OBJECTIVES: To understand US payer and manufacturer experiences with Section 114 of the Food and Drug Administration (FDA) Modernization Act of 1997 (FDAMA 114) and how this experience could influence implementation of new legal provisions and FDA guidance on healthcare economic information (HCEI). METHODS: Payers and manufacturers completed surveys assessing the importance of HCEI and application of FDAMA 114 prior to changes resulting from implementation of 21^st Century Cures and recent draft FDA guidance. RESULTS: Payers (N=59) were largely from managed care organizations (75%) and most (64%) were voting Pharmacy and Therapeutics Committee members. Manufacturers (N=81) represented small- to large-sized companies, with representation primarily from Health Economics and Outcomes Research functions (35%). Most payers (54%) had a person/group responsible for HCEI, with 46% conducting in-house HCEI evaluations. Nearly half (49%) reported that formulary decision-making was at least somewhat limited by the amount and type of HCEI shared by manufacturers; 56% reported receiving HCEI only sometimes or rarely and 29% agreed very much or completely that conservative action by manufacturers limits HCEI access. Some payers (42%) noted variation among manufacturers with respect to proactive sharing of HCEI. Similarly, most manufacturers (53%) rated FDAMA 114 decisions within a brand/ therapeutic area as only somewhat consistent. Approximately half of payers rated real world observational studies comparing adherence rates (47%) and retrospective studies assessing quality measure achievement (58%) as very or extremely useful for informing formulary or medical policy decisions. However, manufacturers reported that it is very or extremely difficult to gain approval for proactive dissemination of these studies (38% and 32%, respectively). CONCLUSIONS:  Despite its utility in payer decision-making, availability and communication of HCEI by manufacturers is varied and limited. Recent approval of 21st Century Cures and draft FDA guidance may improve the effective exchange of HCEI. This research may help to influence implementation of these changes.