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S. 1366: Pharmaceutical Supply Chain Defense and Enhancement Act


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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on Apr 26, 2021.


Pharmaceutical Supply Chain Defense and Enhancement Act

This bill requires the Department of Health and Human Services (HHS) to enter into contracts with U.S. entities to manufacture certain critical drugs within the United States.

The Food and Drug Administration (FDA) must periodically report to Congress a list of drugs that are critical to public health or national security. The Biomedical Advanced Research and Development Authority within HHS must enter into contracts for qualified U.S. entities to manufacture in the United States the drugs on this list (and ingredients for such drugs). Such contracts must impose certain conditions, such as requiring the manufacturing entity to (1) develop and maintain a redundancy risk management and continuity of business plan, and (2) commit to selling the drugs and ingredients manufactured under the contract at reasonable prices.

Beginning in FY2025, certain federal agencies, including the Department of Defense and the Bureau of Prisons, must give priority, in procuring drugs on the FDA critical drugs list, to those that are manufactured in the United States and of high quality.

The bill also requires the Federal Trade Commission to submit annually to Congress a report on foreign investment in the U.S. pharmaceutical industry. The report must address, among other topics, the effect of the industry's reliance on foreign manufacturing.