Consumer Law

Off-Label Use of Prescription Drugs

If you're prescribed a medication for a reason other than what the drug was approved for, this is known as off-label use. Off-label use - also known as a non-approved or unapproved use - is a very common practice. In fact, some drugs are prescribed more often for their off-label use than their approved use.

FDA Approval

The US Food and Drug Administration (FDA) is responsible for approving a drug so it can be prescribed by your doctor. Under the Food, Drug and Cosmetic Act, the drug company must specify the intended use of the drug in its application to the FDA. Before the FDA approves a drug, it requires that the drug company conduct clinical trials to make sure the drug is safe and effective in treating the condition stated in the application.

Once it's shown that the drug is safe and effective, the FDA and the drug company have to agree on the language that must be included in the drug labeling. Drug labeling includes the label, the wrapping and the package insert.

The drug labeling must include:

  • Name of the drug
  • Critical warnings
  • Dosage information
  • Instructions on how to take the medication, e.g., with water
  • Foods and drugs you should avoid while taking the medication
  • Approved use of the medicine
  • Contraindications - i.e., conditions under which you should not take the drug, e.g., if you are pregnant, have kidney problems, etc.
  • Side effects and symptoms of adverse reactions
  • Storage instructions, e.g., whether the drug should be refrigerated

Finally, because the label is not intended to be all-inclusive, it should also contain general information such as a statement advising you to discuss any questions you may have with a health professional.

Illegal Marketing of Off-Label Use

It's illegal for a drug company to market or promote a drug to a doctor or consumer for any use not stated in their application - no matter how effective the drug may be for a different medical condition.

The US Department of Justice, with assistance from the FDA, aggressively pursues criminal and civil cases against drug companies for promoting off-label uses of prescription drugs.

In 2004, Warner-Lambert pled guilty and paid more than $430 million to resolve criminal and civil charges brought against them for illegally and fraudulently promoting the unapproved use of one of its drugs.

Standard of Care

The FDA does not regulate the practice of medicine. After the FDA has approved a drug, a doctor is free to decide how to use it. It is legal for a doctor to prescribe an off-label use of an approved drug to treat a patient's condition. However, in doing so, a doctor is necessarily deviating from the standard of care.

Standard of care refers to the treatment that experts agree is appropriate for a particular medical condition. Doctors are legally obligated to provide their patients with the appropriate standard of care. If the patient experiences a bad reaction to the drug, the doctor may be liable for deviating from the standard of care for the patient's medical condition.

What about Insurance Coverage?

Many insurance companies refuse to pay for an expensive drug that's prescribed for an off-label use on the basis that it's an experimental treatment. You should check your insurance plan's coverage provisions prior to purchasing a drug prescribed for an off-label use.

If your insurance company denies reimbursement, you can appeal and ask your doctor to provide authoritative information that demonstrates the effective use of the drug for your condition, such as medical journal articles.

Ask Questions

If your doctor prescribes an off-label use of a drug to treat your medical condition, don't be afraid to ask questions. The drug label won't provide you with any information related to off-label use. The label will only contain information about the FDA-approved use of the drug based on the research conducted during the clinical trials.

Ask your doctor if prescribing the off-label use of the drug will be more effective than the use of an approved drug, and whether there are any risks associated with the off-label use that you should know about. Be aware that lack of clinical information about off-label use of drugs may put you at greater risk for an harmful reactions.

Questions for Your Attorney

  • Does off-label drug use include prescribing a medication for groups of people other than those for which the drug was approved, such as prescribing a medication for a child? Could a doctor or manufacturer face liability in those cases?
  • Are drugs approved for certain diagnosed conditions, or for symptoms? For example, is it off-label use if an allergy patient occasionally uses asthma prescriptions, when no diagnosis of asthma has been made?
  • Does off-label use of a drug ever become so widespread in a medical specialty that it becomes part of the standard of care, even if that departs from the drug's original approved use? Does this factor into lawsuits if people start experiencing harmful side effects from using a drug in an off-label manner?
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