Off-label [that is, non-FDA approved] drug use is controversial. Some drug sellers, doctors, and patients think that cautious unapproved drug use advances medical science while helping to mitigate and cure disease, while some consumer advocates thinks it kills and injures patients. Law professors Fazel Kahn and Justin Holloway have written "Verify, then Trust: How to Legalize Off-Label Drug Marketing," which they claim proposes an optimal solution to the problem. Here is the abstract:
To
maximize profits, major pharmaceutical companies (“pharma”) primarily
rely on two disparate business practices innovation and marketing.
Obviously, discovering additional uses for pre-existing drugs can result
in an expanded market and increased profits for these products.
However, it is illegal for pharma to actively market these “offlabel”
uses without securing FDA approval for these additional indications.
Pharma, however, can conduct research outside of the FDA regulatory
process to discover additional uses for a specific drug. In turn, these
studies on alternative uses might persuade doctors to prescribe the drug
in an off-label manner, but only if doctors become aware that such
off-label uses are medically indicated. How this off-label usage
information reaches doctors is a contentious legal point.
This
article will discuss the current state of off-label medicine, relevant
legislation in the area, and a proposal designed to capture the benefits
of off-label medicine while limiting its dangers when practiced
perniciously. Part II will discuss the regulations in place governing
offlabel promotion and will detail the practice of ghostwriting and its
associated concerns. Part III will analyze the costs and benefits of
offlabel marketing and practice of medicine, and will utilize a case
study to demonstrate the predicament of drug manufacturers. Part IV will
set forth a proposal to use the newly created Patient-Centered Outcomes
Research Institute to generate unbiased research on off-label uses,
which, in turn, would create a safe harbor for drug companies to widely
disseminate studies generated through this process to the medical
community. Finally, Part V will present concluding thoughts on the
overarching policy considerations driving the need for legislative
reform.
