ASJ’s Position on Publishing Papers That Discuss Off-Label Product Usage

ASJ’s Position on Publishing Papers That Discuss Off-Label Product Usage Editor’s Note Aesthetic Surgery Journal 2018, Vol 38(2) NP44 ASJ’s Position on Publishing Papers That © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: Discuss Off-Label Product Usage journals.permissions@oup.com DOI: 10.1093/asj/sjx205 www.aestheticsurgeryjournal.com Foad Nahai, MD, FACS Editorial Decision date: October 4, 2017; online publish-ahead-of-print December 16, 2017. As the Editor-in-Chief of Aesthetic Surgery Journal (ASJ), Funding I would like to thank Dr Solomon for his Letter to the Editor The author received no financial support for the research, entitled “Comments on ‘Nonsurgical Medical Penile Girth authorship, and publication of this article. Augmentation: Experience-Based Recommendations.’” One of Dr Solomon’s remarks calls for a response. REFERENCES Dr Solomon’s comment that “the US Food and Drug 1. Solomon MP. Comments on “Nonsurgical Medical Penile Administration has not approved any filler for penile injec- Girth Augmentation: Experience-Based Recommendations”. tion therapy” whilst accurate should not be taken as an Aesthet Surg J. 2018;38(2):NP39–NP41. argument against the legality or efficacy of hyaluronic 2. Understanding Unapproved Use of Approved Drugs “Off acid for that purpose. The Food and Drug Administration Label”. https://www.fda.gov/forpatients/other/offla- (FDA) does not regulate the practice of medicine, and once bel/default.htm. Buckman Company vs. Plaintiffs’ Legal a product has an approved use on its label, a physician Committee (2001 U.S. Supreme Court) 531 US 341, 350. may use that product off-label “within a legitimate health Accessed October 3, 2017. care practitioner-patient relationship.” 3. The International Study on Aesthetic/Cosmetic Procedures ASJ, as the official English-language journal for the Performed in 2016. http://www.isaps.org/Media/Default/ American Society for Aesthetic Plastic Surgery and 22 Current%20News/GlobalStatistics2016.pdf. Accessed national societies, proudly offers well-researched medical October 3, 2017. procedures, techniques, and opinions from a variety of our international colleagues. ASJ regularly publishes papers on drugs, biologics, and devices that are not FDA-approved, because the FDA regulates only 14% of the global aesthetic surgery market. Since 86% of all aesthetic surgeries in 2016 took place outside of the FDA’s jurisdiction, ASJ will always look beyond its American borders so as to provide Dr Nahai is a Professor of Plastic Surgery, Department of Surgery, aesthetic medicine research with worldwide relevance. Emory University School of Medicine, Atlanta GA; and is Editor-in- Chief of Aesthetic Surgery Journal. Disclosures Corresponding Author: The author declared no potential conflicts of interest with Dr Foad Nahai, 3200 Downwood Circle, Suite 640, Atlanta, GA respect to the research, authorship, and publication of this 30327, USA. article. E-mail: journal@surgery.org Downloaded from https://academic.oup.com/asj/article-abstract/38/2/NP44/4754060 by Ed 'DeepDyve' Gillespie user on 16 March 2018 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Aesthetic Surgery Journal Oxford University Press

ASJ’s Position on Publishing Papers That Discuss Off-Label Product Usage

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Publisher
Oxford University Press
Copyright
© 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com
ISSN
1090-820X
eISSN
1527-330X
D.O.I.
10.1093/asj/sjx205
Publisher site
See Article on Publisher Site

Abstract

Editor’s Note Aesthetic Surgery Journal 2018, Vol 38(2) NP44 ASJ’s Position on Publishing Papers That © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: Discuss Off-Label Product Usage journals.permissions@oup.com DOI: 10.1093/asj/sjx205 www.aestheticsurgeryjournal.com Foad Nahai, MD, FACS Editorial Decision date: October 4, 2017; online publish-ahead-of-print December 16, 2017. As the Editor-in-Chief of Aesthetic Surgery Journal (ASJ), Funding I would like to thank Dr Solomon for his Letter to the Editor The author received no financial support for the research, entitled “Comments on ‘Nonsurgical Medical Penile Girth authorship, and publication of this article. Augmentation: Experience-Based Recommendations.’” One of Dr Solomon’s remarks calls for a response. REFERENCES Dr Solomon’s comment that “the US Food and Drug 1. Solomon MP. Comments on “Nonsurgical Medical Penile Administration has not approved any filler for penile injec- Girth Augmentation: Experience-Based Recommendations”. tion therapy” whilst accurate should not be taken as an Aesthet Surg J. 2018;38(2):NP39–NP41. argument against the legality or efficacy of hyaluronic 2. Understanding Unapproved Use of Approved Drugs “Off acid for that purpose. The Food and Drug Administration Label”. https://www.fda.gov/forpatients/other/offla- (FDA) does not regulate the practice of medicine, and once bel/default.htm. Buckman Company vs. Plaintiffs’ Legal a product has an approved use on its label, a physician Committee (2001 U.S. Supreme Court) 531 US 341, 350. may use that product off-label “within a legitimate health Accessed October 3, 2017. care practitioner-patient relationship.” 3. The International Study on Aesthetic/Cosmetic Procedures ASJ, as the official English-language journal for the Performed in 2016. http://www.isaps.org/Media/Default/ American Society for Aesthetic Plastic Surgery and 22 Current%20News/GlobalStatistics2016.pdf. Accessed national societies, proudly offers well-researched medical October 3, 2017. procedures, techniques, and opinions from a variety of our international colleagues. ASJ regularly publishes papers on drugs, biologics, and devices that are not FDA-approved, because the FDA regulates only 14% of the global aesthetic surgery market. Since 86% of all aesthetic surgeries in 2016 took place outside of the FDA’s jurisdiction, ASJ will always look beyond its American borders so as to provide Dr Nahai is a Professor of Plastic Surgery, Department of Surgery, aesthetic medicine research with worldwide relevance. Emory University School of Medicine, Atlanta GA; and is Editor-in- Chief of Aesthetic Surgery Journal. Disclosures Corresponding Author: The author declared no potential conflicts of interest with Dr Foad Nahai, 3200 Downwood Circle, Suite 640, Atlanta, GA respect to the research, authorship, and publication of this 30327, USA. article. E-mail: journal@surgery.org Downloaded from https://academic.oup.com/asj/article-abstract/38/2/NP44/4754060 by Ed 'DeepDyve' Gillespie user on 16 March 2018

Journal

Aesthetic Surgery JournalOxford University Press

Published: Feb 1, 2018

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