The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (Payor Communications Guidance) and Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Medical Products Communications Guidance). These guidances were previously released last year in draft.
The Payor Communications Guidance provides input into manufacturer, packer and distributor (Firms) communication of health care economic information (HCEI) regarding prescription drugs and medical devices (Products) to payors, formulary committees, and similar entities (Payors). The Payor Communications Guidance also addresses common questions related to the dissemination of information to Payors regarding Products not yet approved or cleared for any use by the FDA and unapproved uses of approved/cleared medical products. HCEI is defined as “any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug. Such analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention.”
The Medical Products Communications Guidance provides information regarding how FDA evaluates Product communications by Firms that include information not contained in, but consistent with, the FDA-required labeling for an approved or cleared Product. Among other things, the Medical Products Communications Guidance provides examples of communications that are not consistent with the Product labeling, such as communications that include information related to (i) a different indication than the indications in the Product’s FDA-required labeling; (ii) a patient population not related to the approved patient population provided in the FDA-required labeling; (iii) limitations or directions for handling, preparing, and/or using the Product that are different from those provided in the FDA-required labeling; and (iv) dosage or use regimen, route of administration, or strength(s) that are different from those provided in the FDA-required labeling. Communications that increase the potential for patient harm relative to the information reflected in the FDA-required labeling or where the FDA-required labeling does not provide adequate directions for use to enable a Product to be used safely and effectively under the conditions suggested in the Product communication also are considered by the FDA as inconsistent with the product’s labeling.
The FDA press release announcing the availability of these guidances referenced the Secretary of Health and Human Services (HHS) Alex Azar’s goal of “linking payments for drugs to their value and committed to removing regulatory obstacles to value-based purchasing by payors”, as set forth in the HHS blueprint released last month, and stated that it “can help nurture this change by providing clear guidance to pharmaceutical companies about open, responsible communication with payors, formulary committees and others.” The FDA further stated that it the “ultimate goal is to help facilitate a market that is more competitive” and benefits patients.
Manufacturers should carefully evaluate these guidance documents and consider the implementation or revision of company policies, procedures, and practices that may be impacted. Manufactures also should consider employee training to address permissible and impermissible product communications.