FDA proposes new rule on reporting requirements under Right to Try Act

The US Food and Drug Administration on Thursday published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA for any eligible investigational drug they provide to eligible patients under the Right to Try Act.

The proposed rule would have manufacturers and sponsors of eligible investigational drugs submit an annual summary of any use of the drug as supplied under section 561B of the Federal Food, Drug, and Cosmetic (FD&C) Act. The federal statute requires that annual summary reporting include the uses for which the drugs were supplied, the number of doses supplied, how many patients were treated, and any known serious adverse events occurring from use of the investigational drug.

"The FDA is dedicated to achieving the goals that Congress set forth in the Right to Try Act, so that patients facing terminal conditions have another avenue to access investigational medicines," said Dr Anand Shah, Deputy Commissioner for Medical and Scientific Affairs, adding: "Today's proposed rule builds on the FDA's long-standing dedication to enhancing access for patients who are facing life-threatening diseases or conditions and our continued commitment to transparency."