Off Label: Should device makers be allowed to sell doctors on untested uses?


When the FDA allows a drug or device on the market, it is only for certain kinds uses that have been (to some degree) tested for safety.  The manufacturers are not allowed to send sales reps to push doctors to try devices out in untested ways.  Based on some recent lower court rulings touching on the freedom of speech, this prohibition on “off label promotion” has been under fire.  This week, the FDA held a hearing on whether to loosen these restrictions.

The Minnesota Star Tribune has a great writeup of the issue.