As health communicators and representatives of drug manufacturers, we often distribute medical information regarding approved drugs in scientific and medical journals. It is important for us to be aware of FDA recommendations, as they represent the FDA’s view on a topic. While guidance documents are not requirements, they provide useful recommendations for drug manufacturers and their representatives. Following FDA guidance helps our clients to mitigate legal risks and protect patients. In June 2014, the US Food and Drug Administration (FDA) issued draft guidance, Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices, to clarify its view on manufacturer dissemination of new risk information regarding lawfully marketed drugs.

“New risk information” refers to information that:

1) becomes available after a drug is marketed that refutes or mitigates information about a risk that has already been identified in the approved labeling, or
2) refines risk information in the approved labeling in a way that does not indicate greater seriousness of the risk.

“New risk information” does not include:

1) information about a newly identified risk not included in the approved labeling, or
2) new information that indicates that a risk that has already been identified in approved labeling is more serious than is reflected in the approved labeling.

The FDA recognizes that the safety profile of a drug may evolve throughout its lifecycle as patient and healthcare practitioner exposure increases. It is helpful for healthcare practitioners to receive new risk information about an approved product in a timely manner. The FDA believes this guidance is needed to address the range of data sources that are appropriate for distributing new risk information and ensure that new risk information meets standards for reliability and appropriately discloses limitations. It is important that new risk information does not lead to confusion or contribute to patient harm.

The FDA does not object to the distribution of new risk information in the form of a reprint of digital copy of a published study, if the data source and distribution meet the following criteria:

Data Source:

  • The study should meet design and other methodologic standards and should be well-designed and informative.
  • To rebut a prior determination that there is a causal relationship between the drug and the occurrence of an adverse event, the study should be at least as persuasive as the data sources that underlie the existing risk. assessment of causality, severity, and/or incidence of the adverse reaction as reflected in approved labeling
  • Study conclusions should give appropriate weight and consideration to all relevant information.
  • The study should be published in an independent, peer-reviewed journal.

Distribution:

  • guidance-for-industryThe reprint or digital copy should be accompanied by a cover sheet that clearly contains:
    • Study design, critical findings, and significant methodologic or other limitations relevant to the persuasiveness of the findings.
    • A statement that the information is not consistent with certain risk information in the approved labeling.
    • A statement that the FDA has not reviewed the data.
    • Any conflicts of interest between the study author(s) and manufacturer.
  • The reprint or digital copy should be accompanied by the approved product labeling.
  • The reprint or digital copy should be separate from any promotional material.
  • Statements made by a representative of the manufacturer should be consistent with the reprint and cover sheet.

Health communicators and pharmaceutical manufacturers should use recommendations outlined in the FDA’s guidance when communicating new risk information to ensure information is not contradictory and does not cause patients harm. For more information, visit the FDA’s website to read the full guidance.