January 26, 2017
Authored and Edited by Jon T. Self, Ph.D.; Mark J. Feldstein, Ph.D.
On January 25, 2017, FDA released a nonbinding draft Guidance for Industry, Medical Product Communications that are Consistent with the FDA-Required Labeling—Questions and Answers.
FDA intends the Guidance to help makers of medical products—as well as packers, distributors, and representatives—steer clear of trouble when producing/sharing promotional materials and the like that cover information not found in the FDA-required labeling. Here, the term “medical products” encompasses drugs, biologics, and medical devices for people, as well as drugs for animals.
Let’s assume that you make, pack, or distribute an FDA approved drug that is going on the market with FDA-required labeling. Q: Can your promotional materials do more than just parrot the required labeling? A: Yes--as long as what you say is consistent, truthful, and non-misleading compared to the FDA-required labeling.
Allowing for “truthful and non-misleading” promotional materials that go beyond the label, as the Guidance provides, echoes Amarin Pharma, Inc. v. FDA, where the FDA was preliminarily enjoined from blocking “truthful and non-misleading speech promoting the off-label use of” Amarin’s Vascepa® product. 119 F. Supp. 3d 196, 237 (S.D.N.Y. 2015).
The Guidance provides a variety of examples of what would and would not be alright to do when sharing information about your medical product. Here’s a distilled version of several dos and don’ts:
DO Compare your drug’s safety to a competitor’s approved for the same indication;
DO Share feedback from targeted patients using your drug for an approved indication;
DO Tout the convenience of your drug’s approved dosing schedule;
DO Paint a fuller picture of how your drug works in the body;
DO NOT Discuss use of your drug to treat a disease it’s not approved for treating;
DO NOT Suggest your drug can treat a different disease stage than it’s approved for;
DO NOT Talk about using your drug by itself when it’s only approved for combo therapy.
In sum: when preparing and sharing information about your medical product (whether drug, biologic, or medical device), keep the FDA-required labeling in mind. And then keep it consistent, truthful, and non-misleading.
combination product, drugs, veterinary pharmaceuticals, FDA Guidance, Food and Drug Administration (FDA)
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