U.S. Senators Marco Rubio (R-FL) and Elizabeth Warren (D-MA) recently announced plans to cosponsor S. 4191, the United States Pharmaceutical Supply Chain Review Act. According to bill text released by Senator Warren’s office, the bill directs the Federal Trade Commission (FTC) and the Secretary of the Treasury, in consultation with the Secretary of the Treasury, and acting through the Committee on Foreign Investment in the United States, to study the U.S. pharmaceutical supply chain. Specifically, within one year of enactment, the agencies identified would be required to study and submit an assessment of:
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- The U.S. pharmaceutical supply chain “and the effect of concentration and reliance on foreign manufacturing within that industry,”
- The U.S. pharmaceutical supply chain “and the effect of concentration and reliance on foreign manufacturing within that industry,”
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- How foreign investment impacts U.S. “domestic capacity to produce drugs and active and inactive ingredients of drugs,”
- How foreign investment impacts U.S. “domestic capacity to produce drugs and active and inactive ingredients of drugs,”
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- Whether foreign investment in U.S. genome sequencing technology affects “the capacity to sequence or store DNA in the United States,” and
- Whether foreign investment in U.S. genome sequencing technology affects “the capacity to sequence or store DNA in the United States,” and
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- An accounting of CFIUS reviews over the past ten years of foreign investment in the pharmaceutical and genome sequencing industries.
- An accounting of CFIUS reviews over the past ten years of foreign investment in the pharmaceutical and genome sequencing industries.
The bill was introduced by Senator Warren and referred to the Senate Committee on Banking, Housing, and Urban Affairs. It appears the senators are still working to gather cosponsors for the bill.
Senators Rubio and Warren also released a one-page summary of the bill. The summary cites a 2019 annual report conducted by the U.S.-China Economic Security Review Commission that found nearly 80 percent of active pharmaceutical ingredients (APIs) are imported from abroad. The Senators conclude that an “overreliance [on APIs] leaves our supply chain of critical drugs used by millions of Americans vulnerable to disruption – whether by accident or by design.”