The ability of physicians to prescribe approved
medicines for purposes not sanctioned by the Food and Drug
Administration is one of the most important elements of medical
care in the United States. These “off-label” uses are perfectly
legal, and doctors rely on them extensively. But the FDA views
off-label prescribing as an attempt to circumvent its control over
the nation’s pharmaceutical supply and has put a number of
restrictions in place that hurt both doctors and patients.

The most prominent rule entirely forbids drug manufacturers from
promoting off-label uses. But that might change soon, however,
reports Gregory Conko and Henry Miller, because two different
federal courts are now considering lawsuits challenging the
constitutionality of the off-label promotion ban. And given a
string of recent Supreme Court cases affirming commercial free
speech rights, one of those cases may at least partially invalidate
the FDA’s restrictions.