A. Proposed Bill to Establish a Special Regulatory Category for Aging Interventions
Table of Contents
Title and Preamble: States the short title of the act and outlines its purpose—to establish a dedicated regulatory pathway for interventions targeting aging and age‐related decline to foster innovation and public health.
Definitions: Provides clear definitions for key terms such as “aging interventions,” “gerotherapeutics,” “biomarker system,” “healthspan,” “post‐market surveillance,” and other technical terms used throughout the bill.
Establishment of the Special Regulatory Category: Creates a new regulatory category within the Food, Drug, and Cosmetic framework specifically for aging interventions, detailing its scope and jurisdiction.
Criteria for Approval: Sets forth the scientific and clinical criteria—including validated biomarker systems and evidence from preclinical and clinical studies—that interventions must meet to be classified under this category.
Clinical Development and Trial Design Requirements: Outlines the required standards for clinical trials, including recommended endpoints, surrogate markers, patient subgroup representation, and trial designs tailored for aging interventions.
Manufacturing, Quality Control, and Safety Standards: Specifies good manufacturing practices (GMP) and quality assurance protocols, including risk–benefit analyses and safety monitoring requirements.
Post-Market Surveillance and Reporting: Details requirements for ongoing monitoring, adverse event reporting, and periodic reassessment of the intervention’s safety and efficacy after market approval.
Regulatory Flexibility and Expedited Review: Provides provisions for accelerated review processes, conditional approvals, and flexible labeling to account for the unique challenges of aging research.
Intellectual Property, Data Exclusivity, and Incentives: Establishes measures to protect intellectual property and grant market exclusivity or financial incentives to encourage innovation in geroscience.
Funding and User Fee Provisions: Authorizes appropriations and establishes fee structures to support the new review pathway while ensuring that funding does not compromise regulatory integrity.
Implementation and Transition Provisions: Sets a timeline and transitional rules for existing products and new applications, ensuring a smooth shift into the new regulatory framework.
Enforcement, Penalties, and Remedies: Outlines the enforcement mechanisms and penalties for non-compliance, as well as remedial actions that can be taken in cases of violations.
Reporting, Review, and Sunset Provisions: Requires periodic reporting to Congress on the pathway’s performance, mandates reviews for possible amendments, and includes sunset clauses to reassess the category’s viability.
Amendments and Repeals: Specifies how this Act interacts with existing laws and under what circumstances it can be amended or repealed.
B. Proposed Regulatory Guidance for a Special Pathway for Aging Interventions
Table of Contents
Executive Summary: Summarizes the proposal’s rationale, objectives, and key recommendations for establishing a new regulatory pathway for aging interventions.
Background and Rationale: Reviews the current challenges in evaluating aging interventions, including limitations of traditional drug approval pathways, and presents the scientific and public health rationale for a dedicated pathway.
Scope and Definitions: Clearly defines the scope of the proposed pathway and provides definitions for terms such as “aging intervention,” “gerotherapeutic,” “biomarker,” and “healthspan.”
Scientific Criteria and Biomarker System Requirements: Sets out the scientific benchmarks and validated biomarker systems required to evaluate aging interventions, drawing on current geroscience research.
Safety and Efficacy Standards: Details the preclinical and clinical evidence thresholds (including surrogate endpoints) necessary for approval, emphasizing the balance of risk versus benefit in an aging population.
Clinical Trial Design and Surrogate Endpoints: Recommends trial designs tailored for aging interventions, including strategies for patient subgroup inclusion, use of composite endpoints, and integration of real-world data.
Quality Control and Manufacturing Standards: Outlines quality assurance measures, including manufacturing protocols and adherence to Good Manufacturing Practices (GMP), specific to interventions aimed at aging.
Risk-Benefit Analysis Framework: Proposes a structured framework for evaluating the overall risk–benefit profile of aging interventions, incorporating long-term and post-market data.
Post-Market Surveillance and Long-Term Monitoring: Describes the requirements for ongoing monitoring, including safety reporting, periodic review of effectiveness, and updating of biomarker data post-approval.
Regulatory Pathway and Approval Process: Details the step-by-step review and approval process under the new pathway, including pre-IND meetings, expedited review options, and conditions for conditional approvals.
Advisory Committee and Expert Panel Involvement: Recommends the formation of an advisory committee or expert panel (e.g., industry archons, geroscientists, clinicians) to assist in the review process and provide ongoing scientific input.
Implementation Timeline and Transition Measures: Provides an implementation timeline and transitional provisions for existing therapies and new applications, ensuring continuity and clarity in the regulatory process.
Funding, Incentives, and Stakeholder Collaboration: Outlines potential funding mechanisms, incentive structures for innovation, and strategies for collaboration between the FDA, industry, and academic experts.
Appendices: Includes supplementary materials such as detailed case studies, scientific data summaries, stakeholder comments, and a glossary of terms.
Conclusion and Recommendations: Summarizes the proposal, reiterates its benefits for public health, and calls for formal adoption of the new pathway.
IMMORTALITY