July 8, 2013

The Complexity of Integrating Speed and Safety in Drug Development and Approval

Author Affiliations
  • 1School of Law and Department of Medical History and Bioethics, School of Medicine and Public Health, University of Wisconsin–Madison

Copyright 2013 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA Intern Med. 2013;173(13):1165-1166. doi:10.1001/jamainternmed.2013.7161

Speed and safety in the development and approval of new medications have too long been viewed as a zero-sum tradeoff. Some have called for more accelerated approval processes for drugs. Others want more robust postmarket surveillance and more aggressive actions to limit or withdraw approved drugs when appropriate. Although both views have some merit, a more comprehensive and collaborative approach is needed to better align industry incentives and patient interests. Approaches that accelerate drug approval (pharmacogenomics, biomarkers, surrogate end points, and abbreviated trials) should be integrated with postmarket measures (conditional approval, limited licensing, and limitations on direct-to-consumer advertising and off-label promotion). Because the postmarket measures may make pharmaceutical investments less profitable, new financial incentives for industry may be needed, such as research grants, tax credits, awards for reaching successive preclinical stages of drug development, and prizes for notable innovations.

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