2015 Was Another Good Year for Orphan Drugs & Pharma Marketers

UPDATED 4 Jan 2016: FDA approved 45 new drugs in 2015, four more than in 2014 and the highest number since 1996. Twenty-one (21) of those (47%) were "orphan" drugs (find FDA data here). This compares to 17 orphan drugs approved in 2014 or 41% of the total (see CDER New Drug Review: 2015 Update and "2014 Was a Good Year for FDA & Pharma").

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That's good news for the pharma industry, which often submits drugs to the FDA as orphan drugs but once approved the drugs are "used broadly off-label with the lucrative orphan drug protections and exclusivity benefits," according to the authors of a study recently published in the American Journal of Clinical Oncology (read "#Pharma Welfare: 'Orphan' Blockbuster Drugs on Rise - Including Crestor!").

Pharma marketers also have good news regarding FDA marketing enforcement actions in 2015.

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