Senate Aging Committee leaders seek answers from HHS on foreign drug supply chain risks

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Rick Scott, Chairman of the Senate Special Committee on Aging | Official photo

Senate Aging Committee leaders seek answers from HHS on foreign drug supply chain risks

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Chairman Rick Scott and Ranking Member Kirsten Gillibrand of the U.S. Senate Special Committee on Aging have sent a letter to Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., raising concerns about the United States’ dependence on foreign-manufactured generic drugs, particularly those from China and India. The senators requested detailed information from HHS regarding its efforts to strengthen the resilience of pharmaceutical supply chains and reduce risks related to drug shortages.

The letter follows an investigative report by Scott and Gillibrand that examined the country’s reliance on foreign-made generic drugs. The committee has also held hearings in September and October 2025 to discuss threats posed by this overdependence, as well as possible solutions for improving domestic pharmaceutical manufacturing.

In their letter, the senators noted that “the United States extensively relies on the import of key starting materials (KSM), active pharmaceutical ingredients (API), and finished dosage form (FDF) generic drug products.” They pointed out that about 91 percent of prescriptions in the U.S. are filled with generic drugs each year, highlighting the importance of securing these supply chains for all Americans, especially seniors.

Scott and Gillibrand expressed concern about limited oversight over foreign manufacturing, which they said represents a vulnerability in the event of a crisis. They cited recent reports indicating that since 2013, more than 150 drugs or ingredients from factories—many in China and India—have received exemptions from import bans despite substandard conditions. While some facilities later comply with standards, such exemptions can pose risks to drug safety.

The senators also referenced geopolitical tensions as a potential threat to pharmaceutical supply stability. They discussed a recent trade dispute with China involving rare earth elements as an example of how essential exports could be restricted during diplomatic conflicts, raising concerns that similar actions could affect pharmaceuticals.

Another issue highlighted was that approximately 40 percent of generic medications are produced by only one FDA-approved manufacturer, making these drugs more susceptible to shortages if disruptions occur.

To address these challenges, the letter called for updates on several initiatives managed by HHS and its subagencies. These include progress on the Strategic National Stockpile (SNS), development of the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), and implementation of Executive Order 14336 issued in August 2025, which aims to stockpile critical APIs.

The senators asked HHS for a briefing on SNS and SAPIR capacities, inventories of medicines held in reserve, cost estimates for maintaining reserves, protocols for releasing APIs during shortages, strategies for replenishing stockpiles nearing expiration, coordination among agencies in responding to shortages, staffing plans for overseeing responses, incentives for domestic manufacturers to secure inputs locally, assessments of medicines at risk if imports from China or India are disrupted, readiness plans for national emergencies affecting supplies, and details about planned enhancements to SNS capabilities.

“As chairman and ranking member of the Senate Special Committee on Aging, the health and safety of Americans, especially our seniors, is our top priority,” wrote Scott and Gillibrand. “We must work to address existing supply chain vulnerabilities, including our nation’s extreme reliance on foreign generic drugs. Inaction to address these supply chain concerns could be catastrophic. We stand ready to support HHS in bolstering the nation’s public health preparedness and national security.”

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