The American Association of Neurological Surgeons and National Association of Spine Specialists — along with several other specialty organizations — signed a letter to the FDA outlining recommended practices for distributing scientific and medical publications on unapproved new uses for medical devices.
The FDA recently released "Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices." The societies authoring the letter expressed concern about the guidance and send Assistant Commissioner for Policy Leslie Kux a copy of the Alliance of Specialty Medicine position statement on physician-directed applications.
Here are five things to know about the controversy:
1. The FDA issued guidance on how device manufacturers could distribute journal articles and scientific or medical reference publications in 2009. This recent revision clarifies the FDA's position on manufacturer dissemination of these materials for unapproved new uses of the manufacturer's FDA-cleared products:
"Under the FD&C Act, an approved new drug that is accompanied by written, printed or graphic matter that suggests an unapproved use may be an unapproved new drug with respect to that use. Furthermore, an approved prescription drug that is intended for an unapproved use (whether referenced in labeling or not) would be considered misbranded, because the drug does not meet the regulatory exemptions from the requirement that it's labeling bear 'adequate directions for use.' Similarly, a medical device that is intended for an unapproved use is considered adultered and misbranded."
2. The Revision is just a draft released for comment at this time, not for implementation. The draft contains nonbinding recommendations. The revision was created in response to stakeholder questions about its application to scientific and medical reference texts and CPGs that include information on unapproved uses and goes on to state:
"Consistent with longstanding FDA policy and practice, if manufacturers distribute scientific or medical publications as recommended in this guidance, FDA does not intend to use such distribution as evidence of the manufacturer's intent that the product be used for unapproved new use."
3. The revision provides guidance on scientific or medical journals, scientific or medical reference texts and clinical practice guidelines.
• For scientific or medical journals, the guidelines recommend the articles are peer reviewed, unabridged in the reprint, disseminated with approved labeling and comprehensive bibliographies and distributed separately from the delivery of promotional information for the company, in addition to other recommendations.
• In scientific and medical reference texts, the guidance recommends dissemination should be based on systematic review of the evidence, the most current version of the text, published by an independent publisher, peer-reviewed and sold through usual and customary independent distribution channels.
• Clinical practice guidelines were recommended to at minimum be developed by a multidisciplinary panel of knowledgeable experts, consider patient subgroups and preferences, disseminate transparent and the current version separately from other promotional material.
4. The Alliance of Specialty Medicine letter states that delivering truthful, non-misleading scientific information on medically-accepted alternative uses of medical products is "not viewed as promotional by our organizations." The Alliance's position statement supports the dissemination of these materials if there is prominent disclosure that the FDA hasn't approved the use. The societies are concerned the new position statement will restrict access to scientific information that could improve patient care and drive innovation in clinical practice.
5. The guidance offers recommendations on what manufacturer's "should" and "should not" do; however, the use of "should not" doesn't create independent legal prohibition. The guidance does not establish legally enforceable rights or responsibilities. Stakeholders are able to submit comments on the guidance.
More Articles on Spine Surgery:
5 Key Results of LDR's Mobi-C Artificial Disc Replacement vs. ACDF
5 Things to Know About the NuVasive-Cadwell Lawsuit Resolution
The Making of an Interactive Spine Registry: Dr. Zoher Ghogawala