Assessing the FDA’s Breakthrough Drug Program After Six Years image

ASH Clinical News, April 25, 2018
ASH Clinical News, quoting Jonathan J. Darrow (Student Fellow Alumnus)

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From the article:

In the first four years of the U.S. Food and Drug Administration’s (FDA) breakthrough-therapy designation program, the agency approved 31 “breakthrough” drugs, but many were approved with limited evidence of added benefit, according to a health-policy report published in The New England Journal of Medicine.

The breakthrough-therapy designation program was created by Congress in 2012 to expedite testing and approval of medications that were intended to treat serious or life-threatening conditions, the authors, Jonathan J. Darrow, JD, MBA; Jerry Avorn, MD; and Aaron S. Kesselheim, MD, JD, MPH, explained.

“When drugs are designated as breakthroughs and expedited through the FDA approval process with the use of substantial resources, many patients and physicians will reasonably expect such drugs to offer major advances,” the authors wrote, noting that “new drugs can meet technical requirements for the designation, and then be approved, despite having only modest efficacy.”

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