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Comment & Response |

Balancing Accelerated Approval for Drugs With Accelerated Withdrawal

Alain Braillon, MD, PhD1; David B. Menkes, MD, PhD2
[+] Author Affiliations
1Alcohol Treatment Unit, University Hospital of Amiens, Amiens, France
2Waikato Clinical School, University of Auckland, Auckland, New Zealand
JAMA Intern Med. 2016;176(4):566-567. doi:10.1001/jamainternmed.2016.0351.
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To the Editor Observing that the US Food and Drug Administration (FDA) has, since 2008, been approving more and more cancer drugs on the basis of surrogate outcomes, Drs Kim and Prasad documented the tenuous or unknown links of surrogates with overall survival in a recent article in JAMA Internal Medicine and called for enforcement of follow-up studies that are legislatively required after all such approvals.1 This concern accords with a previous analysis2 that found that postmarketing studies were performed in only two-thirds of cases and with a median delay of 4 years.


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April 1, 2016
Chul Kim, MD, MPH; Vinay Prasad, MD, MPH
1Medical Oncology Service, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
2Division of Hematology Oncology/Knight Cancer Institute, Oregon Health & Science University, Portland3Department of Public Health and Preventive Medicine, Oregon Health & Science University, Portland4Senior Scholar in the Center for Health Care Ethics, Oregon Health & Science University, Portland
JAMA Intern Med. 2016;176(4):567. doi:10.1001/jamainternmed.2016.0374.
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