RAPID Reserve Act

Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Generic Drug Reporting Requirement Language in Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. Public Law No. 119-60: National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062: RAPID Reserve Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. S.1414/H.R.__: Expedited Access to Biosimilars Act. S.3469: BIOSECURE Act of 2025. Quotas on Controlled Substances. Hassan Purple Book Proposal. S.3788: Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act. PBM Bid Transparency. H.R.7148 - Consolidated Appropriations Act, 2026 as it relates to PBM reforms and Q1/Q2.

Client expense: $840,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the Consolidated Appropriations Act, 2026 (PL 119-75); Issues related to the National Defense Authorization Act for Fiscal Year 2026 (PL 119-60); Issues related to H.R. 4191/S. 1784 - MAPS Act; Issues related to H.R. 3955/S. 2062 - RAPID Reserve Act.

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

-Support for the RAPID Reserve Act (S 2062/HR 3955), which aims to address drug shortages by awarding federal contracts to American-based manufacturers of generic drugs to encourage domestic production of these critical medications as well as incentivize them to increase their reserves in preparation for possible future public health threats or supply chain challenges and ramp up their production capacity if necessary to proactively prevent shortages. -Support for the Mapping Americas Pharmaceutical Supply or MAPS Act (S 1784/HR 4191), which seeks conduct a risk assessment and supply chain map of all essential medicines to help identify vulnerabilities and potential national security risks. -Support for the Drug Shortages Prevention Act (S 2665), which would have required manufacturers to notify the FDA of heightened demand for crucial medicines that could lead to shortages -Support for the reintroduction of the following bill from the 118th Congress: The Drug Shortages Prevention and Quality Improvement Act, which aimed to implement reimbursement models to incentivize the production of generic injectables and extend expiration dates for lifesaving medications -Comments in response to the notice of proposed rulemaking (ANPRM) Ensuring Safety Through Domestic Security With Made in America Personal Protective Equipment (PPE) and Essential Medicine Procurement by Medicare Participating Hospitals. -Encouraging congressional assistance to seek information from the Defense Health Agency, which administers the Tricare program, on the rates used to reimburse participating providers in the TRICARE Active Duty Dental Program (ADDP). -Support for FY 2027 appropriations for the Dr. Lorna Breen Health Care Provider Protection Act. -Support for the Alternatives to Prevent Addiction in the Nation Act (H.R. 1227), which would reduce cost-sharing and prohibits the imposition of certain utilization requirements under the Medicare prescription drug benefit for certain non-opioid pain management drugs. -Urging CMS to communicate to Part D plan sponsors about the clinical importance of FDA-approved, clinically appropriate non-opioid acute pain treatment options and encourage appropriate formulary coverage ensuring beneficiary access to such approaches.

H.R. 6423/S. 864: HELP Copays Act - requires health insurers to count third-party financial assistance toward patients' cost-sharing obligations, including deductibles and copays, for prescription drugs, with changes effective for plan years beginning January 1, 2026. S. 526: PBM Transparency Act - prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs H.R. 1262/S. 932: Mikaela Naylon Give Kids a Chance Act of 2025 - To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. HR 929/S.266: Dr. Lorna Breen Health Care Provider Protection Reauthorization Act - To reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, and for other purposes. H.R. 4191/S. 1784: MAPS Act - requires federal agencies to regularly update a list of essential medicines, assess and report on supply chain risks, map pharmaceutical supply chains, and enhance coordination and cybersecurity to protect public health and national security. H.R. 3955/S.2062: RAPID Reserve Act - establishes a $500 million program to create and maintain domestic reserves of critical drugs and their ingredients, prioritizing domestic manufacturing and supply chain resilience to prevent shortages during public health emergencies. S. 1954: Biosimilar Red Tape Elimination Act - streamlines the approval process for biosimilar biological products by automatically deeming them interchangeable with reference products, subject to certain exclusivity protections, and requires updated regulatory guidance to reflect these changes. H.R. 4101: Cancer Drug Parity Act of 2025 - requires group health plans to provide cost-sharing for oral anticancer drugs that is at least as favorable as for provider-administered anticancer medications, with protections against increased patient costs and a mandated GAO study on the law's impact. H.R. 3521: Clinical Trials Modernization Act - Increase clinical trial participation among underrepresented populations by providing grants, permitting certain participant reimbursements, and offering tax exclusions, while ensuring compliance with existing legal protections. S. 705: Innovation in Pediatric Drugs Act of 2025 - amends existing laws to enhance pediatric cancer research, mandates compliance measures, allocates funding for pediatric studies, and sets guidelines for orphan drugs, with specific timelines for implementation and evaluation. H.R. 5509/S. 2903: Safe Step Act - 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, and for other purposes. H.R. 4425/S. 2287: Palliative Care and Hospice Education and Training Act - expands federal support for workforce development, education, public awareness, and research in palliative and hospice care, with targeted funding and statutory changes to improve care for patients with serious or life-threatening illnesses.

Support for the RAPID Reserve Act (S 2062/HR 3955), which aims to address drug shortages by awarding federal contracts to American-based manufacturers of generic drugs to encourage domestic production of these critical medications as well as incentivize them to increase their reserves in preparation for possible future public health threats or supply chain challenges and ramp up their production capacity if necessary to proactively prevent shortages. Support for the Mapping Americas Pharmaceutical Supply or MAPS Act (S 1784/HR 4191), which seeks conduct a risk assessment and supply chain map of all essential medicines to help identify vulnerabilities and potential national security risks. Support for the reintroduction of the following drug and supply bills from the 118th Congress: The Drug Shortages Prevention and Quality Improvement Act, which aimed to implement reimbursement models to incentivize the production of generic injectables and extend expiration dates for lifesaving medications and the Drug Shortages Prevention Act, which would have required manufacturers to notify the FDA of heightened demand for crucial medicines that could lead to shortages. Encouraging congressional assistance to seek information from the Defense Health Agency, which administers the Tricare program, on the rates used to reimburse participating providers in the TRICARE Active Duty Dental Program (ADDP).

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

H.R. 6423/S. 864: HELP Copays Act - requires health insurers to count third-party financial assistance toward patients' cost-sharing obligations, including deductibles and copays, for prescription drugs, with changes effective for plan years beginning January 1, 2026. S. 526: PBM Transparency Act - prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs H.R. 1262/S. 932: Give Kids a Chance Act of 2025 - To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. HR 929/S.266: Dr. Lorna Breen Health Care Provider Protection Reauthorization Act - To reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, and for other purposes. H.R. 4191/S. 1784: MAPS Act - requires federal agencies to regularly update a list of essential medicines, assess and report on supply chain risks, map pharmaceutical supply chains, and enhance coordination and cybersecurity to protect public health and national security. H.R. 3955/S.2062: RAPID Reserve Act - establishes a $500 million program to create and maintain domestic reserves of critical drugs and their ingredients, prioritizing domestic manufacturing and supply chain resilience to prevent shortages during public health emergencies. S. 1954: Biosimilar Red Tape Elimination Act - streamlines the approval process for biosimilar biological products by automatically deeming them interchangeable with reference products, subject to certain exclusivity protections, and requires updated regulatory guidance to reflect these changes. H.R. 4101: Cancer Drug Parity Act of 2025 - requires group health plans to provide cost-sharing for oral anticancer drugs that is at least as favorable as for provider-administered anticancer medications, with protections against increased patient costs and a mandated GAO study on the law's impact. H.R. 3521: Clinical Trials Modernization Act - Increase clinical trial participation among underrepresented populations by providing grants, permitting certain participant reimbursements, and offering tax exclusions, while ensuring compliance with existing legal protections. S. 705: Innovation in Pediatric Drugs Act of 2025 - amends existing laws to enhance pediatric cancer research, mandates compliance measures, allocates funding for pediatric studies, and sets guidelines for orphan drugs, with specific timelines for implementation and evaluation. H.R. 5509/S. 2903: Safe Step Act - 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, and for other purposes. H.R. 4425/S. 2287: Palliative Care and Hospice Education and Training Act - expands federal support for workforce development, education, public awareness, and research in palliative and hospice care, with targeted funding and statutory changes to improve care for patients with serious or life-threatening illnesses.

Issues related to H.R. 5304/S. 2587 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026; Issues related to H.R. 4016/S. 2572 - Department of Defense Appropriations Act, 2026; Issues related to the National Defense Authorization Act for Fiscal Year 2026 (PL 119-60); Issues related to H.R. 4191/S. 1784 - MAPS Act; Issues related to H.R. 3955/S. 2062 - RAPID Reserve Act.

Client expense: Not reported · Firm income: $90,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. Generic Drug Reporting Requirement Language in the Senate NDAA, S.2296 - National Defense Authorization Act for Fiscal Year 2026. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. H.R.5526/S.1954: Biosimilar Red Tape Elimination Act (BRTEA). H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062: RAPID Reserve Act. H.R.4191/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025. Establishment Inspection Reports. S.1414/H.R._: Expedited Access to Biosimilars Act.

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

S. 864: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes. S. 526: PBM Transparency Act - prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs H.R. 1262/S. 932: Give Kids a Chance Act of 2025 - To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. HR 929/S.266: Dr. Lorna Breen Health Care Provider Protection Reauthorization Act - To reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, and for other purposes. H.R. 4191/S. 1784: MAPS Act - requires federal agencies to regularly update a list of essential medicines, assess and report on supply chain risks, map pharmaceutical supply chains, and enhance coordination and cybersecurity to protect public health and national security. H.R. 3955/S.2062: RAPID Reserve Act - establishes a $500 million program to create and maintain domestic reserves of critical drugs and their ingredients, prioritizing domestic manufacturing and supply chain resilience to prevent shortages during public health emergencies. S. 1954: Biosimilar Red Tape Elimination Act - streamlines the approval process for biosimilar biological products by automatically deeming them interchangeable with reference products, subject to certain exclusivity protections, and requires updated regulatory guidance to reflect these changes. H.R. 4191: To improve coordination of Federal efforts to identify and mitigate health and national security risks through maintaining a list of essential medicines, conducting a risk assessment of essential medicine supply chains, and creating a monitoring system to map essential medicine supply chains using data analytics. H.R. 4101: Cancer Drug Parity Act of 2025 - requires group health plans to provide cost-sharing for oral anticancer drugs that is at least as favorable as for provider-administered anticancer medications, with protections against increased patient costs and a mandated GAO study on the law's impact. H.R. 3521: Clinical Trials Modernization Act - Increase clinical trial participation among underrepresented populations by providing grants, permitting certain participant reimbursements, and offering tax exclusions, while ensuring compliance with existing legal protections. S. 705: Innovation in Pediatric Drugs Act of 2025 - amends existing laws to enhance pediatric cancer research, mandates compliance measures, allocates funding for pediatric studies, and sets guidelines for orphan drugs, with specific timelines for implementation and evaluation. H.R. 5509/S. 2903: Safe Step Act - 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, and for other purposes. H.R. 4425/S. 2287: Palliative Care and Hospice Education and Training Act - expands federal support for workforce development, education, public awareness, and research in palliative and hospice care, with targeted funding and statutory changes to improve care for patients with serious or life-threatening illnesses. Cures 2.1

Support for the RAPID Reserve Act (S 2062/HR 3955), which aims to address drug shortages by awarding federal contracts to American-based manufacturers of generic drugs to encourage domestic production of these critical medications as well as incentivize them to increase their reserves in preparation for possible future public health threats or supply chain challenges and ramp up their production capacity if necessary to proactively prevent shortages. Support for the Mapping Americas Pharmaceutical Supply or MAPS Act (S 1784/HR 4191), which seeks conduct a risk assessment and supply chain map of all essential medicines to help identify vulnerabilities and potential national security risks. Support for the reintroduction of the following drug and supply bills from the 118th Congress: The Drug Shortages Prevention and Quality Improvement Act, which aimed to implement reimbursement models to incentivize the production of generic injectables and extend expiration dates for lifesaving medications. Suggestions for deregulation within federal healthcare programs, specifically the request to Rescind Limitations on Notice and Consent Waivers for Non-Emergency Services under the No Surprises Act and to Streamline or Eliminate the Merit-based Incentive Payment System (MIPS). Comments to CMS expressing concern about implementation of the Non-Opioids Prevent Addiction in the Nation ("NOPAIN") Act as provided for in the CY 2026 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule. Support for HR 4556, the the Protect Our Treatment for Enamel, Erosion, and Tooth Health (TEETH Act), which would require the Environmental Protection Agency (EPA) to commission an independent, rapid-response evidence review from the National Academies of Sciences, Engineering, and Medicine before proposing updates to drinking water regulations that affect community water fluoridation.

Prescription Drug Costs. H.R.1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. S.1302: Increasing Transparency in Generic Drug Applications Act. H.R.1396/S.1891: Producing Incentives for Long-term Production of Lifesaving Supply of Medicine (PILLS) Act. Drug Shortages. S.1954: Biosimilar Red Tape Elimination Act. H.R.1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. American Relief Act, 2025 (PL. No: 118-158) as it relates to Patent Thickets and Q1/Q2. H.R.3955/S.2062 - RAPID Reserve Act. H.R.6992/S.1784: Mapping Americas Pharmaceutical Supply (MAPS) Act. H.R.4132/S.2027: Prescription Information Modernization Act of 2025.

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

H.R. 247/ S. 46, Health Care Affordability Act H.R 1650/S. 763, Telehealth Expansion Act H.R.2213/S.988, Medical Supply Chain Resiliency Act H.R. 3170, the Improving Access to Workers Compensation for Injured Federal Workers Act H.R.3955/S.2062, Modified Rolling Active Pharmaceutical Ingredient and Drug (RAPID) Reserve Act Department of Commerce, Bureau of Industry and Security Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients (BIS-2025-0022) Department of Health and Human Services Advancing Health through Prevention, Chronic Care, and Healthy Living, MAHA Commission Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again Request for Information (AHRQ-2025-0001) Centers for Medicare and Medicaid Services Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability Proposed Rule (CMS-9884-P) Health Technology Ecosystem Request for Information (CMS-0042-NC)

Client expense: $180,000 · Firm income: Not reported

S. 864: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes. S. 526: PBM Transparency Act - prevents unfair and deceptive acts or practices and the dissemination of false information related to pharmacy benefit management services for prescription drugs H.R. 1262/S. 932: Give Kids a Chance Act of 2025 - To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. HR 929/S.266: Dr. Lorna Breen Health Care Provider Protection Reauthorization Act - To reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, and for other purposes. S. 1784: MAPS Act - requires federal agencies to regularly update a list of essential medicines, assess and report on supply chain risks, map pharmaceutical supply chains, and enhance coordination and cybersecurity to protect public health and national security. H.R. 3955/S.2062: RAPID Reserve Act - establishes a $500 million program to create and maintain domestic reserves of critical drugs and their ingredients, prioritizing domestic manufacturing and supply chain resilience to prevent shortages during public health emergencies. S. 1954: Biosimilar Red Tape Elimination Act - streamlines the approval process for biosimilar biological products by automatically deeming them interchangeable with reference products, subject to certain exclusivity protections, and requires updated regulatory guidance to reflect these changes. H.R. 4191: To improve coordination of Federal efforts to identify and mitigate health and national security risks through maintaining a list of essential medicines, conducting a risk assessment of essential medicine supply chains, and creating a monitoring system to map essential medicine supply chains using data analytics. H.R. 4101: Cancer Drug Parity Act of 2025 - requires group health plans to provide cost-sharing for oral anticancer drugs that is at least as favorable as for provider-administered anticancer medications, with protections against increased patient costs and a mandated GAO study on the law's impact. H.R. 3521: Clinical Trials Modernization Act - establishes a new payment program for radiation oncology services, focusing on stable payments, quality care, and patient access, while exempting it from budget neutrality adjustments. S. 705: Innovation in Pediatric Drugs Act of 2025 - amends existing laws to enhance pediatric cancer research, mandates compliance measures, allocates funding for pediatric studies, and sets guidelines for orphan drugs, with specific timelines for implementation and evaluation. Cures 2.1

Support for the RAPID Reserve Act (S 2062/HR 3955), which aims to address drug shortages by awarding federal contracts to American-based manufacturers of generic drugs to encourage domestic production of these critical medications as well as incentivize them to increase their reserves in preparation for possible future public health threats or supply chain challenges and ramp up their production capacity if necessary to proactively prevent shortages. Support for the Mapping Americas Pharmaceutical Supply or MAPS Act (S 1784/HR 4191), which seeks conduct a risk assessment and supply chain map of all essential medicines to help identify vulnerabilities and potential national security risks. Support for the reintroduction of the following drug and supply bills from the 118th Congress: The Drug Shortages Prevention and Quality Improvement Act, which aimed to implement reimbursement models to incentivize the production of generic injectables and extend expiration dates for lifesaving medications. Support for legislation to reauthorize the Dr. Lorna Breen Health Care Provider Protection Act (H.R. 929/S. 266), which provides funding for programs that support mental healthcare for healthcare providers. Ask the DOD to maintain current water fluoridation levels on overseas bases. Suggestions for deregulation within federal healthcare programs. Support for the Alternatives to Prevent Addiction in the Nation (Alternatives to PAIN) Act (H.R. 1227/S. 475)

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