Posted On: 09/23/2015 10:18:25 PM
Post# of 72446
Like JAMA, the BMJ on a "First Do No Harm" warpath of sorts re expedited approval pathways... See the three articles below. The second is full of good data. Prob best overview of the various accelerated paths to approval.
Luckily the chief complaint doesn't apply to Brilacidin (HDP/Defensin-mimetics) and Kevetrin (p53) ---- that drugs getting assigned expedited designations typically don't represent "First in Class" compounds, ie, not up to snuff outcomes-wise (though tell that to patients... What's a few extra months of life???).
Gotta think Fast Track (for
and/or Breakthrough/Orphan (for K) in the nearer term.
Still buying.
1) "The FDA’s new clothes" (Editorial)
BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h4897 (Published 23 September 2015)
Cite this as: BMJ 2015;351:h4897
http://www.bmj.com/content/351/bmj.h4897
The FDA does not protect patients from harmful or ineffective drugs, but approves both
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2) "Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study"
BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h4633 (Published 23 September 2015)
Cite this as: BMJ 2015;351:h4633
http://www.bmj.com/content/351/bmj.h4633
Conclusions In the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs. Though expedited programs should be strictly limited to drugs providing noticeable clinical advances, this trend is being driven by drugs that are not first in class and thus potentially less innovative.
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"Why do cancer drugs get such an easy ride?"
BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h2068 (Published 23 April 2015)
Cite this as: BMJ 2015;350:h2068
http://www.pharmamyths.net/files/BMJ_Easy_Ride_ARTICLE.pdf
Luckily the chief complaint doesn't apply to Brilacidin (HDP/Defensin-mimetics) and Kevetrin (p53) ---- that drugs getting assigned expedited designations typically don't represent "First in Class" compounds, ie, not up to snuff outcomes-wise (though tell that to patients... What's a few extra months of life???).
Gotta think Fast Track (for
and/or Breakthrough/Orphan (for K) in the nearer term. Still buying.
1) "The FDA’s new clothes" (Editorial)
BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h4897 (Published 23 September 2015)
Cite this as: BMJ 2015;351:h4897
http://www.bmj.com/content/351/bmj.h4897
The FDA does not protect patients from harmful or ineffective drugs, but approves both
///
2) "Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study"
BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h4633 (Published 23 September 2015)
Cite this as: BMJ 2015;351:h4633
http://www.bmj.com/content/351/bmj.h4633
Conclusions In the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs. Though expedited programs should be strictly limited to drugs providing noticeable clinical advances, this trend is being driven by drugs that are not first in class and thus potentially less innovative.
///
"Why do cancer drugs get such an easy ride?"
BMJ 2015; 350 doi: http://dx.doi.org/10.1136/bmj.h2068 (Published 23 April 2015)
Cite this as: BMJ 2015;350:h2068
http://www.pharmamyths.net/files/BMJ_Easy_Ride_ARTICLE.pdf
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