Entrepreneurship in Off-Label Drug Prescription: Just What the Doctor Ordered!

    January 2015 in “ Social Science Research Network
    Raymond J. March
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    TLDR The conclusion is that off-label drug use can lead to important medical discoveries and improve patient care.
    The document from January 1, 2015, examines the practice of prescribing off-label drugs by entrepreneurial physicians and pharmaceutical companies, focusing on the development of treatments for impotence and hair loss. It describes how entrepreneurial urologists in the 1980s discovered off-label uses for drugs that could induce erections, leading to the field of sexual pharmacology and the eventual FDA approval of injectable treatments for impotence in 1995 and sildenafil citrate (Viagra) in 1998. For hair loss, the document recounts the discovery of hair growth stimulation by minoxidil, a drug for hypertension, which led to FDA approval for treating male pattern baldness in 1987 and female pattern hair loss later. The document argues that these cases show how the market process can deliver effective treatments more rapidly than the FDA approval process and that off-label drug use has historically improved patient care. It concludes by endorsing the benefits of off-label drug use and prescribing and calls for more research into the impact of pharmaceutical companies on prescribing practices and the use of off-label drugs in children and mental illness treatments.
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