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Manufacturers tell FDA why they should be able to promote drugs and devices off label

BMJ 2016; 355 doi: https://doi.org/10.1136/bmj.i6098 (Published 14 November 2016) Cite this as: BMJ 2016;355:i6098

Rapid Response:

Re: Manufacturers tell FDA why they should be able to promote drugs and devices off label

The FDA requires two well-conducted clinical trials demonstrating statistically significant results in favor of a drug for efficacy approval. While this is a permissive standard, the FDA at least adheres to one important element of analysis not strictly enforced by journal editors or in other venues - they require statistical separation in the declared a priori defined primary outcome variables for approval. On the other hand, this request for the FDA to "allow industry to use 'postapproval clinical trials ... post hoc analyses, subpopulation analysis, observational data, real world evidence, and physician treatment guidelines' to support claims about off-label uses" is literally a listing of areas where efficacy has regularly been misreported using "outcome switching" among the many other methods of introducing bias. Given industry's track record over the last several decades, it is the height of hubris to even suggest such changes.

Competing interests: No competing interests

15 November 2016
John M. Nardo
Psychiatrist
Emory University
Jasper GA US