Off-Label Use vs Off-Label Marketing of Drugs
Open accessAbstract
Once medical drugs and devices are approved for marketing by the FDA they can legally be used for purposes and in ways other than the ones for which they have been tested and approved. However, it is illegal for manufacturers to advertise or promote such unapproved uses of the drugs and devices. Part 1 of this review focuses on off-label use of FDA-approved therapies. Part 2 addresses illegal off-label marketing of drugs and devices. While off-label use can be beneficial to patients, unless carefully undertaken off label use may undermine the important safety mission of the FDA, can expose patients to elevated risks without proven benefits (or possibly no benefit), and can reduce motivation of companies to study the safety and risks of off-label use of therapies. These problems are further amplified when off-label use occurs among very vulnerable patient populations such as the elderly, patients with mental health disorders, pregnant women and pediatric patients. This review considers ethical issues in off-label use, as well as important steps for physicians considering an off-label prescription of a drug or device.
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In the United States, the FDA approves medicines only for specific indications, but physicians are allowed to prescribe them off-label when supported by scientific evidence; commercial promotion of off-label uses by pharmaceutical companies is prohibited.
“Regulatory strategies also differ in the United States; the FDA approves medicines only for specific indications, but physicians are allowed to prescribe them off-label when supported by scientific evidence. The main restriction is the prohibition of commercial promotion of off-label uses by pharmaceutical companies.3”
From Off-label and repurposed use of disulfiram beyond alcohol dependence: A systematic review of clinical and preclinical evidence (2026) · cites this paper as [3]
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Off-label use catalogue of tumor anti-angiogenic drugs in China: a narrative review
Yao, D., Hu, Y., Weng, S., Wang, T., Tao, Z., Liu, L., Luo, H., He, W., & Dai, H. (2025) · Frontiers in Pharmacology · doi:10.3389/fphar.2025.1668620
Fleming, B. C. (2025) · The American Journal of Sports Medicine · doi:10.1177/03635465251396961
Trends in the Use of Antipsychotics for Off-Label Indications: Clinical and Ethical Considerations
Siddique, M. I., Ahmad, S., & khan, A. (2025) · Biomedical & Pharmacology Journal · doi:10.13005/bpj/3273
Prescription Depressant-Involved Overdose Mortality in Massachusetts (2000-2023): A Cohort Study
Lee, H., Dong, H., Jalali, M. S., & Stringfellow, E. J. (2026) · Journal of General Internal Medicine · doi:10.1007/s11606-025-10113-8
Gadaria, S., More, S., Pal, V. S., Mishra, P., Rastogi, P., & Rastogi, D. (2026) · Indian Journal of Pharmacology · doi:10.4103/ijp.ijp_184_25
Takahashi, K., Yokoi, H., Mikami, F., Satomi, T., Morikazu, S. E. K. I., Niwa, T. T., Hanaoka, H., Inaba, Y., & Koide, D. (2026) · Journal of Medical Systems · doi:10.1007/s10916-026-02388-z
Approaches to ketamine-assisted couple therapy
Avruch, D. O. (2026) · Frontiers in Psychology · doi:10.3389/fpsyg.2026.1843151
Valladales‐Restrepo, L. F., Velásquez-Echeverry, M., Castañeda-Orozco, M., Trejos-Gonzáles, S. C., Tapasco-Hernández, Z. D., Cedeño-Ospina, M. P., & Machado‐Alba, J. E. (2026) · Expert Review of Anti-infective Therapy · doi:10.1080/14787210.2026.2699182
Microdosing Tirzepatide in Multi‐Dose Pens: Clinical Individualization, Safety, and Evidence Gaps
Lara, F. V.-O. D. (2026) · Obesity · doi:10.1002/oby.70282
Off-label drug use in children: prevalence, risks, and regulation
Neubert, A. C., & Eberl, S. (2026) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2026.2742318
- Authors
- Van Norman, G. A.
- Venue
- JACC: Basic to Translational Science
- Publisher
- Elsevier BV
- Published
- 2023-02
- Volume
- 8
- Issue
- 2
- Pages
- 224-233
- ISSN
- 2452-302X (ISSN-L)
- PMC
- PMC9998554
- OpenAlex
- W4322489596
- Cited by
- 49
- References
- 58
- Citations by year
- 2026: 12 · 2025: 22 · 2024: 14 · 2023: 1
- FWCI
- 12.93
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- JACC Basic to Translational Science (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- off-label drug use, FDA drug approval, drug safety, vulnerable patients, physician prescribing decisions, drug promotion regulation
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