FDA issues guidance for off-label communications for drugs & devices

The FDA issued 2 draft guidances today to clarify the federal watchdog’s recommendations for communications regarding medical products, including off-label information and communicating cost-effectiveness data to payors for investigational drugs and devices that are not yet approved for use.

“Medical product firms have told FDA that they are interested in communicating, including in their promotional materials, data and information about the approved/cleared uses of their products that are not contained in their products’ FDA-required labeling,” the FDA wrote in its ‘Medical Product Communications that are Consistent with the FDA-Required Labeling‘ draft guidance. “We also recognize that firms have questions about how FDA determines when communications that contain data and information that are not in the FDA-required labeling are consistent with the FDA-required labeling, and how such communications are viewed by FDA.”

While the FDA determines what information appears on the labels of drugs and devices, drugmakers have pushed to communicate information that isn’t on the label but is relevant to the approved use of the product.

If a drug or device-maker communicates information off-label that has not been evaluated by the FDA, but it appears to have been, it could lead to misbranding and the firm could be subjected to enforcement action if the information is considered false or misleading.

The FDA wrote that companies should disclose why the additional, off-label data is relevant, in order to ensure that the company conveys information that is consistent with FDA-required labeling in a truthful way.

The federal watchdog provided a few examples of information that would not be considered consistent with FDA-required labeling, including information about the use of a product to treat or diagnose a different disease or a different patient population than the product is approved to treat.

The FDA’s 2nd draft guidance, ‘Drug and Device Manufacturer Communications with Payors’, detailed how firms should go about providing cost-effectiveness, safety and efficacy data to payors.

“Payors seek a range of information on effectiveness, safety, and cost-effectiveness of approved prescription drugs, including information from firms, to help support their drug selection, formulary management, and/or coverage and reimbursement decisions on a population basis. Often, this information differs from and can be provided in addition to the information FDA reviews in order to make approval decisions. Because coverage and reimbursement decisions by payors impact a large number of patients, FDA believes it is essential that information provided by firms to payors about their drugs be truthful and non-misleading,” the federal group wrote. “Payors have also indicated that due in part to their need to, in some situations, plan for and make coverage and reimbursement decisions far in advance of the effective date of such decisions, they are also interested in receiving information from firms about medical products that are still under investigation or review by FDA.”

To ensure that payors make informed coverage and reimbursement decisions, the FDA said, companies should provide them with the appropriate background and contextual information to help them fully understand the health care economic information.

The FDA wrote that health care economic information can be given to a payor, formulary committee or similar entity for the selection of drugs for coverage or reimbursement. However, the guidance doesn’t apply to dissemination of that information to individual health care providers making patient prescribing decisions or consumers.

“We recognize that there is a high level of interest regarding FDA’s views on communications about medical products. We are committed to an ongoing dialogue with industry and other stakeholders, and, when needed, providing guidance to clarify the agency’s thinking on these issues,” FDA commissioner Dr. Robert Califf wrote in a statement.

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