Chairman Rick Scott, Ranking Member Gillibrand Send Letter to Major U.S. Pharmacies on Foreign Drug Supply Chain Vulnerabilities

WASHINGTON, D.C. - Yesterday, Chairman Rick Scott and Ranking Member Kirsten Gillibrand of the U.S. Senate Special Committee on Aging sent a letter to the chief executive officers of several of America's largest pharmacies, CVS, Walgreens, and Walmart, requesting information on their efforts to address vulnerabilities in the pharmaceutical supply chain. In the letter, the senators described reports that the Food and Drug Administration (FDA) has granted import exemptions for drugs produced in foreign factories, primarily in China and India, that had previously failed to meet their set safety standards. Chairman Scott and Ranking Member Gillibrand expressed concern that these exemptions, combined with rising geopolitical instability, could threaten drug quality and availability for American patients, particularly seniors. The members also are requesting details on the pharmacies' sourcing of active pharmaceutical ingredients, quality assurance practices, and plans for country-of-origin labeling to improve transparency for consumers and pharmacists.

This letter builds on the chairman and ranking member's previous efforts to strengthen America's drug supply chain, including prior letters to the FDA Commissioner Martin Makary on rare diseases and standards of safety, the Department of Health and Human Services Secretary Robert F. Kennedy, Jr., pharmaceutical distributor executives, and group purchasing organizations, as well as the release of their investigative report exposing the nation's overreliance on foreign-manufactured generic drugs. The committee has also convened two recent hearings, on September 17, examining how dependence on foreign generics threatens drug safety and availability, and on October 8, exploring solutions to bolster domestic manufacturing and ensure Americans' access to safe, high-quality medicines.

Read the full letter HERE or below:

The U.S. Senate Special Committee on Aging is examining how vulnerable pharmaceutical supply chains present a risk to supply chain security. As America's largest pharmacies, CVS, Walgreens, and Walmart play a critical role in ensuring that millions of Americans, including many seniors, have access to safe and affordable generic drugs. Given this essential responsibility, we write to request information regarding CVS's, Walgreens', and Walmart's efforts to address existing supply chain vulnerabilities and ensure your customers understand the source and quality of the medications you dispense.

Recent reporting details how, to prevent and mitigate shortages, the Food and Drug Administration (FDA) has granted exemptions for certain drugs or ingredients subject to import bans that were imposed on foreign factories found to operate under substandard manufacturing conditions. These import bans were a 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 demonstrates an additional threat 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 key manufacturing hubs like 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. 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, disruptions to this supply chain could have profound ramifications for the availability of medications in the U.S., potentially jeopardizing 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 and safe medications.

Given these concerns regarding substandard and potentially unsafe foreign generic drugs entering the U.S. market, country of origin labeling would serve as an important transparency measure for both consumers and pharmacists. Despite a Congressionally-commissioned report from the National Academies of Sciences Engineering and Medicine recommending that the FDA require manufacturing location on drug labels, this information remains inaccessible to both consumers and pharmacists. Research also shows that both pharmacists and consumers exhibit a preference for drugs manufactured in the United States and Canada over foreign drugs from China and India. However, inaccessible and opaque information remains a barrier to allowing buyers and consumers this choice.

Given the critical role pharmacies play as a touch point with Americans who rely on their medications, we request the following information no later than November 30, 2025:

1. As both a number and a percentage, what amount of generic drugs that you dispense prescriptions for each year source APIs from India and/or China?
2. Of the list of drugs that are exempt from the import ban, is your organization currently purchasing any of those drugs from those manufacturers?
   1. If so, what are they, and how many of those drugs have no other manufacturer available?
   2. If so, when did your organization become aware of quality issues with these drugs? Did the FDA notify your organization that these facilities were problematic?
3. Does your pharmacy have any plans to institute country of origin labeling for generic drugs, accessible to pharmacists and customers?
4. As you make decisions on the purchasing of generic drugs, how does your organization account for the resiliency of supply chains as well as the quality of medications?
5. What information does your organization receive with respect to quality assurance when purchasing generic drugs from wholesalers?
6. What information does your organization receive with respect to supply chain resiliency when purchasing generic drugs from wholesalers?
7. To what extent does your organization monitor whether certain generic drugs have been placed under corrective action by the FDA, such as an import ban, Official Action Indicated or Voluntary Action Indicated and how does this inform purchasing decisions?
8. Is your organization aware of the FDA's practice of granting exemptions from import bans, and if so, what steps does it take to avoid purchasing medications that have been exempted?

The health and safety of American citizens, especially our seniors and other vulnerable populations, must be protected from the threats posed by U.S. overreliance on foreign-made generic drugs. Thank you for your continued work to ensure patients have access to affordable medications. We look forward to a continued dialogue on securing the pharmaceutical supply chain for Americans.

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