Off Label Prescriptions- New Trends
With so many instructions and warnings on a bottle of prescription pills, one would think that the last person to disregard the intended use of a drug would be the doctor prescribing it. “Off-label” prescriptions are exactly that, and a number of legal cases are coming to trial because of the growing trend in pharmaceutical marketing of encouraging this practice.
Off-label prescriptions exist in a gray area of medicine. Birth control is regularly prescribed for minimizing menstrual cramps and clearing up acne. Rogaine’s use for baldness was prescribed off-label for years before the FDA approved it. So that while the practice is not in keeping with FDA regulations, some advocates claim that the practice is not necessarily illegal either.
James Beck, a defense attorney and co-author of the Drug and Device Law blog, claims that most off-label use is beneficial and it is only the few disasters that get noticed. In fact, in 2008 the FDA rules for the promotion of off-label drug use became lax, but the Obama administration has yet to review these new regulations.
However the cases that have come to trial have not been about doctors finding creative ways to treat patients; they are about corporate marketing systems designed to create new outlets for sales.
For example, in March, Johnson & Johnson was ordered to pay the state of West Virginia $3.95 million for misleading doctors about the risks and benefits of Risperdal, an antipsychotic. The pharmaceutical giant is facing an even larger case in Texas. (http://industry.bnet.com/pharma/10001223/jj-fined-5000-per-sales-rep-visit-for-risperdal-mismarketing/).