CoChat
Sign Up
Cited by 7Biomedical Ethics and RegulationGenetics, Aging, and Longevity in Model OrganismsPharmaceutical Economics and Policy

The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index.

A Regulatory Pathway for Medicines That Target Aging

Fleming, G Alexander, Zhao, Jennifer H, Seoh, Thomas C, Barzilai, Nir·2019·Public Policy & Aging Report
DOI 10.1093/ppar/prz018
Open this paper in CoChat — free account

Abstract

With the world’s population growing older and the primary causes of death shifting to noncommunicable, chronic diseases, there is a high unmet need for interventions that delay or prevent chronic disease. The emerging science of biological aging (geroscience) has demonstrated the feasibility of slowing biological aging, delaying chronic diseases, and spending more time living free from chronic disease, also known as increasing the “healthspan.” Despite these scientific advances, the Food and Drug Administration (FDA) and other major authorities have not articulated a regulatory pathway for licensing products with age-related claims. Regulation of the development of medicines has traditionally focused on the treatment of specific diseases and functional impairments. The perception is that a gap is expanding between what science may offer as age-related interventions and what drug regulation can provide in response. An approach that is consistent with FDA policy and practice is exemplified by the primary efficacy endpoint and proposed analysis of the Targeting Aging with Metformin (TAME) trial. Efficacy in this trial has been defined by reducing the time to the first occurrence of any one of several chronic diseases. This approach avoids the daunting challenges of defining the aging process and validating measures to assess it. In essence, TAME aims to show a positive effect on the measure of healthspan, which is defined as the period of life or length of time spent in the absence of any major, age-related disease (Barzilai, Crandall, Kritchevsky, & Espeland, 2016; Kaeberlein, 2018). Instead of making aging a disease, the focus is on delaying or preventing chronic diseases in aging. To expedite the translation of emerging science into material gains in public health, innovations are needed in other domains: clinical investigation, health-care economics, and commercialization. Extending healthspan and changing the emphasis from disease management to disease prevention represent two of the most important challenges and opportunities for patients and would-be non-patients, their quality of life, and societal economics in this century.

Overview

Integrity signals

Registry

Crossref · 10.1093/ppar/prz018

Cites

24 of 24 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Citations

Cites

Flagged first, then by citations

Research works printed but not linked: 6

  1. American Federation for Aging Research., ., TAME trial
  2. Life Biosciences, ., The entirety of healthspan research
  3. National Institutes of Health, 2016, World’s older population grows dramatically
  4. Strategies for Engineered Negligible Senescence (SENS) Research Foundation., ., A reimagined research strategy for aging.
  5. Tournas, 2019, The fountain of youth revisited: Regulatory challenges and pathways for healthspan promoting interventions, Food and Drug Law Journal, 74, 18
  6. U.S. Food and Drug Administration, 2018, Development & approval process (Drugs)

Cited by

Sorted by citations

Related

Metadata

Authors
Fleming, G. A., Zhao, J. H., Seoh, T. C., & Barzilai, N.
Affiliations
  • Kinexum, Harpers Ferry, WV
  • Albert Einstein College of Medicine (US)
Corresponding author
Fleming, G Alexander
ORCID
Venue
Public Policy & Aging Report
Publisher
Oxford University Press (OUP)
Published
2019
Volume
29
Issue
4
Pages
128-133
ISSN
  • 1055-3037 (ISSN-L)
  • 2053-4892
DOI
10.1093/ppar/prz018
OpenAlex
W2974578638
Cited by
7
References
23
Citations by year
2026: 1 · 2025: 3 · 2022: 1 · 2021: 1 · 2020: 1
FWCI
1.15
Type
journal article
Language
en
Open access
closed
Licence
academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor, 260 d)
Locations
Public Policy & Aging Report (publishedVersion)
Topics
  • Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Aging › Genetics, Aging, and Longevity in Model Organisms
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
Keywords
drug regulation, geroscience, biological aging, healthspan, chronic disease prevention, metformin, FDA regulatory policy, drug approval, disease prevention

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review