Ideas and Opinions
1 October 2019

Fool Me Twice? The Reemergence of Rofecoxib and the Orphan Drug Act

Publication: Annals of Internal Medicine
Volume 171, Number 8
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References

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FDA grants orphan drug designation for TRM-201 (rofecoxib) for the treatment of hemophilic arthropathy. Business Wire. 21 November 2017. Accessed at www.businesswire.com/news/home/20171121005216/en/FDA-Grants-Orphan-Drug-Designation-TRM-201-rofecoxib on 15 April 2019.
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U.S. Food and Drug Administration. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. 31st ed. Washington, DC: U.S. Department of Health and Human Services; 2011.
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Kesselheim ASMyers JASolomon DHet al. The prevalence and cost of unapproved uses of top-selling orphan drugs. PLoS One. 2012;7:e31894. [PMID: 22363762]  doi: 10.1371/journal.pone.0031894
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Information & Authors

Information

Published In

cover image Annals of Internal Medicine
Annals of Internal Medicine
Volume 171Number 815 October 2019
Pages: 578 - 579

History

Published online: 1 October 2019
Published in issue: 15 October 2019

Keywords

Authors

Affiliations

Theodore T. Lee, JD
Yale Law School, Yale University, New Haven, Connecticut (T.T.L.)
Daniel H. Solomon, MD, MPH
Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (D.H.S.)
Aaron S. Kesselheim, MD, JD, MPH
Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts (A.S.K.)
Acknowledgment: The authors thank Dr. Ameet Sarpatwari, JD, PhD, for his comments on an earlier draft.
Financial Support: Dr. Kesselheim's work is funded by the Open Society Foundations, as well as by Arnold Ventures, the Engelberg Foundation, and the Harvard-MIT Center for Regulatory Science.
Corresponding Author: Aaron S. Kesselheim, MD, JD, MPH, Division of Pharmacoepidemiology & Pharmacoeconomics, 1620 Tremont Street, Suite 3030, Boston, MA 02120; e-mail, [email protected].
Current Author Addresses: Mr. Lee: 1114 Avenue of the Americas, Floor 43, New York, NY 10036.
Dr. Solomon: Division of Rheumatology, Brigham and Women's Hospital, 60 Fenwood Road, Boston, MA 02115.
Dr. Kesselheim: Division of Pharmacoepidemiology & Pharmacoeconomics, 1620 Tremont Street, Suite 3030, Boston, MA 02120.
Author Contributions: Conception and design: T.T. Lee, D.H. Solomon, A.S. Kesselheim.
Drafting of the article: T.T. Lee.
Critical revision of the article for important intellectual content: T.T. Lee, D.H. Solomon, A.S. Kesselheim.
Final approval of the article: T.T. Lee, D.H. Solomon, A.S. Kesselheim.
Obtaining of funding: A.S. Kesselheim.
This article was published at Annals.org on 1 October 2019.

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Theodore T. Lee, Daniel H. Solomon, Aaron S. Kesselheim. Fool Me Twice? The Reemergence of Rofecoxib and the Orphan Drug Act. Ann Intern Med.2019;171:578-579. [Epub 1 October 2019]. doi:10.7326/M19-1218

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