Abstract:
For many years, the off-label use of drugs has been a debated issue for healthcare administrators,
regulators, pharmaceutical manufacturers, doctors, pharmacists, insurance companies, and patients.
The mechanism for monitoring and regulating the off-label use of drugs must have sound scientific
evidence and principles that provide for discouraging their use in the absence of convincing and
evidence-based clinical justification and the availability of alternatives. Regulatory authorities (FDA and
others) are very strict about manufacturing standards and documentation of the safety and efficacy of
drugs, but they do not regulate the way they are prescribed. Thus, doctors can prescribe drugs off-label
if their medical knowledge and the patient's condition allow it. The decision to use the drug off -label is
not illegal if the doctor does not abuse his official position and does not violate the rules for its
prescription.
