This final rule establishes the deadline for submission of annual summaries of use of investigational drugs supplied under the Right to Try Act. The rule also establishes the required contents of these submissions. These reporting requirements instruct firms to collect all known serious adverse events and submit them once per year to FDA. In addition, based on the information in these annual summaries, FDA intends to post online an annual summary report in accordance with section 561B(d)(2) of the FD&C Act.

The benefits of this rule consist of societal and public health outcomes that may accrue from the disclosure of the use of investigational drugs and any known serious adverse events provided in these annual summary reports. There is no data that would allow us to predict the magnitude of generated benefits and thus we are unable to quantify the expected benefits of this rule.

Costs are estimated as the time spent by firms to prepare and submit these annual summary reports. The total estimated present value of this rule’s costs is $37,132 at a seven percent discount rate and $45,818 at a three percent discount rate. The annualized cost of this rule over 10 years is $5,287 at a seven percent discount rate and $5,371 at a three percent discount rate.

Regulatory Impact Analysis

Annual Summary Reporting Requirements Under the Right to Try Act Final Regulatory Impact Analysis (PDF)

Federal Register: 87 FR 56269, September 14, 2022

Docket: FDA-2019-N-5553