Myth 4: The FDA regulates the practice of medicine.
FACT: The FDA regulates the approval of a drug, but not how it is prescribed. Doctors are permitted to prescribe a drug for any reason they think is medically appropriate.
The FDA creates the “drug label” in conjunction with the drug company to ensure that promotional claims are not false or misleading. The drug label of FDA-approved drugs provides information about the drug, including the approved doses and how the drug should be given to treat the medical condition for which it was approved.
However, physicians often use drugs in a way that is different from that described in the FDA-approved drug label, an “off-label” use. This can mean that the drug is:
• Used for a different disease or medical condition.
• Given in a different way (such as by a different route).
• Given in a different dose.
Off-label is also called “nonapproved” or “unapproved” use of a drug. Because drug makers have not put their drugs through the studies required by the FDA to officially approve the drug for new uses, new uses for these drugs should be taken with caution as the FDA has not reviewed the clinical evidence to support the new use. Any off-label drug usage should include a detailed conversation between physician and patient.4
Dr. John J. Whyte is the director of Professional Affairs and Stakeholder Engagement (PASE) in the FDA’s Center for Drug Evaluation and Research (CDER).