FDA's Expedited Programs Assessed for Time of Drug Development

Shorter development time for breakthrough, non-fast-track versus fast-track, non-breakthrough drugs
Shorter development time for breakthrough, non-fast-track versus fast-track, non-breakthrough drugs

HealthDay News — Drugs with breakthrough status have the shortest median development time, according to a research letter published in the December 5 issue of the Journal of the American Medical Association.

Thomas J. Hwang, from Brigham and Women's Hospital in Boston, and colleagues examined development times for drugs enrolled in fast-track or breakthrough programs. Clinical development times were calculated as the time from the Investigational New Drug application to first Food and Drug Administration approval. 

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Sixty percent of the 174 new drug approvals were in 1 or more expedited programs. The researchers found that the expedited programs included priority review (90 drugs), accelerated approval (26 drugs), fast-track (63 drugs), and breakthrough (29 drugs). The median development time was 7.1 years for drugs in at least 1 expedited program, compared with 8.0 years for non-expedited drugs (P=0.04). Development times were not significantly different for drugs with priority review or accelerated approval versus no expedited program, for non-breakthrough, non-fast-track drugs (8.2 versus 8.0 years; P=0.35). Fast-track versus non-fast-track drugs (7.0 versus 8.0 years; P=0.03) and breakthrough versus non-breakthrough drugs (4.8 versus 8.0 years; P<0.001) had shorter development times, regardless of other programs. Shorter development times were seen for breakthrough, non-fast-track drugs versus fast-track, non-breakthrough drugs (4.7 versus 7.1 years; P=0.001).

"The shortest median development time of 4.8 years (32% shorter than fast-track drugs) was observed for drugs with breakthrough status," the authors write.

One author disclosed financial ties to Blackstone and Bain Capital, which have invested in health care companies.

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