US FDA issues guidance on new risk information dissemination

Late last Friday afternoon, the US Food and Drug Administration issued a new guidance document describing the agency’s recommended practices for distributing reprints that convey new risk information for approved drug and biologic products, reports Anne Walsh writing on Hyman, Phelps & McNamara’s FDA Law Blog.

The guidance defines “new risk information” as information that becomes available after a drug is marketed that rebuts or mitigates information about a risk already identified in the approved labeling. This term does not include information about a newly identified risk that was not previously included in the approved labeling, or new information that indicates that a risk is more serious than reflected in labeling. The FDA acknowledges the value of quickly disseminating this type of information to health care professionals: “FDA recognizes that the safety profile of a drug evolves throughout its lifecycle as the extent of exposure to the product increases and that it can be helpful for health care practitioners to receive significant new risk information about an approved product in a timely manner,” it stated.

Differs from “new uses” of products