Life Science Compliance Update

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January 26, 2017

FDA Releases Draft Guidance on Manufacturer Communications with Payors, Formulary Committees, and Similar Entities

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In mid-January 2017, the United States Food and Drug Administration (FDA) released a guidance document, entitled Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities – Questions and Answers,” explaining FDA’s current thinking regarding communications by medical product manufacturers, packers and distributors of health care economic information (HCEI) about approved prescription drugs to payors and formulary committees.  The draft guidance also provides answers to common questions about dissemination of information by firms regarding investigational drugs and devices to payors before FDA clearance or approval of those products.

HCEI is defined in the document as “any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or compromising the analysis) that identifies, measures, or describes the economic consequences of the represented health outcomes, of the use of a drug.” HCEI pertains to the economic consequences related to the clinical outcomes of treating a disease (or specific aspect of a disease) or of preventing or diagnosing a disease. According to the FDA, HCEI may be presented in a variety of ways that can include, but are not limited to, an evidence dossier, a reprint of a publication from a peer-reviewed journal, a software package comprising a model with user manual, or a budget-impact model.

HCEI is not to be considered false or misleading if, among other things, it “relates to an [approved] indication.” To be considered related to an approved indication, HCEI analyses should relate to the disease or condition, manifestation of the disease or condition, or symptoms associated with the disease or condition in the patient population for which the drug is indicated in the FDA-approved labeling. Pages six through eight of the guidance have a table of HCEI analyses that relate to the approved indication.

In the guidance document, FDA defines “payors” as including payors, formulary committees, or other similar entities responsible for making drug selection, formulary management and/or coverage and reimbursement decisions regarding drugs and/or devices for health care organizations, including integrated health care delivery networks, hospitals and hospital systems.  In the guidance, FDA notes that if a firm disseminates HCEI about an approved drug consistent with the guidance, when finalized, FDA does not intent to consider such information false or misleading or as providing evidence of a new intended use.

In an accompanying Federal Register notice, FDA announced that it is reopening the comment period related to a previous public hearing concerning manufacturer communications regarding unapproved uses of approved or cleared medical products. This comment period will be reopened for 90 days, beginning January 19, 2017.

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