Editor’s Perspective

Facts About Prescribing Off-Label

May 1, 2020

By Dwight Akerman, OD, MBA, FAAO
Chief Medical Editor, Review of Myopia Management

Many eye care professionals are hesitant to prescribe contact lenses or pharmaceutical agents because they do not have an FDA labeling indication for slowing progressive myopia in children. Reasons for this hesitation include unfamiliarity with FDA regulations and uneasiness with explaining to parents why they are prescribing a product off-label.

To date, the CooperVision MiSight® 1 Day Contact Lens is the only product to receive an FDA labeling indication for slowing the progression of myopia in children. However, eye care professionals specializing in myopia management routinely prescribe off-label a wide variety of products, depending on the needs of an individual child.

The FDA does not regulate the practice of medicine. Title 21, Chapter 9, Section 396 (Practice of Medicine) of the Federal Food, Drug, and Cosmetic Act specifically addresses the practice of medicine and off-label prescribing.1

  • 396. Practice of medicine

“Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.”

Therefore, the practitioner-patient relationship allows off-label prescribing of medical devices and drugs for any condition or disease within a legitimate health care practitioner-patient relationship. The FDA prohibits practitioners from marketing or promoting off-label uses of approved products.

Before prescribing a product off-label, practitioners should be well informed from peer-reviewed scientific and medical evidence. Be sure to have the parent or guardian of the child sign an informed consent before initiating off-label treatment. And finally, keep detailed records on what you have prescribed and the efficacy of that off-label product.

Undoubtedly, myopic children will benefit from off‐label prescribing supported by sound scientific and medical evidence.

Best professional regards,

 

 

 

Dwight H. Akerman, OD, MBA, FAAO, FBCLA
Chief Medical Editor
dwight.akerman@gmail.com

 

1 Federal Food, Drug, and Cosmetic Act. Retrieved on April 17, 2020

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