Chairman Rick Scott, Ranking Member Kirsten Gillibrand Send Letter to Pharmaceutical Distributor Executives on Regulatory Oversight of Foreign-Manufactured Generic Drugs

WASHINGTON, D.C. - Today, Chairman Rick Scott and Ranking Member Kirsten Gillibrand of the U.S. Senate Special Committee on Aging sent a letter to pharmaceutical distributor executives requesting information on vulnerabilities in the U.S. pharmaceutical supply chain. This letter is part of the committee's work to investigate how American overdependence on foreign generic drug manufacturing and weaknesses in regulatory oversight can pose a threat to public health and national security. The chairman and ranking member are requesting insight from pharmaceutical distributors on how disruptions in the supply of active pharmaceutical ingredients, key starting materials, and generic drugs, including those from China and India, could impact access to safe and effective medications for American patients, particularly the aging community.

This letter to pharmaceutical distributor executives follows a letter from Chairman Scott and Ranking Member Gillibrand to group purchasing organization executives this week, and the release of their investigative report, which exposes America's harmful overreliance on foreign-manufactured generic drugs. On September 17, the Aging Committee held a hearing highlighting how U.S. overreliance on foreign generic drugs can threaten drug safety and availability, and in a second hearing on October 8, the members and expert witnesses discussed potential solutions to strengthen domestic pharmaceutical supply chains and ensure access to safe, high-quality medicines for every American.

Read the letters HERE or below:

The U.S. Senate Special Committee on Aging is examining how vulnerable pharmaceutical supply chains present a risk to public health and national security. As pharmaceutical distributors, McKesson, Cardinal Health, and Cencora hold a vital position in the secure storage and efficient delivery of pharmaceutical products to health care providers and patients. This unique role in the supply chain equips McKesson, Cardinal Health, and Cencora with enhanced visibility into the availability and distribution of generic drugs, which is especially important in maintaining consistent access to safe and effective essential medications. Given this critical responsibility, we write to request information and insight regarding existing supply chain vulnerabilities.

Recent reporting details how, in order to prevent and mitigate shortages, the Food and Drug Administration (FDA) has granted exemptions for certain drugs or ingredients subject to import bans imposed on foreign factories found to operate under substandard manufacturing conditions. These import bans were the result of a failure to comply with FDA standards and exempting these drugs or facilities allows for substandard and potentially unsafe drugs to enter the U.S. market. These reports highlight that many of these exemptions are for factories in China and India and identify more than 150 drugs and ingredients that have received exemptions since 2013. While many factories ultimately make the necessary changes to be removed from the FDA's import alert list, these exemptions can pose a threat to drug safety for American consumers.

Moreover, recent instability in geopolitics and global trade demonstrate additional threats to the stability of our pharmaceutical supply chain, particularly the supply of key starting materials (KSMs), active pharmaceutical ingredients (APIs) and generic drugs imported from manufacturing hubs such as China and India. A recent trade dispute with China exemplifies this dynamic despite reaching a bilateral trade agreement on rare earth elements in April 2025, China imposed a new set of export restrictions on October 9, demonstrating its willingness to use trade commodities as leverage against the U.S.3 This raises the unsettling possibility that China could similarly restrict exports of pharmaceutical products in future diplomatic or trade conflicts. Given that China is one of the world's largest suppliers of APIs and KSMs, any disruptions in this supply chain could have profound ramifications for the availability of medications in the U.S. and potentially jeopardize patient care and public health.

Ultimately, the interaction between regulatory oversight and geopolitical dynamics presents significant challenges to the safety and reliability of our pharmaceutical supply chain. It necessitates ongoing vigilance and proactive measures to ensure that patients receive high-quality, safe medications.

Distributors' work with hospitals and pharmacies provides them with valuable insight into the supply chain for generic drugs. Based on this unique purview, we request the following information by November 30, 2025:

1. Of the list of drugs that are exempt from the import ban, is your company currently storing or delivering any of those drugs from those manufacturers?
2. 1. a. How many of those drugs have no alternative manufacturer available?
3. When did you become aware of potential quality issues with these drugs?
4. 1. Did the FDA notify you that these facilities were problematic?
   1. If so, when?

1. If China were to stop exports of generic drugs, APIs, or KSMs to America or to Indian companies that sell to the U.S., how many days of drug inventory do you estimate that the U.S. has of various generic drugs before it would run out?
2. What tools does your company have to detect whether a drug is at risk of a shortage?
3. How has your company's ability to detect supply chain vulnerabilities improved since 2010?

As chairman and ranking member of the U.S. Senate Special Committee on Aging, the health and safety of Americans, especially our seniors, is our top priority. Thank you for the work that McKesson, Cardinal Health, and Cencora do every day to secure supply chains for generic medications and help patients access the treatment they need. Thank you for your attention to this matter. We look forward to your response.

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