How to prevent the next Marathon Pharmaceuticals [version 1; referees: awaiting peer review]

In recent years, several drug companies have exploited U.S. regulatory policies to acquire exclusive rights to cheap therapies and substantially raise their prices, and Federal agencies and state governments are exploring various ways to prevent or punish such behavior in the future. Among these cases, however, Marathon Pharmaceuticals’ handling of Emflaza (deflazacort) is unique, because the drug was previously only available abroad, and was never previously sold in the U.S. before the company obtained FDA approval for it. Thus, laws and policies designed to address price hikes on already-marketed drugs are unlikely to prevent additional Marathon-like scenarios. In this article, we describe in more detail the unique features of Emflaza compared with these other recent cases of drug price increases, determine the likelihood that similar situations will arise in the future, and explore legislative and administrative options to specifically prevent such behavior. Frank S. David ( ) Corresponding author: [email protected] : Conceptualization, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing; : Author roles: David FS Dixit R Data Curation, Investigation, Writing – Review & Editing The authors work for Pharmagellan, a pharmaceutical consulting firm. Neither author has ever been employed as a Competing interests: consultant to any of the companies named in this article, nor does either author have any current or prior investments in any of the named companies. David FS and Dixit R. How to cite this article: How to prevent the next Marathon Pharmaceuticals [version 1; referees: awaiting peer 2018, :74 (doi: ) review] F1000Research 7 10.12688/f1000research.13678.1 © 2018 David FS and Dixit R. This is an open access article distributed under the terms of the , Copyright: Creative Commons Attribution Licence which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The author(s) declared that no grants were involved in supporting this work. Grant information: 17 Jan 2018, :74 (doi: ) First published: 7 10.12688/f1000research.13678.1 Referee Status: AWAITING PEER REVIEW 17 Jan 2018, :74 (doi: ) First published: 7 10.12688/f1000research.13678.1 17 Jan 2018, :74 (doi: ) Latest published: 7 10.12688/f1000research.13678.1 v1 Page 1 of 5 F1000Research 2018, 7:74 Last updated: 17 JAN 2018