regulators draw an important distinction between what is permitted for doctors and what is permitted for drug companies. While clinicians can prescribe off label, using their own judgment, it is generally forbidden for a pharmaceutical company to promote a product for off-label uses. The rationale is that in determining what is safe and appropriate for a patient, a highly trained doctor should be given leeway to depart from FDA guidance, but a drugmaker should be given no leeway at all, in view of its obvious bias. (Recent legal challenges have carved out exceptions and eroded enforcement, but
...more