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Research Letter |

Physicians’ Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation

Aaron S. Kesselheim, MD, JD, MPH1; Steven Woloshin, MD, MS2,3; Wesley Eddings, PhD1; Jessica M. Franklin, PhD1; Kathryn M. Ross, MBE4; Lisa M. Schwartz, MD, MS2,3
[+] Author Affiliations
1Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, Massachusetts
2Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, New Hampshire
3Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
4American Board of Internal Medicine, Philadelphia, Pennsylvania
JAMA. 2016;315(14):1516-1518. doi:10.1001/jama.2015.16984.
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This survey study examines how well physicians understand the US Food and Drug Administration’s (FDA’s) statutory definition of a “breakthrough” therapy, and whether the term breakthrough affects their perceptions of a drug’s efficacy.

Before US patients can use new prescription drugs, the US Food and Drug Administration (FDA) reviews the clinical trial results to confirm that benefits outweigh harms for the indication. Approval may involve superiority to placebo, not to an active comparator or standard of care (although approval can be based on uncontrolled or historically controlled studies). Numerous pathways expedite drug development and approval for serious or life-threatening conditions. For example, since 2012, the FDA can designate a drug as a “breakthrough therapy” if preliminary clinical evidence—such as an improvement in a pharmacodynamic biomarker—suggests an advantage over existing options.1 Through April 2015, the FDA designated 76 “breakthrough” drugs,2 and the term is routinely used in press releases3 and prescribing resources.4

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The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
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