccination and monoclonal antibody distribution Policies to increase clinical trial diversity and access for underrepresented populations Policies related to genetic counseling and testing Policies related to cancer survivorship Policies related to PBM and drug cost transparency Policies related to the reauthorization of FDA User Fee Agreements Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017
Client expense: $50,000 · 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), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE
2022 · third_quarter · Medical/Disease Research/Clinical Labs
DIVERSE Trials Act, HR 5030/S 2706 HR 623, Gabriella Miller Kids First Research Act 2.0 Issues related to the possible introduction of the 21st Century Cures Act version 2.0 DICT RFI - Eshoo DICT Ancillary Costs legislation/Menendez, Scott, Smith, Young, Ruiz House/Senate Appropriations Committee FDA DICT report language DEPICT Act, HR 6584 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
Client expense: $1,200,000 · 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, White House Office
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
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
2022 · third_quarter · Health Issues
H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R.1978 - Protecting Seniors Through Immunization Act of 2021 H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: DIVERSE Trials Act- Diversifying Investigations Via Equitable Research Studies for Everyone H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research S. 581/H.R. 2170: HAPI Act; Medicaid financial barriers HR 5605 PrEP Assistance Act H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act H.R. 5376 Inflation Reduction Act - provisions related to vaccines and pharmaceuticals H.R. 4127: DISARM Act Act Provisions related to antimicrobial drug development H.R. 3932/S. 2076: PASTEUR Act - authorizes the Department of Health and Human Services (HHS) to enter into subscription contracts for critical-need antimicrobial drugs. H.R. 3655: Vaccine Injury Compensation Modernization Act H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) S. 912/H.R. 1978: Protecting Seniors Through Immunization Act H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Dietary Supplement Health and Education Act Reform Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse and fentanyl policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues High deductible health plans/HSA and FSA for dietary supplements policy issues Final Rule; Importation of Prescription Drugs Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act CREATES/USICA INFORM Consumers Act SHOP SAFE Act Food and Drug Amendments of 2022 Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Veterans' Affairs issues related to product sampling Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates H.R. 4121, PRO Seniors Act, provisions related to drug rebates Protecting American Innovation Act, provisions related to intellectual property
Client expense: $1,390,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
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
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
H.R. 3: Elijah E. Cummings Lower Drug Costs Now Act; all provisions of the bill H.R. 4390: Preserving Rules Ordered for The Entities Covered Through (PROTECT) 340B Act of 2021; all provisions of the bill H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill H.R. 6000: Cures 2.0 Act; all healthcare provisions of the bill H.R. 6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act; all provisions of the bill H.R. 6833: Affordable Insulin Now Act; provisions related to the Prescription Drug User Fee Act Reauthorization H.R. 6963: Accelerated Approval Integrity Act of 2022; all provisions of the bill H.R. 6996: Accelerating Access for Patients Act of 2022; all provisions of the bill H.R. 7667: Food and Drug Amendments of 2022; provisions related to drug development user fees S. 2706: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act; all provisions of the bill S. 4348: Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022; provisions related to drug development user fees S. 4535: Food and Drug Administration Simple Reauthorization (FDASRA) Act of 2022; provisions related to drug development user fees 2021 Notice of Benefit and Payment Parameters Proposed Rule - 340B Drug Pricing Program policy issues P.L. 117-169 (H.R. 5376): Inflation Reduction Act of 2022; all provisions of the bill General healthcare issues surrounding the COVID-19 pandemic General issues surrounding healthcare supply chain General discussions regarding drug cost and pricing policy issues General discussions related to the Cancer Moonshot Initiative and the Advanced Research Projects Agency for Health (ARPA-H) General discussion related to the Prescription Drug User Fee Act Reauthorization
Client expense: $530,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
2022 · third_quarter · Health Issues
Health disparities Access to clinical trials for underrepresented populations Improving Social Determinants of Health Act (S.104/H.R.379) Comprehensive Breast Reconstruction Act of 2021 (H.R. 469) DIVERSE Trials Act (H.R. 5030/S. 2706) Diverse and Equitable Participation in Clinical Trials (DEPICT) Act (H.R.6584); a bill to direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes CURES 2.0 Act (H.R. 6000) Policies related to cancer survivorship Policies related to medications access in during emergencies Polices related to PBM and drug cost transparency Policies related to COVID-19 vaccination distribution Policies impacting immunocompromised people, including COVID-19 vaccination and monoclonal antibody distribution Policies related to reducing the cost of cancer treatment for patients Policies related to decline in breast cancer screenings during the COVID-19 pandemic Policies related to genetic counseling and screening Policies related to reauthorization of user fees at the Food and Drug Administration (H.R. 7667/ S. 4348) H.R. 7845 NIH Clinical Trial Diversity Act; a bill to direct the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to take certain steps to increase clinical trial diversity, and for other purposes. H.R. 8185/S. 4440 - Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act; a bill to amend the Public Health Service Act to reauthorize and improve the National Breast and Cervical Cancer Early Detection Program for fiscal years 2023 through 2027 Advanced Research Project Agency-Health Act (H.R.5585) Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act (S.3799) Policies related to the implementation of the Breast Density and Mammography Reporting Act of 2017
Client expense: Not reported · Firm income: $42,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE
2022 · third_quarter · Medical/Disease Research/Clinical Labs
H.R. 2471 Consolidated Appropriations Act, FY2022 S.2076/H.R. 3932 PASTEUR Act H.R.7667 - Food and Drug Amendments of 2022 S.4348 - FDASLA Act of 2022 H.R.6963 - Accelerated Approval Integrity Act of 2022 H.R.6996 - Accelerating Access for Patients Act of 2022 H.R. 2565 / S.2952 the FDA Modernization Act H.R. 6972 - Give Kids a Chance Act H.R. 1730 - STAT Act H.R. 7032 - Increasing Transparency in Generic Drug Applications Act H.R. 5030/S. 2706 - DIVERSE Trials Act H.R. 6584 - DEPICT Act H.R.3085 - ENACT Act of 2021 -Issues related to public health protection including influenza development and preparedness -Issues related to antimicrobial and antiviral research and product development -Issues related to novel coronavirus and COVID-19 research and product development -Issues related to drug development including PDUFA and Cures 2.0
Client expense: $2,430,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;
Client expense: $910,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office
2022 · third_quarter · Health Issues
H.R. 5: Equality Act H.R. 623: Gabriella Miller Kids First Research Act 2.0 H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act - Provisions related to FDA policy and approvals H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 3085: ENACT Act of 2021- Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act H.R. 5030: Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169) H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022 H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act H.R. 7008: Pre-Approval Information Exchange Act of 2022 H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act H.R. 7474: Pharmaceutical Research and Transparency Act of 2022 H.R. 7667: Food and Drug Amendments Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes H.R. 7845: NIH Clinical Trial Diversity Act of 2022 H.R. 8152: American Data Privacy and Protection Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes - Provisions related to 340B drug discount program S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1548: ENACT Act of 2021 - Sets out activities and requirements to increase the participation of underrepresented populations in research and clinical trials for Alzheimers disease and related dementias S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act S. 4215: Give Kids a Chance Act of 2022 S. 4348: FDASLA Act of 2022 - To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4535: Food and Drug Administration Simple Reauthorization Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Cancer Moonshot Initiative Healthy Future Task Force RFIs - Severity, Affordability, Modernization and Treatments 21st Century Cures 2.0 Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues Direct to consumer advertising policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act policy issues Expanded access policy issues Antimicrobial resistance (AMR) policy issues Mental health policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues Prescription drug abuse policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues COVID-19 policy issues Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Client expense: $7,270,000 · Firm income: Not reported
Government targets: 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)
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
21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot
Client expense: $850,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office
2022 · third_quarter · Pharmacy
Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.
Client expense: $720,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE
2022 · third_quarter · Health Issues
FDA Safety and Landmark Advancements (FDASLA) Act (S. 4348); Food and Drug Amendments of 2022 (H.R.7667); Build Back Better Act (H.R. 5376); Diverse and Equitable Participation in Clinical Trials Act (H.R. 6584); Advanced Research Project Agency-Health Act (H.R. 5585); America COMPETES Act of 2022 (H.R. 4521); Interagency Patent Coordination and Improvement Act of 2022 (S. 4430); Food and Drug Administration Simple Reauthorization Act (S. 4535); Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 (H.R. 6833); Inflation Reduction Act (H.R. 5376); Pediatric testing for drugs; Increasing Prescription Drug Competition Act (S. 4918).
Client expense: Not reported · Firm income: $360,000
2022 · third_quarter · Health Issues
P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA), plasma awareness, and the orphan drug tax credit; Issues related to patient access of plasma therapies; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Issues related to prescription drug vial sizes; Proposals related to drug pricing, including House and Senate draft bills; Discussions related to co-pay accumulators; maximizers, alternate funding models; H.R. 6000, Cures 2.0 Act - provisions related to the pharmaceutical industry; Discussions related to amending P.L. 97-414, Orphan Drug Act; HHS/FDA Safe Importation Action Plan - provisions related to the importation of prescription drugs; 42 USC 1320a-7b, Anti-Kickback Statute; Advisory Committee on Heritable Disorders in Newborns and Children - issues related to newborn screening; H.R. 482, S. 350, Newborn Screening Saves Lives Reauthorization of 2021 - provisions related to newborn screening; S. 1281, To amend the CARES Act to expand a national awareness and outreach campaign to address the importance and safety of plasma donation, and for other purposes - provisions related to plasma donation; H.R. 3468, S. 1281, Plasma Donation Awareness Act - provisions related to requiring HHS to initiate a plasma donation awareness campaign much like the one required for blood donation in P.L. 116-136 (CARES Act); H.R. 2163, S. 464, Safe Step Act - provisions related to step therapy policy; Food and Drug Amendments of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); S. 4348, FDASLA Act of 2022 - provisions related to the reauthorization of Prescription Drug User Fee Act (PDUFA) and the Biosimilars User Fee Amendments (BsUFA); H.R. 5416, Give Kids a Chance Act - provisions related to establishing additional authorities of the FDA regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer, and for other purposes; H.R. 6584, DEPICT Act - provisions related to amending certain FDA regulations to increase clinical trial diversity; H.R. 5585, Advanced Research Project Agency-Health Act - provisions related to the establishment of the Advanced Research Projects Agency-Health to accelerate innovation in health and medicine by investing in high-risk, high-reward research projects; H.R. 6963, Accelerated Approval Integrity Act of 2022 - provisions related to strengthening requirements for post approval studies for drugs approved using accelerated approval; E.O. 14081 Advancing Biotechnology and Biomanufacturing Innovation;
Client expense: $1,580,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 CDC Appropriation NIH Report Language S.464 Safe Step Act S. 2706 DIVERSE Trials Act H.R. 5801 HELP Copays Act H.R. 6584 DEPICT Act
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
The Pharmacy Benefit Manager (PBM) Transparency Act of 2022 CDC Appropriation NIH Report Language S.464 Safe Step Act S. 2706 DIVERSE Trials Act H.R. 5801 HELP Copays Act H.R. 6584 DEPICT Act
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
S 464/HR 2163 Safe Step Act - implementing safe guards around step therapy (fail first) programs in ERISA regulated plans HR 1550 - PREVENT HPV Cancers Act of 2021 HR 3258 - TACT Act of 2021- improve patient access to anti-cancer oral medications HR 4385/S 3080- Cancer Drug Parity Act of 2021- oral parity HR 5801- HELP Copays Act- copay accumulator programs S 3039/HR 2503- Social Determinants Accelerator Act of 2021- SDOH HR 5030/S 2706- DIVERSE Trials Act- access to clinical trials HR 6584- DEPICT Act- access to clinical trials HR 6000- Cures 2.0 HR 5963/S 3611- Provider Relief Fund Improvement Act- extends deadlines, expands the uses of, and makes other changes pertaining to the Provider Relief Fund HR 4450/S 2352- Access to Infertility Treatment and Care Act- requires private insurance to cover fertility preservation services ARPA-H FDA User Fee Agreement policy riders: increasing diversity in clinical trials, improvements to accelerated approval pathway, expanded use of real world data, and in vitro clinical tests HR 7630/S 4120- Childhood Cancer STAR Reauthorization Act of 2022- reauthorizes the STAR Act through FY2028 S 4293- Pharmacy Benefit Manager Transparency Act of 2022- prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs S 4430- Interagency Patent Coordination and Improvement Act of 2022- establishes an interagency taskforce between the United States Patent and Trademark Office and the FDA
Client expense: $125,406 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
Issues related to drug pricing reform H.R.5376, Build Back Better Act S2891 Restoring America Invents Act S1435 affordable prescriptions for patients act H.R.2873 Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act Biosimilars reimbursement issues, no specific bill Supply Chain Issues, no specific bill Issues related to clinical trial diversity, HR 6584 DEPICT Act, HR5030 DIVERSE Trials Act, HR 7845 and S2706 NIH Clinical Trial Diversity Act of 2022 Issues related to biodefense issues, S3799 PREVENT Pandemics Act Issues related to cardiovascular disease awareness, S. 3018/ HR 3173 Improving Seniors Timely Access to Care Act, S.464 Safe Step Act and HR8295 Labor/HHS Appropriations bill H.R. 5801 HELP Copays Act Issues related to patient affordability issues, including copay cards, copay accumulators, National Benefit Payment Parameters FDA Issues; User Fee Reauthorization HR7667 Food and Drug Amendments Act and S4348 FDA safety and landmark advancement act H.R. 6963, the Accelerated Approval Integrity Act of 2022 H.R. 7047, a bill to amend Title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R. 6000, the Cures 2.0 Act H.R. 7008, the Pre-Approval Information Exchange Act S4293 Pharmacy benefit managers transparency act HR 8588Fair Care Act, 340B hospital reporting HR 4390 Protect 340B Act
Client expense: $3,150,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
Issues related to health insurance, including Medicare, Medicaid and short term plans. Issues related to prescription drug costs and affordability. Issues related to the No Surprises Act and patient protections. Issues related to agency funding for medical and cancer research. Issues related to H.R. 3089/S. 1544, the Accelerating Kids' Access to Care Act. Issues related to clinical trial diversity including H.R. 5030/S. 2706, DIVERSE Trials Act, in H.R. 6584, DEPICT Act, and in user fees reauthorization legislation.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
S. 411: MOMMA Act - Improve data collection, interventions, and expanded access for postpartum women S. 464/HR 2163: Safe Step Act-Implement transparency guidelines for step-therapy utilization S.1975/H.R. 3755: Womens Health Protection Act - Protect patient-physician relationship by allowing physicians to provide evidence-based womens health care S.1988: Protecting Rural Teleheath Access Act - Waive geographic restrictions and offer audio-only appointments S. 1893: Rural Physician Workforce Production Act - Provide federal support for rural residency training S1958/HR3671:DOC Act - Permanent authorization of THCGME program HR 379 Improving Social Determinants of Health Act: Would create a new SDoH program at the CDC HR 959: Black Maternal Health Momnibus Act - Comprehensive reforms to address maternal health challenges HR 976: Ensuring Transparent Honest Information on COVID-19 Act - Requires COVID-19 data reporting, including demographic information to the CDC, by states & localities & funds a study to examine public health data & infrastructure during & after the COVID-19 PHE. HR 1319: American Rescue Plan - Expansion of ACA coverage, investments in public health workforce, funding for COVID-19 response HR 1384: Mainstreaming Addiction Treatment Act of 2021- Eliminated the x-waiver HR 1848: LIFT America Act - Enhancing public health infrastructure, improve laboratory infrastructure, update care facilities, improve broadband infrastructure, and address social determinants of health HR 2125: Quit Because of Covid 19 Act - Would ensure that all Medicaid and CHIP enrollees have access to proven tobacco cessation treatments. HR 2347: Strengthening Vaccines for Childrens Act - Modifications to improve the Vaccine for Children (VFC) program HR 2418: Student Loan Forgiveness for Frontline Health Workers- Would forgive outstanding federal and private student loan debt for frontline physicians H.R. 5218: Collaborate in an Orderly and Cohesive Manner Act H.R. 4387/S.1675: Maternal Health Quality Improvement Act H.R. 5054: Physicians Serving Patients Act of 2021 H.R. 4770: Evaluating Disparities and Outcomes of Telehealth During the COVID-19 Emergency Act H.R. 5376: Build Back Better Act H.R. 4387/S. 1675: Maternal Health Quality Improvement Act H.R. 5218: Collaborate in an Orderly and Cohesive Manner Act H.R. 5541: Primary and Virtual Care Affordability Act S. 128: Primary Care Enhancement Act No Bill No: Physicians Serving Patients Act of 2021 No Bill No.: Congressional Primary Care Caucus;117th Congress membership in the bipartisan CPCC No Bill No.: Teaching Health Centers GME; Community Health Centers- National Health Service Corps; Special Diabetes Program; Special Diabetes Program for Indians - Increased funding and allocation of resources for teaching health center programs No Bill No.: Primary Care Patient Protection Act - Create a primary care benefit in high deductible health plans No Bill No.: No Surprise Bills for New Moms - Require health plans to cover newborns under mothers coverage for set time, SEP for enrollment post childbirth, and notification requirements No Bill No.: FY 2022 Appropriations Requests - CDC Programs (Climate/Health; Gun Violence Research; vaccine infrastructure); HRSA; AHRQ; CMS No Bill No.: Rural MOMS Act-Demonstration program to train physicians about maternal care in rural communities No Bill No.: COVID-19 Safe Birthing Act-Expand maternal telehealth for Medicaid beneficiaries; Medicaid/CHP post-partum coverage extension to one year No Bill No.: Anti-Racism in Public Health Act-Direct CDC to declare racism a public health crisis; establish a CDC-based center for addressing violence prevention No Bill No.: Equality Act-Provide affirmative, statutory nondiscrimination protections for LGBTQ Americans No Bill No.: Covid 19 vaccinations - Ensure Primary Care Physicians can access COVID-19 vaccines. No Bill No.: Telehealth Expansion - Preserve key telehealth flexibilities beyond COVID-19 PHE Affordable Insulin Now Act FY22 COVID-19 supplemental H.R. 7232: 9-8-8 and Parity Assistance Act Prevent Pandemics Act H.R. 7076: Supporting Children's Mental Health Care Access Act H.R. 3085: Equity in Neuroscience and Alzheimer's Clinical Trials Act H.R. 6584: Diverse and Equitable Participation in Clinical Trials Act H.R. 4122/S. 3658: REDI Act H.R. 1667: Dr. Lorna Breen Health Care Provider Protection Act S. 1893: Workforce Production Act of 2021 H.R. 7894/S.4347: Affordability is Access Act H.R. 8297: Ensuring Access to Abortion Act S.4306: Improving Access to Behavioral Health Integration Act S. 4170: Mental Health Reform Reauthorization Act H.R. 7666: Restoring Hope for Mental Health and Well-Being Act H.R. 7232: 9-8-8 and Parity Assistance Act H.R. 7076: Supporting Children's Mental Health Care Access Act S. 4408: Health and Location Data Protection Act No Bill No.: Behavioral health integration w/i primary care H.R. 5376: Inflation Reduction Act
Client expense: $746,388 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
S. 4446 - Modernizing Accelerated Approval Pathway Act of 2022; H.R. 6584 - DEPICT Act; S. 4348 - Food and Drug Administration Safety and Landmark Advancements Act of 2022; H.R. 7667 - Food and Drug Amendments of 2022; H.R. 6833 - The Continuing Resolution and Ukraine Supplemental Appropriations Act 2023, Division F - FDA User Fee Reauthorization Act of 2022; H.R. 7559 - the Prescription Information Modernization Act; Package Inserts/eLabeling Issues (H.R. 7559, Prescription Information Modernization Act of 2022).
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE