Study Examines FDA’s Expedited Programs and Development Time of New Drugs to Treat Serious Diseases
9 Dec 2017
Bottom Line: Drugs reviewed by the FDA in programs intended to speed drug development were approved nearly a year quicker than drugs reviewed by the FDA through normal processes.
Why The Research Is Interesting: The U.S. Food and Drug Administration (FDA) has four programs to speed the development and review of drugs treating serious diseases. Clinical development times for drugs in these programs, particularly the newly created breakthrough program (enacted in 2012), have not been comprehensively assessed.
What (Study Measures) and When: Comparison of clinical development times for drugs and biologics approved by the FDA between January 2012 and December 2016 in expedited vs non-expedited programs.
How (Study Design): This is an observational study. Because researchers are not intervening for purposes of the study they cannot control natural differences that could explain the study findings.
Authors: Aaron S. Kesselheim, M.D., J.D., M.P.H., of Brigham and Women’s Hospital, Boston, and coauthors.
— Of 174 new drug approvals, 60 percent were in one or more expedited programs.
— The median development time for drugs in at least one expedited program was 7.1 years compared with 8 years for nonexpedited drugs.
Study Limitations: Only approved drugs were analyzed.
These previous articles from JAMA are also available:
Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration
Balancing the Need for Access With the Imperative for Empirical Evidence of Benefit and Risk
New “21st Century Cures” Legislation – Speed and Ease vs Science
Physicians’ Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation
For more details and to read the full study, please visit the For The Media website.