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July 2016

Accelerated Drug Approval and Health Inequality

Author Affiliations
  • 1Department of Philosophy and Center for Ethics and Policy, Carnegie Mellon University, Pittsburgh, Pennsylvania
  • 2Studies of Translation, Ethics and Medicine (STREAM), Biomedical Ethics Unit, McGill University, Montréal, Quebec, Canada
JAMA Intern Med. 2016;176(7):883-884. doi:10.1001/jamainternmed.2016.2534

In the United States, there is considerable political momentum for accelerating access to novel medications. Faster access is often portrayed as increasing fairness by providing treatment options to patients who currently lack them. There has been scant attention, however, to the broader effects such proposals would have on equity within health care and research.

The most important product of the drug development process is the evidence base about how to use potential new medications. This evidence base also informs further research.1 This information includes which patients to treat, at what dose, and with what other treatments. It also includes estimates of the benefits and risks of appropriate use of the drug. Approving medications with data from fewer patients or patient-years of exposure diminishes this information base and increases the remaining uncertainty about benefits, risks, and use of a new medication. The costs and burdens of this additional uncertainty are unequally distributed in 4 ways.

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