“A bill to require regulatory review of pharmaceutical products from Chinese entities, and for other purposes.”
No CRS summary available for this bill.
This section establishes definitions for a "Chinese entity," "drug application" (i.e., new drug applications, abbreviated new drug applications, or biologics license applications), "PRC-, CCP-, or PLA-affiliated entity" (i.e., entities receiving support from, owned or controlled by, or with specified officials or executives of the People's Republic of China government, Chinese Communist Party, or People's Liberation Army), and "Secretary" (i.e., HHS Secretary acting through FDA Commissioner). The section requires the Secretary, in coordination with HHS's Office of National Security, to review each drug application submitted on or after enactment by a sponsor that is a Chinese entity or licensing a product owned by one—including any referenced Drug Master File—to determine if the sponsor is a PRC-, CCP-, or PLA-affiliated entity, and to deny approval of any such application if so determined. The section further requires the same review process for drug applications submitted from January 1, 2016, through the day before enactment, covering both sponsors and approved application holders. The section amends FFDCA §801 to require FDA to provide CBP with a list of drugs whose sponsors or approved application holders are determined under the prior review to be PRC-, CCP-, or PLA-affiliated entities; directs CBP to refuse and destroy such imported drugs (without export opportunity); and establishes (1) a process allowing sponsors or holders to demonstrate they are no longer affiliated or to sell the application within 180 days to a non-affiliated entity (with a hearing opportunity), after which FDA notifies CBP if satisfied, and (2) a CBP waiver authority for imports if FDA determines refusal would create or exacerbate a U.S. drug shortage. The section authorizes $5 million to carry out these requirements and amendments, to remain available until expended.