The FDA proposed a new rule July 23 that, if approved, would establish a statutory annual summary from drugmakers on the use of their drugs under the Right to Try Act.
The Right to Try Act, which was passed in 2017, allows patients with life-threatening diseases to access certain unapproved drugs if they've already tried all approved treatment options and are unable to participate in a clinical trial. It is up to drugmakers to decide to provide their drug to a patient under the act.
The proposed rule would implement a statutory requirement for sponsors and drugmakers to provide an annual summary to the FDA for any eligible investigational drug they provide to patients under the Right to Try Act.
The rule is set to be published July 24 and establishes requirements for the deadline and contents of an annual summary.
Read the FDA's full news release here.