On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This draft guidance was issued as one of a series of actions taken by the Agency in the final days of the Obama Administration. The draft guidance creates a new safe harbor, expressly permitting manufacturers to disseminate certain information about investigational products to payors prior to approval or clearance. The draft guidance also clarifies how FDA interprets the healthcare economic information (HCEI) provision of Section 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (formerly referred to as FDAMA 114, and recently amended by Section 3037 of the 21st Century Cures Act).
New Safe Harbor for Certain Pipeline Communications to Payors -
The most significant aspect of the draft guidance is the new safe harbor for limited pre-approval communications with payors regarding investigational drugs and devices. Due to payor demands for pipeline information for planning purposes, many companies have engaged in a limited manner with payors prior to approval, but without clear guardrails or FDA sanction. This draft guidance is the first time that FDA has expressly granted permission for such exchanges. Now, communications disseminated in compliance with the draft guidance will not be considered violations of the prohibition on promotion of an investigational product in 21 C.F.R. §§ 312.7(a) and 812.7(a).
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