The Food and Drug Administration (FDA) has published two final guidances for industry, that provide greater clarity about the organization’s thinking and recommendations for certain medical product communications.
The first guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities
answers common questions about companies’ communications to payors, including insurance companies, formulary committees and similar entities. It recognises that payors seek a range of information on the effectiveness, safety and cost-effectiveness of approved/cleared medical products, including information from pharmaceutical manufacturers, to help support product selection, formulary management and/or coverage and reimbursement decisions. This information may overlap with, but differ from, the information that the FDA reviews in making regulatory decisions. In addition, taking into consideration the many thoughtful comments from stakeholders on the draft guidance, this final guidance now includes recommendations that are designed to enable truthful, non-misleading and appropriate company communications with insurers across a product’s life cycle.
The FDA-required labeling is the primary tool that communicates the essential information needed for the safe and effective use of a medical product. Therefore, the labeling is subject to content requirements and limitations to help ensure that it effectively communicates information. It’s not intended to exhaustively address all that’s known about a product for its approved or cleared uses. Consequently, there are types of information that are not in the labeling, but that are consistent with the labeling, which medical product companies also may want to share. This information, such as data from post-market studies and surveillance of a product’s approved uses, or additional information from the pre-market studies that were used to support approval of the product, may help inform decision-making regarding patient care.
The FDA believes 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.