Research On The Accelerated Approval In The United States

This paper reviews the history of Accelerated Approval,institutional structure,administrative discretion and subsequent regulation,and then reflects on the construction of Chinese drug conditional approval system,and surveys the nature of the conditional approval system from the perspective of administrative licensing at last.The U.S.drug regulation has undergone several reforms,gradually clarifying the safety and efficacy of listed drugs.FDA was caught in a delay in approving drugs without differentiating the severity of the disease and applying a uniform approval standard and proceedings to all drugs.The AIDS crisis in the 1980 s gave rise to the Accelerated Approval system.The institutional structure of the Accelerated Approval includes the scope of application,the applicable procedures,and additional conditions.Patients with serious diseases usually accept a higher risk of drug use than the average patient.The sponsor should meet with the FDA as early as possible to demonstrate the safety of the drug and that the proposed surrogate endpoint can reasonably predict clinical benefit.FDA may impose three additional conditions,including post-marketing confirmatory trials,early submission of marketing materials,and restrictions on distribution and use of the drug.Aduhelm,a new drug for Alzheimer’s disease,is one example of administrative discretion of Accelerated Approval.The regulatory authority takes not only the clinical trial data submitted by the sponsor into account,but also the size of the patient population,severity of the disease,trends in drug development,and congressional policy on new drug development.The uncertainty inherent in the drug regulatory process preserves a pipeline for political and policy factors to influence approval decisions.Subsequent regulation of Accelerated Approval is divided into three main areas:regulation of confirmatory trials,drug labeling management and expedited revocation procedures.If a pharmaceutical company fails to perform confirmatory trials as required,FDA will issue a warning letter or impose a fine.Drug labeling is divided into three areas:the formulation of indications under the Accelerated Approval,labeling changes after clinical benefit has been confirmed,and labeling changes when an indication is withdrawn but other indications are valid.Revocation of Accelerated Approval is an informal adjudicative act that requires an informal hearing,although the FDA rarely applies the revocation process on its own initiative.Chinese Conditional Approval system is largely the result of top-down policy driven by the State Council.In the future,drug regulatory authorities may be encouraged to apply the Conditional Approval flexibly,implement categorical regulation for different types of post-marketing studies,and construct a special revocation process.Perhaps the Conditional Approval system can be not only seen as a conditional administrative act,or an simplification of administrative license,but also as a risk regulation tool.