Early Access to Unapproved Medicines in the United States and France

In 2018, President Trump signed a federal “right to try” law, claiming that it would give desperately ill patients earlier access to unapproved medicines, by allowing the patient, doctor, and drug company to arrange for access without federal oversight. Critics of the law argued that it would not meaningfully increase access to experimental medicines, because federal oversight was not the obstacle in the first place. And they were correct. U.S. law already permitted companies to provide terminally ill patients with early access to unapproved medicines.

The problem was instead that companies did not take advantage of this option. This Article offers new insights into U.S. law on early access, as well as the new right-to-try law, by offering a comparative perspective using French law.