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Vivian Xie
9 May 2025

PhRMA trade association issues comments on Section 232 investigation

The Pharmaceutical Research and Manufacturers of America (PhRMA), an American trade association representing groups in the pharmaceutical industry, issued a letter on May 6, 2026 to the Department of Commerce regarding the Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients.

In the letter, the association addresses the current landscape of the US innovative biopharmaceutical sector, and perspectives regarding the US’s global role in research, development, and distribution of innovative medicines. With a strong ecosystem for innovation, PhRMA state in their letter that American patients have earlier and greater access to innovative medicines with a resilient supply chain “overwhelmingly from domestic sources and reliable US allies”. Despite this, the letter expresses concerns regarding trade barriers, specifically stating “We encourage Commerce to focus this investigation on targeted strategic national security concerns, rather than imposing tariffs on innovative medicines that would not advance the Administration’s goal of enhancing national security nor address the trade barriers faced by the industry in foreign markets.”

The 40-page document details how the innovative biopharmaceutical industry is a global leader in US manufacturing, and how the US biopharmaceutical industry is a global leader in medical innovation, before issuing a statement that the US biopharmaceutical industry and its workforce benefit from international trade and investment. “High domestic benefits from global activity and presence, significant foreign direct investment, and major US biopharmaceutical goods exports” are included as evidence of the US’ lead in biopharmaceutical and medical innovation supported by international trade. “Trade with longstanding US allies and security partners allows US patients to access the broadest possible range of treatments and cures, expands access to production inputs for US manufacturers and enhances national security by mitigating the risk of domestic supply disruptions,” the letter states, further stating that the largest source of innovative biopharmaceuticals and ingredients imported to the US are from US allies such as Europe.

Emphasis on maintaining and developing upon the existing supply chain to stay robust and resilient is at the core of the letter. “In developing biopharmaceutical supply chains, manufacturers consider the locations of each source facility and have extensive measures in place to manage the various elements of production processes… It is important to recognize that market dynamics vary for brand or innovative manufacturing companies and generic manufacturing companies… As a result, appropriate attention should be given to increasing resilience concerning critical generic medicines necessary to support acute care during a public health emergency.” The letter further comments on current safeguards to ensure quality of the medicines within the supply chain, and the current geographic diversity of the supply chain itself. “American patients benefit from geographic diversification, especially in the time of pandemics or other emergencies, because it provides companies with flexibility when they need it most.”

The letter ultimately calls for the Section 232 Investigation to focus on specific national security concerns over tariffs on innovative medicines, which they claim will not enhance national security. “PhRMA recognizes that US policymakers have expressed national security concerns regarding the United States’ potential over-reliance on adversarial countries for certain essential medicines. Should the Administration identify and seek to address such dependencies, it should avoid overbroad actions that would inhibit investment in innovative biopharmaceutical manufacturing and research in the United States and unnecessarily burden the US health care system and patients. In particular, the Administration should refrain from imposing tariffs on innovative medicines and inputs, as such tariffs would undermine rather than strengthen national security.”

Source:

PhRMA Comments to U.S. Department of Commerce on 232 Investigation [Accessed May 9, 2025] https://phrma.org/resources/phrma-comments-to-us-department-of-commerce-on-232-investigation

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