The US Food and Drug Administration (FDA) provides guidance to pharmaceutical and medical device manufacturers about distributing information on unapproved uses of their products. In 2009, the FDA released what is commonly referred to as “Good Reprint Practices.“* The FDA recognized that off-label or unapproved uses could be important to the standard of clinical care and to health care providers knowledge.
The guidelines were meant to outline how this information should be disseminated, through what types of publications, and how the information should be qualified. The ultimate goal was to allow companies to share scientific research about unapproved uses without promoting these uses.
Responding to questions raised by drug and medical device companies, the FDA recently released an updated version of this guidance (currently in draft form). In “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” [pdf], several issues are spelled out in more detail from the 2009 version. For instance, there are now separate sections with guidelines for Journal Articles, Reference Texts, and Clinical Practice Guidelines.
In general, the FDA states that all types of scientific literature should:
- Be distributed separately from any promotional literature about the drug/device.
- Be peer-reviewed and/or compiled by trusted experts.
- Be unaltered and delivered in its entirety.
- Include a statement that indicates the drug/device is not currently approved for this use.
The FDA states that the distributed literature should NOT:
- Be false or misleading.
- Be written or published specifically at the request of the drug/device company.
- Be marked or highlighted by the company.
Reference texts should:
- Be the most current version.
- Be authored and/or edited by experts in the subject area.
- Be based on a systematic review of the existing evidence.
In addition to the above, Clinical Practice Guidelines (CPGs) should:
- Consider important patient subgroups and patient preferences.
- Provide a clear explanation of relationships between alternative care options and health outcomes.
- Provide ratings of both quality of evidence and strength of recommendations.
Public comments on the draft guidance should be submitted by May 2, 2014. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. (See the notice in the Federal Register for more details.)
*The official title is “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.” Whew.