Off label use is a drug is prescribed for a purpose, at a dose, or through a route of administration that has not been approved by the FDA. After clinical testing the FDA approves drugs for specific conditions and in specified dosages. The FDA does not control the practice of medicine. Once the FDA approves a drug it is now available for the doctor to prescribe for whatever purpose and in whatever dosage the doctor deems appropriate. It is common practice for doctors to prescribe drugs for conditions and in dosages for which the FDA has not tested the drug. The patient has a right to know if any drug which has been prescribed for him is being prescribed off label. Ask the doctor and review the package insert to make sure the drug you are taking has been approved for the purpose and in the amount prescribed for you.
Cumberland School of Law, Cum Laude graduate Peter F. Burns practice areas include business litigation will contests, medical malpractice, legal malpractice, and other matters of complex civil litigation. Mr. Burns is licensed to practice before the United States Supreme Court and is a Certified Alabama Mediator; Board-Certified Civil Trial Advocate, National Board of Trial Advocacy, and a member of national and state Legal associations.