Drugmakers Await FDA Guidance on "Off-Label" Uses of Medicines

Drugmakers Await FDA Guidance on "Off-Label" Uses of Medicines
Tommy Farmer/Tennessee Bureau of Investigation via AP

Doctors commonly prescribe drugs to treat conditions the medications weren't designed for, but for drugmakers, discussing such "off-label" uses can lead to trouble. 

As a result, drugmakers have been pushing both the Food and Drug Administration and lawmakers to draw clearer lines around communicating about unapproved uses of their products, particularly since it affects what companies can tell insurers. Such information is used to negotiate prices for covered medical products and their place in certain payment models. 



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