Securing America’s Drug Supply from Communist China Act

This bill aims to enhance the regulatory oversight of pharmaceutical products by requiring the Secretary of Health and Human Services to review drug applications from Chinese entities. It specifically targets "PRC-, CCP-, or PLA-affiliated entities," defined as those receiving direct or indirect support from the Government of the People's Republic of China, the Chinese Communist Party, or the People's Liberation Army, including entities with specific affiliated individuals on their board or under their control. For new drug applications submitted after enactment, the Secretary must deny approval if the sponsor is determined to be a PRC-, CCP-, or PLA-affiliated entity. Additionally, the bill mandates a retrospective review of drug applications approved since January 1, 2016, to identify existing drugs from such affiliated entities. Drugs identified through this review, when imported or offered for import, shall be refused and destroyed by U.S. Customs and Border Protection without the opportunity for export. To mitigate potential disruptions, the bill establishes a compliance process allowing identified entities to demonstrate non-affiliation or sell their approved application to a non-affiliated entity within 180 days. A critical provision allows for a waiver of import refusal if the Secretary determines it would create or exacerbate a drug shortage in the United States. To support these new regulatory requirements, the bill authorizes an appropriation of $5,000,000 .