If you are new to the concept of “off-label” prescriptions, you are not alone. When many people first hear the term, they equate it with a generic prescription. However, the two concepts could not be more different.
What is an “Off-Label” Prescription?
The term “off-label” refers to a doctor’s prescription that does not align with the FDA-approved use of a medication. Before manufacturers put new drugs on the market, they have to submit to review – and in many cases independent testing – in order to get FDA approval. But, even when a medication has been “approved,” that approval is only for a specific medical use. In other words, while a medication may be FDA-approved for certain uses, it will not be approved for others.
However, this does not stop doctors from prescribing unapproved uses of approved medications. The most common forms of off-label prescriptions include:
- Prescribing an unapproved dosage of an FDA-approved medication,
- Prescribing an approved medication to a patient who would not normally be a candidate for use, and
- Prescribing a drug to treat a condition not covered by the drug’s FDA approval.
Doctors may provide off-label prescriptions for a variety of different reasons. For example, off-label prescriptions are commonly used where:
- A new drug with significant benefits has been invented and doctors do not want to wait for the FDA approval before helping their patients,
- A new use has been discovered but the drug manufacturer is unwilling to bear the expense of seeking another FDA approval, or
- Medications have not been approved for use with certain patients (such as pregnant women and young children), even though those patients could benefit from a prescription.
Is Providing Off-Label Prescriptions a Form of Medical Malpractice?
Off-label prescriptions can have legitimate uses, and providing an off-label prescription is not in and of itself improper. However, doctors need to be careful when prescribing medications for unapproved purposes. If they fail to meet the standard of care – and their patients suffer as a result – they can be held liable for medical malpractice.
Are Drug Manufacturers Liable for Off-Label Prescriptions?
Similarly, drug manufacturers are not necessarily liable for illnesses and other complications caused by off-label prescriptions. For example, consider a situation where a manufacturer gets an FDA approval and packages its drugs properly. If a doctor then provides an off-label prescription, this is generally going to be considered beyond the manufacturer’s control.
However, the key here is proper packaging. If a manufacturer markets its drugs for off-label prescriptions, or if it fails to provide warnings about known risks of off-label uses, these are both situations where victims of dangerous drugs may be able to sue the manufacturer as well.