This bill requires the Food and Drug Administration to review pharmaceutical products from Chinese entities to determine if they are affiliated with the Chinese government, the Communist Party, or the People's Liberation Army. Drug applications submitted after the bill's enactment by such affiliated entities would be automatically denied approval, while applications submitted between January 2016 and enactment would be reviewed retroactively. Any drugs already approved by these affiliated entities would be refused entry at U.S. borders and destroyed, though the Commissioner of Customs and Border Protection could grant a waiver if the denial would cause a drug shortage. Affected companies would have 180 days to sell their approved applications to non-affiliated entities or demonstrate they are no longer government-affiliated. The bill authorizes $5 million in spending to implement these regulatory reviews and enforcement measures.
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