As we recently discussed, a number pharmaceutical companies have been fined for promoting off-label uses of their drugs. These practices are difficult to control and the monetary penalties seem to have had little effect on manufacturers, as the number of off-label breaches being reported continues to grow.
In the world of contemporary medicine, off-label prescribing plays a fundamental role in providing the best available standard of care for several health problems. In some areas of practice, including oncology, pediatrics and obstetrics, off-label prescribing provides some of the best known interventions for patients. Yet, off-label prescriptions can also threaten the safety of the patients if they are not supported by legitimate scientific evidence. Hence, promoting such uses of drugs is not encouraged by the regulatory authorities with a view to safeguard the health of patients (a key regulatory role). (more…)