Off-label Drug Use: Fact vs. Fiction

The authors – CM Wittich, CM Burkle, and WL Lanier – offer a concise review of the topic of off-label drug use including its definition, prevalence, and implications for drug safety.   The article format addresses 10 common questions and their answers...

Orphan Drug Development: Midsize to Large Company Perspectives

Rare diseases can be described in terms of incidence, etiology, morbidity, and survival.  Incidence can vary, however, from rare (e.g., Gaucher disease, cystic fibrosis) to epidemic proportions (e.g., HIV, malaria, cholera).  The incidence of less frequently occurring...

Precedent-setting Lawsuit: Free Speech vs. Off-Label Drug Promotion

Allergan, the maker of Botox, is suing the federal goverment by asserting that marketing restrictions prevent the company from communicating practical medical information — like patient selection criteria or optimal dosing patterns — to doctors that could reduce the...