[e-drug] Patented new uses for old drugs (9)

["Kevin Outterson" <Kevin.Outterson@mail.wvu.edu>]

E-DRUG: Patented new uses for old drugs (9)
-------------------------------------------

In the US, physicians are permitted to prescribe off-label.   It is
possible for a physician to prescribe the generic for a patented
indication.  The companies try to prevent this by conducting the
clinical studies for the patented use in different dosages or forms. 
For example, BiDil (the so-called African-American heart drug) is a
fixed dose combination with dosages not currently available in generic
form.  A physician could prescribe the generics (saving the patient 5
times the cost), but no peer-reviewed literature exists to validate the
dosages available, leaving everyone to guessing or pill splitting. 
Generic companies are generally not allowed to market off-label uses
(the law is more complicated, but that is the general picture).
 
Occasionally, US managed care techniques might interfere too (contrary
to financial interests) to block a prescription without the 'correct'
underlying diagnosis.
 
Kevin Outterson
 
Associate Professor of Law
West Virginia University
304 293 8282
kevin.outterson@mail.wvu.edu