Study Of The Expedited Programs In The American New Drug Approval

In order to achieve the goal of completing the review of drugs on time and solve the delay in the review of new drug marketing approval,China has been constructing China's the Expedited Programs of in the past two years with reference to the America.Under the current background of the reform of the pharmaceutical and health system,it can be foreseen that the Expedited Programs will become an important part of the new drug approval system in our nation and will be used a lot.According to the experience around the world,compared with the standard review procedure,the Expedited Programs not only has obvious institutional superiority,but also has the drawbacks that can cause serious threats and great harm to public health.Therefore,how to effectively control the application of the Expedited Programs from the perspective of administrative law and prevent it from being abused by drug regulatory agencies under the influence of politics or commerce is an issue that we must face and think about in building this process.Since the establishment of the Expedited Programs in 1992,the United States has formed a relatively complete system of expedited programs.This system has made great contributions to the development of the American pharmaceutical industry and the protection of public health benefits,and has become a model for the construction of drug approval systems worldwide.However,in practice,the expedited programs have also been criticized as having been abused to please commercial interest groups,resulting in a series of drug safety incidents.China's drug regulatory authority is currently referring to the America's efforts to build a system of the Expedited Programs.Problems in the America may also occur in China in the future.In the future,how to prevent the abuse of the expedited programs has become a question worthy of thinking in administrative law.Currently,the expedited programs of the America includes four specific pathways,include,in 1992 to establish "priority review",established in 1997,"fast-track",established in 2012 "breakthrough therapy" and was established in 1992 but until "accelerated approval" in 2012 was only legally recognized.Each of the four procedures has its own legal basis,applicable conditions,content characteristics,and start-up procedures,and is mutually independent and revocable.From an administrative law point of view,the Expedited Programs are an administrative summary procedure.There is no concept of "administrative summary procedure" in American administrative law,which is based on the theory of administrative law in our country.The features of the Expedited Programs are in line with the general characteristics of the administrative summary procedure,ie,they appear in the form of less administrative time,more convenient administrative measures and,in essence,more pursuit of administrative efficiency.At the same time,it is also an administrative investigation procedure to place the Expedited Programs in the process of administrative approval review.There are many ways to investigate a program,but in essence it is a process of gathering information and finding out the facts.In terms of content,the Expedited Programs are a process of collecting information about medicines and identifying the safety and effectiveness of medicines,in full compliance with the essential characteristics of an administrative investigation process.The establishment and development of the Expedited Programs are the result of the promotion of three interest groups.One is the public health interests represented by the FDA,the second is the commercial interests represented by pharmaceutical companies,and the third is the health benefits of serious illness patients as minority groups.At the same time,the effectiveness of the system of the Expedited Programsitself has also provided sufficient legitimacy for the continued development of the system.However,there have been many criticisms of the rapid review process.These criticisms mainly believe that the rapid review process has lowered the standards for review of new drug listings and that the abuse of procedures has caused problems with the safety and efficacy of new drugs.As an administrative procedure that has space for choice in its application,the expedited programs may also be arbitrary in the application process,and it is therefore necessary to be controlled by the law.There are mainly three types of control over administrative discretion: parliamentary legislation,administrative legislation and judicial review.The law provides more detailed provisions on the applicable conditions,specific measures and revocation procedures for the four kinds of the expedited programs.These laws that make these provisions are mainly the “Federal Food,Drug and Cosmetic Act”,“Prescription Drug Users Fee Act”,“Food and Drug Administration Modernization Act” and “Food and Drug Administration Safety and Innovation Act”.In order to better apply the expedited programs,FDA has also formulated corresponding administrative rules to further clarify the legal provisions that constitute self-restraint for the FDA's applicable the expedited programs.As one of the most important forces to constrain the administrative act,the Federal Supreme Court brought the administrative discretion into the scope of judicial review through the principle of presumption of presumption,which effectively controls the discretion of the FDA in choosing the applicable procedure.However,due to the limitation of judicial review by the Chevron Principle,the degree of judicial review has weakened the control of procedural discretion that depends on administrative interpretation.From the perspective of administrative discretion,the application of the expedited programs is actually the result of the FDA exercising the discretion of the procedure.Therefore,the basic requirements for the application of discretionary power in administrative law should be complied with.Administrative rule of law on the administrative discretion of the basic requirements of both legitimacy and rationality,legality requires that the discretion should meet the legal requirements of the facts and procedures,the rationality of the request that the discretion should betreated equally relative people.However,due to the extremely complicated identification of drug safety and efficacy,limited FDA information and the limitations of expert opinions cannot make FDA clear and accurate in identifying facts,which has challenged the validity of the procedure.On the other hand,when facts are found to be difficult,the FDA will choose to explain through the concept to avoid the application of the procedure does not meet the statutory conditions.However,because there is no precedent system,FDA's interpretation may be different each time,which provides ample room for abuse.Although in theory Congress can use explicit legislation to resolve the issue of the abuse of discretion,the parliament actually cannot afford to do so and has to give the FDA broad authority.At the same time,due to the limitations of the Chevron Principle and the lack of its own administrative experience,the courts can only respect the FDA in the face of the highly professional concept of drug regulation.Therefore,it seems that there are three-pronged constraints,but in fact it is difficult to make the application of the rapid review process meet the requirements of administrative rule of law.Difficult to solve the dilemma is that unless the FDA itself strictly in accordance with the law,otherwise the parliament and the court almost cannot pass the legislative and judicial review to bind the FDA abuse of discretion.