FDA Guidance for Industry
Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices” is available.
This draft guidance describes the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on recommended practices for drug manufacturers (firms) and their representatives to follow if they choose to distribute to health care professionals or health care entities scientific or medical journal articles that discuss new risk information for approved prescription drugs marketed in the United States. The recommendations in this draft guidance are intended to address issues specific to the distribution of new information about risks associated with a drug that further characterizes risks identified in the approved labeling.
The recommendations in this draft guidance are intended to apply to distribution of new risk information (as that term is further explained in section II of this document) for drugs intended for human and animal use. Throughout this draft guidance, the Agency provides references to regulations and guidances specific to drugs intended for human use. Unless otherwise indicated, the Agency generally takes a similar approach when addressing the issues raised in this draft guidance as they pertain to animal drugs.
FDA’s guidance documents, including this draft guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Before distributing new risk information that suggests that an adverse reaction or other risk currently in approved labeling is not causally related to a drug or is less consequential than is reflected in the labeling, or that otherwise refines the characterization of an adverse reaction identified in approved labeling, firms should carefully consider the reliability and persuasiveness of the data.