Changes in the Use of Hydroxyprogesterone Caproate Injection After Confirmatory Trial Failure

Authors

Rachel Sachs, Washington University in St. Louis School of LawFollow
Kyle A, Gavulic, Yale School of MedicineFollow
Julie M. Donohue, University of Pittsburgh School of Public HealthFollow
Stacie B. Dusetzina, Vanderbilt University Medical Center Department of Health PolicyFollow

Document Type

Article

Publication Date

2022

Publication Title

Journal of the American Medical Association Internal Medicine

Abstract

The US Food and Drug Administration (FDA) accelerated approval pathway allows new drugs with uncertain clinical benefits to be approved on the basis of clinical trials involving surrogate end points. For state Medicaid programs, which must cover nearly all drugs, including those receiving accelerated approval, stakeholders are concerned about spending on accelerated approval products that remain on the market despite failing to complete FDA-required follow-on clinical trials or where those trials fail to confirm clinical benefits.

Keywords

Hydroxyprogesterone Caproate Injection, Confirmatory Trial Failure

Publication Citation

Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue & Stacie B. Dusetzina, Changes in the Use of Hydroxyprogesterone Caproate Injection After Confirmatory Trial Failure, 182 J. Am. Med. Ass’n Internal Medicine 226 (2022)

Comments

Sachs RE, Gavulic KA, Donohue JM, Dusetzina SB. Changes in the Use of Hydroxyprogesterone Caproate Injection After Confirmatory Trial Failure. JAMA Intern Med. 2022;182(2):226–227. doi:10.1001/jamainternmed.2021.7001

Repository Citation

Sachs, Rachel; Gavulic, Kyle A,; Donohue, Julie M.; and Dusetzina, Stacie B., "Changes in the Use of Hydroxyprogesterone Caproate Injection After Confirmatory Trial Failure" (2022). Scholarship@WashULaw. 297.
https://openscholarship.wustl.edu/law_scholarship/297