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May 2018

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

Research Articles

Health insurance coverage with or without a nurse-led task shifting strategy for hypertension control: A pragmatic cluster randomized trial in Ghana

Gbenga Ogedegbe, Jacob Plange-Rhule, Joyce Gyamfi, William Chaplin, Michael Ntim, Kingsley Apusiga, Juliet Iwelunmor, Kwasi Yeboah Awudzi, Kofi Nana Quakyi, Jazmin Mogaverro, Kiran Khurshid, Bamidele Tayo, Richard Cooper

Association of vitamin D with risk of type 2 diabetes: A Mendelian randomisation study in European and Chinese adults

Ling Lu, Derrick A. Bennett, Iona Y. Millwood, Sarah Parish, Mark I. McCarthy, Anubha Mahajan, Xu Lin, Fiona Bragg, Yu Guo, Michael V. Holmes, Shoaib Afzal, Børge G. Nordestgaard, Zheng Bian, Michael Hill, Robin G. Walters, Liming Li, Zhengming Chen, Robert Clarke

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

Sophie Desmonde, Franck Tanser, Rachel Vreeman, Elom Takassi, Andrew Edmonds, Pagakrong Lumbiganon, Jorge Pinto, Karen Malateste, Catherine McGowan, Azar Kariminia, Marcel Yotebieng, Fatoumata Dicko, Constantin Yiannoutsos, Mwangelwa Mubiana-Mbewe, Kara Wools-Kaloustian, Mary-Ann Davies, Valériane Leroy, for the International Epidemiology Databases to Evaluate AIDS (IeDEA) Pediatric Working Group

Ibuprofen versus pivmecillinam for uncomplicated urinary tract infection in women—A double-blind, randomized non-inferiority trial

Ingvild Vik, Marianne Bollestad, Nils Grude, Anders Bærheim, Eivind Damsgaard, Thomas Neumark, Lars Bjerrum, Gloria Cordoba, Inge Christoffer Olsen, Morten Lindbæk

Clinical, socioeconomic, and behavioural factors at age 50 years and risk of cardiometabolic multimorbidity and mortality: A cohort study

Archana Singh-Manoux, Aurore Fayosse, Séverine Sabia, Adam Tabak, Martin Shipley, Aline Dugravot, Mika Kivimäki

Child morbidity and mortality associated with alternative policy responses to the economic crisis in Brazil: A nationwide microsimulation study

Davide Rasella, Sanjay Basu, Thomas Hone, Romulo Paes-Sousa, Carlos Octávio Ocké-Reis, Christopher Millett

Complement-activating donor-specific anti-HLA antibodies and solid organ transplant survival: A systematic review and meta-analysis

Antoine Bouquegneau, Charlotte Loheac, Olivier Aubert, Yassine Bouatou, Denis Viglietti, Jean–Philippe Empana, Camilo Ulloa, Mohammad Hassan Murad, Christophe Legendre, Denis Glotz, Annette M. Jackson, Adriana Zeevi, Stephan Schaub, Jean–Luc Taupin, Elaine F. Reed, John J. Friedewald, Dolly B. Tyan, Caner Süsal, Ron Shapiro, E. Steve Woodle, Luis G. Hidalgo, Jacqueline O’Leary, Robert A. Montgomery, Jon Kobashigawa, Xavier Jouven, Patricia Jabre, Carmen Lefaucheur, Alexandre Loupy

Related Articles

Future cost-effectiveness and equity of the NHS Health Check cardiovascular disease prevention programme: Microsimulation modelling using data from Liverpool, UK

Chris Kypridemos, Brendan Collins, Philip McHale, Helen Bromley, Paula Parvulescu, Simon Capewell, Martin O’Flaherty