Intended for healthcare professionals


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

BMJ 2016; 355 doi: (Published 14 November 2016) Cite this as: BMJ 2016;355:i6098
  1. Jeanne Lenzer
  1. Washington DC

Manufacturers have told the US Food and Drug Administration (FDA) that restricting their ability to engage in “truthful and non-misleading speech” about off-label uses of drugs and devices infringes their rights to free speech.

The comments were made during hearings held in Washington, DC, on 9 and 10 of November on whether to allow manufacturers to promote drugs and medical devices for uses not approved by the FDA. Public comment on the proposal to loosen off-label promotion is open until 9 January 2017.

One in every five prescriptions in the US is estimated to be for off-label use. For example, the use of certain antibiotics in children, which have been tested and approved in adults, is one commonly accepted off-label use. But manufacturers are generally prohibited from promoting off-label use, with the exception of “safe harbor” activities, such as distributing reprints of peer reviewed journal articles …

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