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The next forum for unraveling FDA off-label marketing rules: State and federal legislatures
Under United States law, physicians can legally prescribe drugs for indications that the Food and Drug Administration (FDA) has not approved ("off-label" uses), but pharmaceutical manufacturers cannot proactively promote their products for such uses. This prohibition comes with exceptions called "safe harbors–" for example, distribution of published article reprints—permitting exchange of knowledge considered valuable by the FDA.
In 2012, the U.S. Court of Appeals for the Second Circuit ruling in U.S. v. Caronia expanded these safe harbors within that court's jurisdiction, allowing manufacturers to engage in "truthful and non-misleading" off-label promotion, a standard far less rigorous than FDA approval. The FDA did not appeal this decision, which was considered a win for drugmakers.
In this May Editorial, Michael S. Sinha and Aaron S. Kesselheim describe the changing legal landscape in the aftermath of the Caronia decision, including efforts by state and federal legislators to provide even greater latitude and regulatory shifts at the FDA.
Image Credit: Jamie, Flickr
Citation: (2018) PLoS Medicine Issue Image | Vol. 15(5) May 2018. PLoS Med 15(5): ev15.i05. https://doi.org/10.1371/image.pmed.v15.i05
Published: May 31, 2018
Copyright: © 2018 Jamie, Flickr. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Under United States law, physicians can legally prescribe drugs for indications that the Food and Drug Administration (FDA) has not approved ("off-label" uses), but pharmaceutical manufacturers cannot proactively promote their products for such uses. This prohibition comes with exceptions called "safe harbors–" for example, distribution of published article reprints—permitting exchange of knowledge considered valuable by the FDA.
In 2012, the U.S. Court of Appeals for the Second Circuit ruling in U.S. v. Caronia expanded these safe harbors within that court's jurisdiction, allowing manufacturers to engage in "truthful and non-misleading" off-label promotion, a standard far less rigorous than FDA approval. The FDA did not appeal this decision, which was considered a win for drugmakers.
In this May Editorial, Michael S. Sinha and Aaron S. Kesselheim describe the changing legal landscape in the aftermath of the Caronia decision, including efforts by state and federal legislators to provide even greater latitude and regulatory shifts at the FDA.
Image Credit: Jamie, Flickr