Week 5 Discussion Question
Please review all Week 5 Supporting materials regarding Off label Promotion and the various
FDA's guidance posted under the Week 5 Supporting Materials folder.
While off-label promotion by biomedical product manufacturers is illegal, the off-label use of
FDA approved drugs and devices is permitted when prescribed by a healthcare practitioner,
and falls under the individual professional responsibility to decide what treatment is best for
their patient. (Remember, FDA does not regulate the practice of medicine!). Off-label uses
are especially common in oncology and pediatric practice, where the treatments do not have
adequate clinical data to support all viable indications, but is approved for use in adults with
similar diagnoses. FDA has published its views on the dissemination of information
regarding unapproved uses of medical products.
In addition, in December 2012 a supreme court case was decided that adds controversy to this
issue (see summary at the link below)
United States v. Caronia: A Victory for Free Speech vs. Off Label Promotion – Policy &
Medicine.pdf
After reviewing the
Week 5 Supporting Materials
discuss in your post all the following
questions and include references:
After reviewing all of the Week 5 Required Reading, discuss whether or not the
Caronia ruling can impact patient safety and risk, while at the same time
benefiting the drug/device manufacturers. How can off label utilization of
biomedical products approved by FDA benefit, as well as potential harmful in
patient responsiveness to these products?
Refer to the RGA6002 syllabus for metrics regarding Discussion Board Participation
expectations and grading - As a reminder
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