Lack of a US Food and Drug Administration indication should not limit access to appropriate treatment

Reply to “Innovation and off‐label use, the French case and more” by Braillon and Lexchin

“…For instance, the guidelines developed by the American Academy of Dermatology endorse offlabel use of drugs for a number of common diseases including atopic dermatitis, psoriasis and acne. 8 Moreover, according to a policy statement by the American Academy of Pediatrics, "evidence, not label indication, remains the gold standard from which practitioners should draw when making therapeutic decisions for their patients." 9 Responding to critical remarks by Braillon and Lexchin, we also would like to underscore that our review 2 was not meant to encourage doctors to prescribe drugs off-label, or to promote use of investigational drugs (nor does this reply have that objective).…”

Reply to: “Lack of a US Food and Drug Administration indication should not limit access to appropriate treatment”

“…To the Editor: We recently read with great interest Albrecht et al's commentary on how US Food and Drug Administration (FDA) indications limit treatment access. 1 Insurance companies frequently utilize FDA guidelines and drug compendia to dictate treatment coverage; however, these resources are frequently outdated and lacking in scope. 2 We agree that treatment coverage should not be restricted by FDA approval.…”