Right-to-try bill introduced in House

On Monday, Reps. Andy Biggs (R-Ariz.) and Brian Fitzpatrick (R-Penn.) introduced right-to-try legislation in the U.S. House of Representatives. The bill includes a safe harbor provision which would prevent FDA from considering adverse events tied to administration of unapproved drugs to terminally ill patients under compassionate use. The bill would prohibit the federal government from using data or experiences from compassionate use "to delay or otherwise adversely impact review or approval" of a drug or device.

The Right to Try Act of 2017 would also create liability protection for companies that provide access to unapproved drugs under compassionate use. The bill would prevent FDA from prohibiting or restricting access to unapproved drugs to treat terminal illnesses if a Phase I trial has been completed and the product "remains under investigation in a clinical trial" approved by FDA...