Another “Good Reprint Practices” Guidance, This Time Specific to New Risk Information

By Anne K. Walsh –

Late last Friday afternoon, FDA issued a new guidance document describing FDA’s recommended practices for distributing reprints that convey new risk information for approved drug and biologic products.  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.  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.” 

In the guidance, FDA emphasizes that the dissemination of new risk information for approved uses of drugs is distinct from the dissemination of information concerning new uses of products, addressed in the February 2014 draft guidance discussed here.  FDA differentiates new risk information from new use information in two ways:

• Because “there are differences in the purpose, nature, and reliability of the evidence used to determine the effectiveness of a drug (e.g., to support a new intended use) and the evidence that is the basis for the product’s risk assessment,” guidance is needed to address the spectrum of appropriate data sources for new risk information; and
• Because health care practitioners may be confused by new risk information that contradicts the information in approved labeling, guidance is needed to ensure new risk information “meets appropriate standards for reliability and is presented with appropriate disclosure of its limitations.”

Therefore, FDA claims that it will not object to the distribution of new risk information if it is distributed in the form of a reprint (or digital copy) of a published study, and if the manufacturer follows certain principles related to the data source and the distribution methods of the reprint.  It should be noted that, unlike the earlier reprint guidance document on new uses, FDA excludes medical devices from the scope of this guidance.  FDA drops this reference in a footnote without further explanation.

The guidance describes a distribution scheme for reprints containing new risk information that is very similar to the distribution of reprints related to unapproved uses.  For example, the reprint must be accompanied by a cover sheet disclosing that FDA has not reviewed the data and any financial interests between the study author and the manufacturer.  The reprint also must be accompanied by the approved product labeling, and cannot be distributed with any promotional material.

But unlike the earlier draft guidance on new uses, the new guidance describes the types of studies or analyses necessary to be assure the reliability and persuasiveness of the data.  For example, FDA will consider whether the conclusions of the study give appropriate weight and consideration to all relevant information in the safety database; whether the study is sufficiently well-designed and informative to merit consideration in assessing the implications of a risk; and whether the study is at least as persuasive as the data sources that underlie the existing risk assessment in the approved labeling.  These criteria appear to introduce a level of subjectivity to the adequacy of the data source.

If a manufacturer meets the requirements of the guidance, FDA claims that distribution of new risk information will not render the labeling false or misleading under 21 U.S.C. § 352(a).

Comments are due within 75 days of publication of the Federal Register notice announcing the draft guidance.