PhRMA, Eli Lilly, other drug companies push back on FDA’s draft guidance about communicating off-label use

Big Phar­ma is push­ing back on draft guid­ance pub­lished by the FDA this fall that aims to clar­i­fy how drug­mak­ers can com­mu­ni­cate with health­care providers about the un­ap­proved use of ap­proved med­ica­tions.

Off-la­bel use is al­lowed when a health­care provider rec­om­mends it, usu­al­ly be­cause a pa­tient hasn’t re­spond­ed to oth­er treat­ments, an ap­proved drug is not avail­able, or there is no ap­proved ther­a­py. The FDA laid out new rec­om­men­da­tions in Oc­to­ber, re­plac­ing a re­vised draft guid­ance from 2014 that de­scribed best prac­tices for drug com­pa­nies dis­trib­ut­ing sci­en­tif­ic and med­ical pub­li­ca­tions on un­ap­proved prod­ucts.

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