How to Deal with Off-Label Information: New FDA Guidance With Old Info

Ten years ago, the FDA published a guidance document about its opinion on what manufacturers should do when they become aware of independently generated off-label information about their approved products. This week, the FDA published an update to that guidance with similar info but with more examples and scenarios, which reemphasizes the voluntary nature of a firm’s response to such off-label information in ways that would be compliant with FDA’s expectations.?

Off-label information is an important part of medical practice and patient care. Doctors can prescribe a product for pretty much any indication that they believe would help their patients. Such off-label prescriptions add to the revenue of the manufacturers. While the FDA does not regulate how doctors write prescriptions, it does control how prescription products are promoted. Firms are not allowed to promote their products for off-label uses. So, how does a firm navigate the market where both on-label and off-label information about their products could impact how these products are used? The key is how the off-label information is generated.?

Per the FDA enforcement policy, firms are not liable for independently generated off-label information. Further, they can “choose” to voluntarily respond to such off-label information to attempt to correct it. Not being liable protects the company from off-label information that it had no hand in producing or distributing. In the ten years since the initial guidance, thanks to social media, off-label information is widely available. The new FDA guidance presents several scenarios where independent third parties may create false, inaccurate, and misleading information about prescription products. In all the cases, the FDA clarifies that the firm can “choose” to respond, not that it “must” respond. The guidance goes on to provide advice about the way to respond so that the firm stays compliant. Namely to be specific, scientifically sound, balanced, truthful, and non-misleading.?

This is not a new advice. Firms can continue their current practice of responding to off-label information that they become aware of if it suits their interests. As a general practice, firms simply stay silent for information that is helpful to their sales but respond vigorously if it’s the other way around. That is perfectly ok with the FDA.