FDA efforts to advance medical product communications to support drug competition and value-based health care
FDA Commissioner Scott Gottlieb, MD, reports the FDA is working to provide clear guidance to drug companies about open, responsible communication with payors, formulary committees, and others.
FDA Commissioner Scott Gottlieb, MD, reports the FDA is working to provide clear guidance to drug companies about open, responsible communication with payors, formulary committees, and others. The agency is issuing updated, final guidance documents that provide increased clarity about its thinking and recommendations for some medical product communications. Gottlieb notes the guidance will "inform market participants developing contracts that include value-based arrangements how to communicate information about how a drug might impact outcomes that are important to purchasers like a health plan or hospital, but is not an endpoint that is expressly described in the drug's approved labeling." The first guidance, "Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions and Answers," addresses common questions about companies' communications to payors, recognizing that payors are looking for a range of information about the effectiveness, safety, and cost-effectiveness of approved/cleared medical products. The second guidance, "Medical Product Communications That Are Consistent With the FDA-Required Labeling," includes the FDA's views on manufacturers' communication of information that is not contained in the FDA-required labeling for their products, but that is consistent with that labeling. "Together, 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," Gottlieb says.