Abstract

The US Food and Drug Administration developed the Breakthrough Therapy designation to expedite the development and review of drugs that show a clear advantage over available therapy for serious conditions. Prior research has shown that physicians tend to misunderstand that a drug may receive a Breakthrough Therapy designation based on preliminary clinical evidence (eg, effect on a surrogate endpoint or intermediate clinical endpoint that is likely to predict clinical benefit). The objective of this article is to examine whether physicians’ familiarity with and interpretation of the Breakthrough Therapy designation have changed since a survey on the topic was published in 2016. We replicated three of the questions in that study and explored beliefs that a Breakthrough Therapy designation automatically qualifies a drug for accelerated approval. We also draw comparisons by specialization (oncologists vs. primary care physicians). In general, physicians remain more likely than not to misunderstand the Breakthrough Therapy designation.

Details

Title
Physician Perceptions of the FDA’s Breakthrough Therapy Designation: An Update
Author
Paquin, Ryan S 1 ; Boudewyns, Vanessa 1 ; Amie C O’Donoghue 2 ; Aikin, Kathryn J 2 

 RTI International, Research Triangle Park, NC, USA 
 Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, US Food and Drug Administration, Silver Spring, MD, USA 
Pages
e85-e88
Publication year
2022
Publication date
Jan 2022
Publisher
Oxford University Press
ISSN
10837159
e-ISSN
1549490X
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3191367495
Copyright
© The Author(s) 2022. Published by Oxford University Press. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.