Majority of Physicians Do Not Understand What Level of Evidence Supports FDA's "Breakthrough" Therapy Designation

In an article published by JAMA Oncology (JAMA Oncol; October 29, 2015), the authors noted that the use of superlatives to describe cancer drugs in news articles as “breakthrough,” “revolutionary,” “miracle” or in other grandiose terms was common even when drugs were not yet approved, had no clinical data or not yet shown overall survival benefits (read "Journalists & Physicians Use Superlatives, Some Supplied by FDA - e.g., "Breakthrough" - to Describe Unapproved Cancer Drugs").

Where do these terms come from?

It turns out that some of them come from the FDA, which uses a bevy of new drug approval designations that marketers and, in turn, journalists, can use to their advantage. In 2015, for example, 60% of of the 45 drugs approved by the FDA were designated in one or more the following categories: "Fast Track," "Breakthrough," "Priority Review," or "Accelerated Approval."

Perhaps the most advantageous designation as far as marketers are concerned is "Breakthrough". Ten (22%) of drugs approved in 2015 received the "Breakthrough" designation.

What level of evidence does the FDA require in order to label a drug a "Breakthrough" therapy? Take the following short survey (check a box and hit "Next" to see if your were right; then hit "Submit"). Click on "Read more >>" to see how physicians answered the question.


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