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Title page 1

Contents 3

Highlights 2

Letter 5

Background 10

ALS Disease and Drug Development 10

Clinical Trials 12

FDA's Expanded Access Pathway 14

NIH's Expanded Access Grants 17

Most NIH and FDA Funding to Implement the ACT for ALS Act Supported ALS Research and Access to ALS Investigational Drugs 18

NIH Funding for Research and Access to ALS Investigational Drugs 18

NIH and FDA Funding for Research Coordination Through the Public-Private Partnership 22

FDA Funding for Rare Neurodegenerative Disease Research Priorities 24

NIH and FDA Identified Challenges Stemming from Funding Timing and Requirements and Took Actions to Address Challenges Within Their Control 26

Shortened Time frames for Agencies to Award Funding 26

Availability of Appropriations for FDA to Implement the Act 28

Eligibility Requirements for Expanded Access Grants 29

Review Requirements for Expanded Access Grant Applications 30

Stakeholders and Literature Indicated Potential Benefits of NIH and FDA Funding for Ongoing Research and ALS Investigational Drugs 31

Current and Potential Benefits of NIH Funding for Research and Access to ALS Investigational Drugs 32

Current and Potential Benefits of NIH and FDA Funding for Research Coordination Through the Public-Private Partnership 37

Current and Potential Benefits of FDA Funding for Rare Neurodegenerative Disease Research Priorities 39

Agency Comments 42

Appendix I: Profiles of NIH Grants 43

Appendix II: FDA Grants and Contracts 47

Appendix III: Clinic Sites Participating in Expanded Access Programs Before and After the ACT for ALS Act 54

Appendix IV: GAO Contact and Staff Acknowledgments 58

Tables 3

Table 1. Summary of Expanded Access Grants Awarded by the National Institutes of Health (NIH) Fiscal Years (FY) 2022 through 2025... 19

Table 2. Summary of Grants and Contracts Awarded by Food and Drug Administration (FDA) from Fiscal Years (FY) 2022 through 2025... 25

Table 3. Clinic Sites Participating in Expanded Access Grants and Expanded Access Programs for Individuals with Amyotrophic Lateral... 55

Figures 4

Figure 1. Timeline of ALS Diagnosis and Disease Progression with Optimal Clinical Trial Participation 13

Figure 2. Clinical Trial Process and FDA's Expanded Access Pathway 16

Figure 3. Map of Clinic Sites Associated with the Expanded Access Grants, as of August 2025 20

Figure 4. Profiles of Five Expanded Access Grants Awarded by the National Institutes of Health, by Investigational Drug 44

Figure 5. Rare Neurodegenerative Disease Grant Program Grants and Contracts Related to Amyotrophic Lateral Sclerosis (ALS)... 48

Figure 6. Rare Neurodegenerative Disease Grant Program Grants Related to Other Rare Neurodegenerative Diseases Awarded Fiscal Years 2022 Through 2025 51

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