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May 07, 2021

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Senators Announce Bipartisan Bill Requiring Pharmaceutical Supply Chain Report

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:

  • The U.S. pharmaceutical supply chain “and the effect of concentration and reliance on foreign manufacturing within that industry,”

  • How foreign investment impacts U.S. “domestic capacity to produce drugs and active and inactive ingredients of drugs,”

  • Whether foreign investment in U.S. genome sequencing technology affects “the capacity to sequence or store DNA in the United States,” and

  • 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.”

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© Copyright 2021 Squire Patton Boggs (US) LLPNational Law Review, Volume X, Number 203
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About this Author

John E. Wyand, Squire Patton Boggs, Healthcare Lawyer, UK
Partner

John Wyand, a Partner in our Healthcare policy practice group in Washington DC, focuses on advising healthcare and life sciences companies and providers on legal, policy and regulatory issues. Additionally, he regularly assists hospitals and physician groups in developing strategies for hospital/physician alignment, mergers and acquisitions, and fraud and abuse compliance.

202 626 6676
Callan J. Smith Public Policy Healthcare Squire Patton Boggs Washington, DC
Associate

Callan Smith is a member of the Public Policy Healthcare Practice, where he provides strategic counsel to clients navigating federal legislative and regulatory issues, drawing from his background working on healthcare issues in Washington DC over the last 10 years, first on Capitol Hill and then for a governor’s federal affairs office.


Callan developed his understanding of Congress as a legislative staffer on the US Senate Committee on Finance, working for Chairman Max Baucus (D-MT). He prepared briefing materials and memoranda for the Chairman on a range of policy topics,...

202-457-6097
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