What Is Off-Label Drug Use?
Off-label drug use (OLDU) is the use of an FDA-approved pharmaceutical drug for an unapproved use. It is a common and legal medical practice in the United States. A few examples of OLDU include:
- A drug being approved to treat one disease but prescribed to treat another
- A drug being prescribed in a different way than it is approved, e.g. being taken as a capsule rather than used as a topical cream
- A drug being prescribed in a different dosage than approved
Why would a medical provider prescribe something outside of its intended use? A healthcare professional may prescribe off-label drugs to treat a condition because an approved drug may not exist or all approved treatment options have been exhausted.
According to the Agency for Healthcare Research and Quality, one in five prescriptions is written off-label. Although OLDU is both legal and common, the FDA does not regulate this practice, nor does it deem a drug to be safe outside of its approved uses.
OLDU happens in every medical practice specialty. According to a report in the Mayo Clinic Proceedings, it is more common for pediatric, pregnant, and psychiatric patients because those populations are not as likely to participate (or be well represented) in clinical trials. Therefore, fewer approved drugs exist for these categories of patients.
Another common characteristic of off-label use is that generic drugs are the ones most often prescribed off-label. This is because the longer a drug is on the market, the more new uses for it are found. Every drug approved by the FDA goes through an extremely rigorous, costly, and time consuming approval process. It is cost- and resource-prohibitive to go through this process again for a drug that is generic and will not generate the profits it did as a name-brand drug.
While the practice of OLDU is legal, it is illegal for pharmaceutical companies to market drugs for off-label use. Therefore, doctors rely on other sources for information about off-label uses for drugs and what types of patients might benefit from these uses.
The Importance of Informed Consent for Off-Label Use
Informed consent is extremely important when drugs are prescribed off-label. Informed consent is the voluntary and informed decision a competent patient makes about whether to accept or refuse a treatment after a medical provider discloses all pertinent information about the given treatment.
While informed consent is important in any medical situation, it is vital for OLDU. The FDA does not regulate this medical practice, and the Food, Drug, and Cosmetic Act of 1938 does not create physician liability (nor does any other law), according to a report in the Mayo Clinic Proceedings. Prescribing off-label drugs could subject a physician to liability in the case of medical negligence, but it does not mean he or she will be held liable for nondisclosure.
This same report indicates that if a patient thinks he or she has been harmed by the prescription of an off-label medication, he or she must prove that the prescribing physician did not follow the standard of practice when prescribing the medication. This can be difficult to prove because the FDA does not allow drug manufacturers to educate physicians for off-label use of their drugs. The manufacturers can, however, respond to questions and distribute peer-reviewed publications about OLDU. These responses must come from the medical affairs office of the drug manufacturer (not a sales representative), and these interactions must be well documented.
Potential Implications of Using Off-Label Medications
OLDU is extremely complicated and lacks a foundation of reliable, medically accurate, and accountable information. While some patients can benefit from off-label use, others may be harmed—or even killed—by it. Further complicating the issue is the possibility that a physician can be financially incentivized by pharmaceutical manufacturers for prescribing certain drugs off-label without fully considering the patient’s unique circumstances or determining if the patient could experience unknown adverse side effects from OLDU.
Whatever the situation, make sure you are well informed and empowered in all your medical decisions.
And if you are ever faced with the option of using a drug off-label, the FDA encourages patients to be strong advocates for themselves. They recommend asking the following questions:
- What is the drug approved for?
- Are there other drugs or therapies that are approved to treat my disease or medical condition?
- What scientific studies are available to support the use of this drug to treat my disease or medical condition?
- Is it likely that this drug will work better to treat my disease or medical condition than using an approved treatment?
- What are the potential benefits and risks of treating my disease or medical condition with this drug?
- Will my health insurance cover treatment of my disease or medical condition with this drug?
- Are there any clinical trials studying the use of this drug for my disease or medical condition that I could enroll in?
Crosley Law Firm: Advocating for Victims of Off-Label Drug Use
Have you or a loved one been negatively affected by off-label drug use? Crosley Law Firm is an experienced legal advocate for individuals suffering from the adverse effects of off-label drugs, bad pharmaceuticals, and defective and recalled medical devices. Our attorneys can review the details of your case during a free consultation and help you decide what your best course of action is. They will be able to help you navigate the complex legal and medical landscape, and they will fight to get the justice and compensation you deserve. Call our offices today at (210) 354-4500 or fill out our convenient online contact form to schedule your free consultation.
Off-label drugs: What you need to know. (2015, September). Agency for Healthcare Research and Quality. Retreived from: http://www.ahrq.gov/patients-consumers/patient-involvement/off-label-drug-usage.html
Ten common questions (and their answers) about off-label drug use. (2012 October). Mayo Clinic Proceedings. Retreived from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/
Understanding unapproved use of approved drugs “off label.” (2016, June 2). U.S. Food & Drug Administration. Retreived from: http://www.fda.gov/ForPatients/Other/OffLabel/default.htm
What is off-label drug use? (2015, March 17). American Cancer Society. Retreived from: http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/chemotherapy/off-label-drug-use
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