Senate bill proposes study of the US pharma supply chain

By Jenni Spinner contact

- Last updated on GMT

(Images: US Senate; Michael Vadon)
(Images: US Senate; Michael Vadon)

Related tags: Regulation, Supply chain, API, Active ingredient, Excipients

The bipartisan bill calls for an assessment of the country’s pharma supply chain, including potential vulnerabilities and impact of foreign manufacturing.

Sen. Elizabeth Warren (D-Massachusetts) and Sen Marco Rubio (R-Florida) joined together and cosponsored S. 4191, the United States Pharmaceutical Supply Chain Review Act. The bill directs various agencies and offices to analyze various aspects of the country’s pharmaceutical supply chain.

In their jointly released one-page summary of the legislation, the Senators cited concerns about the country’s growing reliance on overseas sources for the supply of pharmaceutical products the country’s citizens depend upon.

Today, nearly 80% of the active pharmaceutical ingredients (APIs), the requisite component of drugs used in generic drugs, are imported from abroad. This overreliance leaves our supply chain of critical drugs used by millions of Americans vulnerable to disruption – whether by accident or by design​,” the statement reads.

This overreliance stems, in part, from foreign investment in the US pharmaceutical supply chain​,” the text continues. “While not all foreign investment is problematic, experts have warned that significant foreign control of US-based pharmaceutical companies could stymie domestic capacity and exacerbate the nation’s overreliance on foreign nations for its APIs, raw ingredients, and finished drugs. Despite the risks posed to the United States, the nation lacks detailed information on the nature of this investment​.”

According to the text of the legislation, the bill would direct the Federal Trade Commission (FTC) and Secretary of the Treasury, acting through the Committee on Foreign Investment in the United States (CFIUS), to have submitted assessments of the following within one year of enactment:

  • The country’s supply chain, and the impact therein on concentration and reliance on foreign manufacturing in the pharma industry
  • Ways in which foreign investment impacts the US’s capacity to produce drugs, active pharmaceutical ingredients (APIs) and excipients
  • Whether foreign investment in US on technologies and products for sequencing and storing DN impacts the capacity to sequence or store DNA in the country.

The bill was introduced into record by Sen. Warren and referred to the Senate Committee on Banking, Housing and Urban Affairs. The senators are working to gather additional sponsors for the piece of legislation before moving forward; neither could be reached for additional comment. 

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