Helping Experts Accelerate Rare Treatments Act of 2022
This bill requires studies on processes for approving drugs that treat rare diseases and conditions.
The Government Accountability Office (GAO) must contract with an appropriate entity to study the European Union's process for evaluating the safety and efficacy of such drugs, including any flexibilities or mechanisms that are specific to rare diseases or conditions. The GAO must also conduct a study about the Food and Drug Administration's mechanisms for ensuring that patient and physician perspectives are considered when evaluating and approving drugs for rare diseases or conditions.
The GAO must report to Congress the results of these studies.