Hastings Center Report 47 (2):16-20 (2017)

Spencer Hey
Harvard University
Many hold that the so-called golden era of antibiotic discovery has passed, leaving only a limited clinical pipeline for new antibiotics. A logical conclusion of such arguments is that we need to reform the current system of antibiotic drug research—including clinical trials and regulatory requirements—to spur activity in discovery and development. The United States Congress in the past few years has debated a number of bills to address this crisis, including the 2012 Generating Antibiotic Incentives Now Act and the 2016 21st Century Cures Act. Experts have also sought to advance antibiotic development by encouraging greater use of trials with noninferiority hypotheses, which are thought to be easier to conduct. The goal underlying these proposals is to stave off the post-antibiotic era by expanding the pharmaceutical armamentarium as quickly as possible. But although new antibiotic agents are necessary to combat the long-term threat of drug-resistant disease, we argue that these research policies, which effectively lower the bar for antibiotic approval, are ethically problematic. Rather, given broader public health considerations related to the full lifecycle of antibiotic use—including development of resistance—we should reject an overly permissive approach to new antibiotic approval and instead set the bar for regulatory approval at a point that will naturally direct research resources toward the most transformative chemical or social interventions.
Keywords No keywords specified (fix it)
Categories (categorize this paper)
DOI 10.1002/hast.685
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

PhilArchive copy

Upload a copy of this paper     Check publisher's policy     Papers currently archived: 72,634
External links

Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
Through your library

References found in this work BETA

Just Health Care.Cheyney Ryan - 1990 - Philosophical Review 99 (2):287.

Add more references

Citations of this work BETA

Property Claims on Antibiotic Effectiveness.Cristian Timmermann - 2021 - Public Health Ethics 14 (3):256–267.

Add more citations

Similar books and articles

Antibiotic Resistance Due to Modern Agricultural Practices: An Ethical Perspective. [REVIEW]Joan Duckenfield - 2013 - Journal of Agricultural and Environmental Ethics 26 (2):333-350.
Ethics, Science, and Antimicrobial Resistance.Bernard Rollin - 2001 - Journal of Agricultural and Environmental Ethics 14 (1):29-37.


Added to PP index

Total views
17 ( #641,687 of 2,533,811 )

Recent downloads (6 months)
1 ( #388,784 of 2,533,811 )

How can I increase my downloads?


My notes