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

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 …