Food and Drug Administration Modernization Act

The Food and Drug Administration Modernization Act of 1997 (FDAMA) ended the federal prohibition on marketing and promoting off-label uses of prescription drugs. This new law allowed limited marketing and promotion of off-label uses to certain audiences, including physicians, on the condition that the drug manufacturer had an application pending for FDA approval of the off-label use.

Drug manufacturers complained that did not go far enough in freeing restrictions on commercial speech with respect to their products.