Comments and Letters

Pharmaceutical Innovators are Concerned Over Not Enough Advice Meetings Being Offered in 2025 for Trial Designs and Evidence Generation Plans

Statement

December 2024

137 Organizations Urge Congress to Pass Bills to Support Rare Disease Patients

Letter

November 2024

ARM Comments on the FDA's Draft Guidance Titled 'Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies; Draft Guidance for Industry'

Comments

September 2024

ARM's Comments on the CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule

Comments

September 2024

ARM's Comments on the CY 2025 Medicare Physician Fee Schedule Proposed Rule Proposed Rule

Comments

September 2024

ARM's Comments on the FDA's Draft Guidance Titled 'Platform Technology Designation Program for Drug Development'

Comments

August 2024

ARM's Response to Representative's DeGette and Buschon RFI on the 21st Century Cures Initiative

Letter

August 2024

ARM Comments on the FDA's Draft Guidance Titled 'Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products'

Comments

July 2024

ARM Comments on the FDA's Draft Guidance Titled 'Considerations for the Use of Human-and Animal-Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products'

Comments

July 2024

Letter in Support of HR 766: The Preventive Health Savings Act

Letter

June 2024

ARM Response to FY 2025 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule

Letter

June 2024

ARM's Comments on the EMA's 'Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials'

Comments

May 2024

ARM Comments on the FDA's Draft Guidance Titled 'Potency Assurance for Cellular and Gene Therapy Products'

Comments

March 2024

ARM's Response to the House Committee on Education and the Workforce's RFI on ERISA's 50th Anniversary

Letter

March 2024

ARM Comments on the FDA's Draft Guidance Titled 'Advanced Manufacturing Technologies Designation Program – Guidance for Industry'

Comments

March 2024

ARM's Letter to CMS on Cross-State Credentialling

Letter

March 2024

ARM Comments on the FDA's Draft Report and Plan on Best Practices for Guidance

Comments

March 2024

ARM Written Testimony to House Energy and Commerce Committee for the Hearing Titled "Legislative Proposals to Support Patients with Rare Diseases"

Letter

February 2024

ARM's Letter to the Co-Sponsors of the Creating Hope Reauthorization Act of 2024

Letter

February 2024

ARM Comments on the FDA's Draft Guidance on the Advanced Manufacturing Technologies Designation Program

Comments

February 2024

ARM Comments to FDA-2023-D-4974 for Advanced Manufacturing Technologies Designation

Comments

February 2024

Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights

Comments

February 2024

ARM Response to the Solicitation of Proposals for New and Modified Safe Harbors and Special Fraud Alerts

Comments

February 2024

ARM's Response to Senator Cassidy’s Request for Information (RFI) on Ensuring Access to Gene Therapies

Letter

January 2024

Comments on FDA Draft Guidance on Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence

Comments

December 2023

ARM Comments for FDA-2023-D-2318 for Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence

Comments

December 2023

ARM's Comments on the FDA's Draft Guidance Titled 'Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products'

Comments

November 2023

ARM Comments on FDA Draft Guidance CGT Comparability

Comments

November 2023

ARM Comments on the FDA's Request for Information on Scientific Challenges and Opportunities to Advance the Development of Individualized Cellular and Gene Therapies

Comments

November 2023

ARM comments to FDA-2022-D-2629 for Post Marketing Approaches

Comments

October 2023

ARM's Letter to the Co-Sponsors of the Accelerating Kids' Access to Care Act

Comments

September 2023

ARM Comments to FDA-2023-D-0559 for Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act

Comments

September 2023

ARM's Comments on the FDA's Draft Guidance Titled 'Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act'

Comments

September 2023

CY 2024 Medicaid Physician Fee Schedule Proposed Rule

Comments

September 2023

ARM Letter to Sponsors of MVP Act

Letter

August 2023

ARM Letter to House Ways and Means Committee on NTAP

Letter

August 2023

ARM Letter to Energy and Commerce Committee on Medicaid Priorities

Letter

August 2023

Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program

Comments

July 2023

ARM's Comments on the FDA's Draft Guidance Titled 'Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments lnto Endpoints for Regulatory Decision-Making'

Comments

June 2023

ICER’s 2023 Value Assessment Framework Proposed Changes

Comments

June 2023

ARM Comments to FDA-2023-D-0026 for Patient-Focused Drug Development

Comments

June 2023

Proposed Rule on Ensuring Access to Medicaid Services

Comments

June 2023

Proposed Rule on Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality

Comments

June 2023

Proposed Hospital Inpatient Prospective Payment Systems

Comments

June 2023

Summary of ARM's Comments During the FDA's Listening Session on 'Methods and approaches for capturing post-approval safety and efficacy data on cell and gene therapy products'

Comments

May 2023

ARM's Comments on the FDA's Draft Guidance Titled 'Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics'

Comments

May 2023

ARM Comments to FDA-2023-D-0110 for Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics

Comments

May 2023

CMS Discarded Drug Refund Policy

Comments

February 2023

ARM Comments on the FDA's Patient Focused Drug Development Public Meeting

Comments

December 2022

CMS proposed payment updates to 2023 Medicare Physician Fee Schedule

Comments

September 2022

Medicaid and CHIP Payment and Access Commission

Letter

March 2021

ARM's Comments on Comments to ICER's Draft Evidence Report on Anti B-Cell Maturation Antigen CAR T-cell and Antibody Conjugate Therapy for Heavily Pre-Treated Relapsed and Refractory Multiple Myeloma

Comments

March 2021

ARM's Comments on the Beat Cancer Plan

Comments

February 2021

ARM's Letter to the House Innovation Caucus

Letter

January 2021

ARM's Letter to the WHO on Gene Editing

Letter

January 2021

ARM and BIO's Letter in Support of ICD for Intravenous Infusion of Approved CAR-T Therapies

Letter

November 2021

Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘‘Reasonable and Necessary’

Comments

November 2020

“Independent Third-Party Assessment of Investigational New Drug Food and Drug Administration-Sponsor Communication Practices in Prescription Drug User Fee Act VI;

Comments

September 2020

ARM Comments on the Reauthorization of the Prescription Drug User Fee Act

Comments

August 2020

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals

Comments

July 2020

Comments for FDA Docket Number: FDA-2019-D-5392; Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations;

Comments

July 2020

CMS Proposed Rule on Value-Based Purchasing for Drugs Covered in Medicaid, CMS2482-P

Comments

July 2020

CMS: Charges for CAR T-cell therapies

Letter

March 2020

FDA: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry

Comments

March 2020

CMS RFI: Coordinating Care from Out-of-State Providers for Medicaid Eligible Children with Medically Complex Conditions

Comments

March 2020

US House of Representatives: Cures 2.0 Initiative

Letter

December 2019

Request for MS-DRG CMS: Reclassification for Certain Cases Involving Use of Chimeric Antigen Receptor T-Cell Therapies

Joint Letter

November 2019

White House Office of Science and Technology Policy: U.S. Bioeconomy

Comments

October 2019

Michigan State Legislature: Proposed New Standard for Immune Effector Cell Therapy (IECT) Services

Letter

October 2019

ICER RFI: 2020 Value Assessment Framework

Comments

October 2019

ICER: Proposed Methods Adaptations for Assessments of Potential Cures and Other Transformative Therapies

Comments

September 2019

MI DOCH: Certificate of Need (CON) Program: Proposed New Standard for Immune Effector Cell Therapy (IECT) Services

Comments

July 2019

EMA: Public consultation on the EMA's Regulatory Science to 2025 document

Questionnaire

June 2019

EMA: Submission of comments on 'Discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations'

Comments

July 2019

CMS: HIPPS for FY 2020; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals

Comments

June 2019

HHS: OIG Proposed Rule on the Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees

Comments

April 2019

FDA Draft Guidance: "Rare Diseases: Common Issues in Drug Development"

Comments

April 2019

CMS NCA Decision for CAR-T Therapies: Coverage with Evidence Development for CAR T-Cell Therapy

Comments

March 2019

ICER RFI: Evaluation of Potentially Curative Treatments and for Translating the Results of Cost-Effectiveness Analyses into Recommendations for Value-Based Price Benchmarks

Comments

February 2019

FDA Framework: "Framework for a Real-World Evidence Program"

Comments

February 2019

CMS: Trump Administration Proposal Regarding International Pricing Index Model for Medicare Part B Drugs

Comments

December 2018

FDA's Draft Guidance: “Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings"

Comments

December 2018

FDA Draft Guidances: Six Guidances for Human Gene Therapy

Comments

December 2018

CMS Town Hall Meeting: FY 2020 IPPS New Technology Add-on Payment Program

Comments

December 2018

European Commission: GMO Requirements for Gene Therapies

Letter

October 2018

HHS OIG RFI: Anti-Kickback Statute and Value-Based Payment Models

Comments

October 2018

NIH: "Recombinant or Synthetic Nucleic Acid Research: Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules"

Comments

October 2018

CMS RFI: Competitive Acquisition Program for Part B Drugs and Biologicals for a Potential CMS Innovation Center Model

Comments

September 2018

EMA Draft Guidance: "Guideline on Sponsor Responsibilities in Handling & Shipping IMPs"

Comments

August 2018

House of Representatives’ Health Care Innovation Caucus RFI: Value-Based Payment Reform

Comments

August 2018

EMA Draft Guidance: "Guideline on Safety and Efficacy Follow-Up and Risk Management of ATMPs"

Comments

August 2018

FDA: Guiding Principles to Determining Approaches to Disease-Specific Guidances

Letter

August 2018

HHS RFI: Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs

Comments

July 2018

Proposal for a Regulation of the European Parliament and of the Council on Health Technology Assessment and Amending Directive 2011/24/EU (COM(2018) 51 final)

Statement

July 2018

CMS National Coverage Analysis: CAR-T Cell Therapies

Comments

June 2018

CMS Proposed IPPS Rule FY 2020: New Technology Add-On Payment Program

Comments

June 2018

EMA Draft Guidance: "Guideline on Safety and Efficacy Follow-Up and Risk Management of Advanced Therapy Medicinal Products"

Comments

March 2018

FDA Draft Guidance: "Evaluation of Devices Used with Regenerative Medicine Advanced Therapies"

Comments

February 2018

FDA Draft Guidance: "Response to Expedited Programs for Regenerative Medicine Therapies for Serious Conditions"

Comments

February 2018

FDA: Announcement Regarding Guidance to Foster Development of Gene Therapies

Letter

March 2018

FDA Draft Guidance: “Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products”

Comments

March 2018

HHS OIG: Anti-Kickback Safe Harbor for Value-Based Purchasing Arrangements

Comments

February 2018

CMS Town Hall: New Technology Add-On Payment Program

Comments

February 2018