Here's how FDA officials think you can legally promote off-label device, drug uses


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The FDA has issued final guidance clarifying what it considers permissible off-label information for device makers and drug companies to convey to potential customers.

A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save money, beyond what the products’ indication with the agency says. They might include data from post-market studies and surveillance of a product’s approved uses, or additional information from the pre-market studies, FDA Commissioner Scott Gottlieb said in a statement. This information might affect a payor’s purchase decisions or serve as the basis for developing value-based contracts.

The first guidance, “Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities—Questions and Answers,” answers common questions about companies’ communications to payors, including insurance companies, formulary committees and similar entities. The second guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling,” explains how manufacturers can share information that is not contained in the FDA-required labeling for their products, but that is consistent with that labeling.

The agency released the guidances in response to many industry questions seeking clarification on what off-label information they would be permitted to share. Promoting off-label use of a medical device or drug has landed companies in legal trouble.

“Our final guidance now includes recommendations that are designed to enable truthful, non-misleading and appropriate company communications with insurers across a product’s lifecycle,” Gottlieb said. “The goal is to advance public health benefits such as increased cost savings from informed and appropriate coverage and reimbursement decisions. In this way, we can help ensure patients have more timely access to cutting-edge medical technologies.”

Giving companies the ability to tell payors about unapproved products or off-label uses of approved products may speed up coverage once FDA gives companies the go-ahead to market the products. The result may save money and improve public health, Gottlieb added. A medtech industry trade group hailed the changes.

“We have long supported medical device communications that are truthful, accurate, scientifically sound and support the overall public health,” said AdvaMed president Scott Whitaker in a statement. The guidances released today support these goals by providing much-needed clarity regarding the appropriate sharing of medical device information with payers and other healthcare entities. We believe such communications are critical to support continued advances in medical technology and high quality, optimal care for patients.”



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