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# 2 Updated Medical Product Communications Guidances
- URL: https://www.fdaweb.com/2-updated-medical-product-communications-guidances/
- Published: 2018-06-12T12:00:00.000Z
- Updated: 2026-09-15T00:12:31.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5141660

As part of its response to efforts to rein in prescription drug costs, FDA has issued two updated final guidances to provide greater clarity about its thinking and recommendations for certain medical product communications. The first [guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537347.pdf?ref=fdaweb.com), *Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions and Answers*, answers common questions about companies’ communications to payors, including insurance companies, formulary committees, and similar entities.

In a [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm610415.htm?ref=fdaweb.com), FDA commissioner **Scott Gottlieb** says the guidance recognizes that payors seek a range of information on the effectiveness, safety, and cost-effectiveness of approved/cleared medical products, including information from drug manufacturers, to help support product selection, formulary management, and/or coverage and reimbursement decisions. Gottlieb says the final guidance was changed based on stakeholder comments to include recommendations that are designed to enable “truthful, non-misleading and appropriate company communications with insurers across a product’s lifecycle.”

The second guidance, *Medical Product Communications That Are Consistent with the FDA-Required Labeling*, [gives](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537130.pdf?ref=fdaweb.com) agency views on manufacturers’ communication of information that is not contained in the FDA-required labeling for their products, but is consistent with that labeling.

“Together,” Gottlieb says, “we believe these two guidances will provide clarity to companies as they develop communications about their medical products and help ensure that patients, providers, and insurers have access to a range of relevant, truthful, and non-misleading information from companies about medical products. The aim of our policy is to help facilitate contracting for new medical products that are based on the value that these products are delivering to health systems, providers, and especially patients. However, these guidances are not intended to address how firms currently provide information to doctors and patients about unapproved products or unapproved uses of approved products.”