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Opening the FDA Black Box

Opening the FDA Black Box Opinion Editorials represent the opinions of the authors and JAMA EDITORIAL and not those of the American Medical Association. Steven N. Goodman, MD, MHS, PhD; Rita F. Redberg, MD, MSc The US Food and Drug Administration (FDA) is sometimes de- not; or, if so, whether the sponsor did not follow the agreed-on scribed as the most powerful regulatory agency in the world, design or whether the FDA changed its decision after the trial. its decisions affecting billions of both lives and dollars. The For trials that did not show sufficient efficacy, it was not clear agency has this distinction whether this was attributable to design weaknesses, such as not just because of its legisla- single intervention groups or nonmasked assessments, or tive mandate or governmen- whether it was simply attributable to small effect sizes in oth- Related articles pages 368, tal role but in part because of erwise exemplary studies. 378, and 385 its reputation. This reputa- Sacks et al make the observation that only 1 new tion has been shaped by how it makes its decisions, by its “con- molecular entity approved during the 12 years of their study ceptual power” in the language and methodologic standards was http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Opening the FDA Black Box

Goodman, Steven N.; Redberg, Rita F.
JAMA , Volume 311 (4) – Jan 22, 2014
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References (19)

Publisher
American Medical Association
Copyright
Copyright 2014 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2013.283946
pmid
24449313
Publisher site
See Article on Publisher Site

Abstract

Opinion Editorials represent the opinions of the authors and JAMA EDITORIAL and not those of the American Medical Association. Steven N. Goodman, MD, MHS, PhD; Rita F. Redberg, MD, MSc The US Food and Drug Administration (FDA) is sometimes de- not; or, if so, whether the sponsor did not follow the agreed-on scribed as the most powerful regulatory agency in the world, design or whether the FDA changed its decision after the trial. its decisions affecting billions of both lives and dollars. The For trials that did not show sufficient efficacy, it was not clear agency has this distinction whether this was attributable to design weaknesses, such as not just because of its legisla- single intervention groups or nonmasked assessments, or tive mandate or governmen- whether it was simply attributable to small effect sizes in oth- Related articles pages 368, tal role but in part because of erwise exemplary studies. 378, and 385 its reputation. This reputa- Sacks et al make the observation that only 1 new tion has been shaped by how it makes its decisions, by its “con- molecular entity approved during the 12 years of their study ceptual power” in the language and methodologic standards was

Journal

JAMA – American Medical Association

Published: Jan 22, 2014

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