Gregory Conko and Henry Miller on the FDA vs. Doctors and Patients


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.