OFF LABEL PRESCRIPTIONS & INFORMED CONSENT

The FDA approves drugs in specified dosages for specific conditions. If the manufacturer markets a drug for a condition or at a dosage not approved by the FDA the manufacturer faces civil and criminal penalties. The penalties can be substantial because of the risk to public health. The Department of Justice has announced that it will fine Pfizer $2.3 billion for “off label” marketing of the drugs Bextra, Zyvox, Geodon and Lyrica. This is the biggest penalty the government has imposed on any company in American history.

Doctors have more latitude than drug manufacturers. The FDA cannot practice medicine or tell doctors how they should. Consequently, once the FDA approves a drug for one condition doctors are free to prescribe the drug for untested age groups, in untested dosages and to treat conditions other than those for which the drug has been proven effective. For example, a drug the FDA approved to treatment of depression in adults can be prescribed to treat headaches in children.

If a doctor is going to make an off label prescription the patient has a right to know. Once informed that the drug has not been proven effective for the condition or safe in dosage or for the age group the patient can decide if she will accept the risk.