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The authors reflect on the regulation of off-label promotion of drugs, highlighting the case of pharmaceutical sales representative Alfred Caronia, who promoted sodium oxybate for off-label use. Topics include the clinical trials required by the Food and Drug Administration (FDA) to demonstrate the safety and efficacy of the drugs, the misbranding of non FDA-approved drugs and the guidelines released by the drug and biologics industry for off-label promotion.

The article discusses the breakthrough therapy designation created by U.S. Congress to expedite Food and Drug Administration testing as well as approval of drugs aimed at treating serious diseases. Manufacturers were allowed to employ many programs to combine different advantages which reduced cost of drug development.

The article focuses on several aspects of the Prescription Drug User Fee Act (PDUFA) in the U.S. It mentions that U.S. President Donald Trump signed into law the sixth version of key legislation for the U.S. Food and Drug Administration (FDA), known as the Prescription Drug User Fee Act (PDUFA VI) on August 2017. It also mentions that nonsteroidal antiinflammatory drug rofecoxib (Vioxx) was removed from market when it was found to substantially increase the risk of cardiovascular events.