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
Editorials
All science should inform policy and regulation
PLOS Medicine: published May 3, 2018 | https://doi.org/10.1371/journal.pmed.1002576
The next forum for unraveling FDA off-label marketing rules: State and federal legislatures
PLOS Medicine: published May 8, 2018 | https://doi.org/10.1371/journal.pmed.1002564
Research Articles
Health insurance coverage with or without a nurse-led task shifting strategy for hypertension control: A pragmatic cluster randomized trial in Ghana
PLOS Medicine: published May 1, 2018 | https://doi.org/10.1371/journal.pmed.1002561
Public versus internal conceptions of addiction: An analysis of internal Philip Morris documents
PLOS Medicine: published May 1, 2018 | https://doi.org/10.1371/journal.pmed.1002562
Association of vitamin D with risk of type 2 diabetes: A Mendelian randomisation study in European and Chinese adults
PLOS Medicine: published May 2, 2018 | https://doi.org/10.1371/journal.pmed.1002566
Access to antiretroviral therapy in HIV-infected children aged 0–19 years in the International Epidemiology Databases to Evaluate AIDS (IeDEA) Global Cohort Consortium, 2004–2015: A prospective cohort study
PLOS Medicine: published May 4, 2018 | https://doi.org/10.1371/journal.pmed.1002565
Distributional change of women’s adult height in low- and middle-income countries over the past half century: An observational study using cross-sectional survey data
PLOS Medicine: published May 11, 2018 | https://doi.org/10.1371/journal.pmed.1002568
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PLOS Medicine: published May 25, 2018 | https://doi.org/10.1371/journal.pmed.1002572