FDA issues guidance for off-label communication

The FDA issued draft guidance this week clarifying conditions under which drug and medical device makers may provide information on off-label uses.  The draft guidance covers unsolicited requests for off-label information.  An unsolicited request is one not initiated in any form by the drug or device maker (or its affiliates) itself.

For a company's response to nonpublic (one-on-one communication) unsolicited requests, the agency has made the following 7 recommendations:

• Response information should be limited to the requestor and treated as private, one-on-one communication.
• Information should be limited to the scope of the initial question.
• Information should be "truthful, non-misleading, accurate, and balanced."
• Information should be scientific in nature.
• Information should be generated "by medical or scientific personnel independent from sales or marketing departments."
• Information should be accompanied by several documents, including a statement notifying the recipient that FDA has not approved the product for the specific off-label use.
• The responding firm should maintain required records, including any follow-up questions from the requester.

For a company responding in public to public (Web sites, discussion boards, and chat rooms that are created and maintained by people other than the manufacturer or its affiliates) unsolicited requests, FDA makes the following 4 recommendations:

• A firm should respond only to a request about its own named product and is not solely about a competitor's product.
• The firm's response "should be limited to providing [its] contact information and should not include any off-label information."
• Those responding on behalf of the firm should clearly disclose their specific involvement with that firm.
• Responses "should not be promotional in nature or tone."

Public comments and suggestions regarding the draft guidance should be submitted within 90 days its publication.

FDA to exempt certain devices from 510(k) process

The FDA released a guidance that will relax the agency's requirements for 510(k) clearance for some medical devices.

The FDA has identified certain class I and class II in vitro diagnostic and radiology devices that have established safety and effectiveness profiles and for which it intends to exempt from the 510(k) process.

While the FDA proposes and finalizes regulations for the down classification and exemption changes, the agency said it intends to exercise enforcement discretion with regard to 510(k) submission requirements for these devices.