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FDA Issues Draft Guidance on Distributing New Risk Information for Approved Drugs and Biologics

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In June 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance for the distribution of new risk information for approved prescription drugs to healthcare professionals and healthcare entities. The draft guidance, entitled Guidance for Industry Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices, establishes a limited safe harbor whereby manufacturers of prescription drug or biological products may distribute new risk information that may be inconsistent with the risk information contained in the product’s approved labeling.

The FDA issued the draft guidance to clarify and solicit public comments on its position on manufacturer dissemination of new risk information regarding lawfully marketed drugs for approved uses.  The draft guidance defines “new risk information” as “information that becomes available after a drug is marketed that rebuts or mitigates information about a risk already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 or otherwise refines risk information in the approved labeling in a way that does not indicate great seriousness of the risk.”  The proposed guidance specifically 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 identified in approved labeling is more serious than reflected in the labeling.”

In setting forth the criteria for distribution of new risk information, the FDA recognized 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.   By this publication, the FDA indicates the circumstances under which manufacturers may distribute new risk information even if such data is not consistent with the currently approved labeling. In establishing this draft guidance, the FDA does not intend to object to the distribution of new risk information that rebuts, mitigates or refines risk information in approved labeling and is distributed in the form of a reprint or digital copy, so long as the study or analysis and manner of distribution meet the criteria – concerning data source and distribution – established below:

Data Source:

  • The study or analysis of the risk discussed should meet accepted design and other methodologic standards for the type of study or analysis and be sufficiently well-designed and informative to merit consideration;
  • the study or analysis should be at least as persuasive as the data that underlie the existing risk assessment reflected in the approved labeling;
  • The conclusions of the study or analysis should give appropriate weight and consideration to all relevant information in the safety database, including contrary or otherwise consistent findings; and
  • The study or analysis should be published in an independent, peer-reviewed journal.


  • The reprint or digital copy should be accompanied by a cover sheet that clearly and prominently discloses:
    1. The study design, critical findings, and significant methodological limitations that may limit the persuasiveness of the findings
    2. That the information is not consistent with certain risk information in the approved labeling
    3. That FDA has not reviewed the data; and
    4. Any financial interests or affiliations between the study author(s) and the 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; and
  • Any statements made by a manufacturer’s representative concerning the new risk information should be consistent with the content and the information in the disclosure cover sheet.

The guidance can be found at

Comments to the FDA concerning the draft guidance can be submitted electronically at and should be submitted no later than August 20, 2014.