Restrictions on Off-Label Prescribing?

A colleague recently brought to my attention a New England Journal of Medicine (NEJM)¹ article describing a federal effort to stop off-label prescribing. The email subject line read “Using FDA Law to Threaten Medical Practice.” My colleague was concerned about what this would mean for our patients. I was not worried, being leery of such claims and knowing it is important to look at the details.

Off-label prescribing is widespread in dermatology and in so many other areas of medicine. Spironolactone for acne. Anything other than topical steroids for lichen planus. Ending off-label prescribing would hamstring our ability to care for patients. In what may have been the most difficult project I ever assigned to a medical student, off-label prescribing for the leading 10 dermatologic conditions varied from 17% to 73%.²

You can get a sense of how ubiquitous off-label prescribing is just by opening this issue of The Dermatologist. In our cover story, Dr Oyetewa Asempa describes the management of hyperpigmentation, which includes sun protection and the first-line treatment of hydroquinone, a topical steroid, and a retinoid. There are at least a couple of off- label treatments right there. Not to mention oral tranexamic acid, cysteamine, acitretin, and dapsone.

Also in this issue, gastroenterologist Dr David Fudman discusses inflammatory bowel disease (IBD) in dermatologic practice. Two dermatologic conditions associated with IBD are erythema nodosum and pyoderma gangrenosum. We have several treatments for those conditions; all are off label.

Will the government criminalize electronic off-label prescribing and put our paper prescription pads in handcuffs? I think not. The NEJM article offered a perspective on how the federal government claims off-label prescribing should not be permitted for gender-affirming care. The government is not preoccupied with our prescribing spironolactone or other drugs off label. Moreover, the US Food and Drug Administration approves drugs but does not regulate the practice of medicine. Regulating the practice of medicine is done at the state level, and courts have already rejected federal control of on- vs off-label use when it has been challenged.