AdvaMed Submits Payor Communication Comments
AdvaMed’s recent submission to the Food and Drug Administration (FDA) provides comments on the Agency’s revised draft guidance governing communications between drug and device manufacturers and payors, formulary committees, and similar entities.
The letter shows support for FDA’s efforts to incorporate statutory changes recognizing the value of truthful and nonmisleading healthcare economic information, including information about products and uses that have not yet been approved or cleared. AdvaMed® emphasizes that these communications are essential for supporting coverage, reimbursement, and healthcare planning decisions before products enter the market.