The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a hearing on June 11, 2025, titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing assessed America's reliance on foreign sources for drugs and active pharmaceutical ingredients (APIs), the need to stabilize and grow domestic drug manufacturing capabilities, and the overall fragility of the U.S. drug supply chain.
The hearing addressed challenges for nearly every actor in the drug supply chain, including brand drug, generic drug and API manufacturers, group purchasing organizations (GPOs) and pharmacy benefit managers (PBMs).
Hearing Overview
The Health Subcommittee members were in agreement that America's drug supply chain is broken and must be bolstered to protect and enhance American access to finished drug products and APIs. Members were clear that the U.S. drug supply chain was broken long before the COVID-19 pandemic, which exacerbated existing vulnerabilities and weaknesses in the supply chain. Geographic concentration of API manufacturing in China, India and Europe, as well as misaligned incentives, high regulatory burdens and weak oversight measures by U.S. agencies and foreign entities, have all contributed to a fragile supply chain.
Although there was bipartisan agreement that more can be done to ensure that the U.S. has the resources needed to maintain a consistent supply of safe, effective medicines, members offered an array of potential solutions, including:
- eliminating regulatory barriers, such as streamlining certain permitting processes for new API and key starting materials (KSMs) facilities
- streamlining U.S. Food and Drug Administration (FDA) review processes to speed the approval of new generic drugs and introduce competition to branded drugs
- providing sustained federal support through multiyear contracts and introducing permanency for tax incentives to spur domestic production
- initiating public-private partnerships to facilitate production of generic medicines at high risk of disruption
- requiring transparent labeling for API sourced overseas to enhance transparency
Democratic members highlighted the chasms between the Trump Administration's policy goals in the drug policy space and the capacity of relevant federal agencies to execute those goals, given reductions in force (RIFs) across the U.S. Department of Health and Human Services (HHS), recissions of existing regulations, and reduced funding for federal healthcare agencies involved in supporting the preparedness and strength of the overall healthcare system.
What's Next?
Members of Congress remain far apart on agreeing to a comprehensive, bipartisan solution to address drug shortages and strengthen the drug supply chain. At this time, it appears unlikely Congress will act on legislation that implements broader reforms without a major galvanizing event – such as a natural disaster that results impacts a single manufacturing facility or quality issues with a sole-source drug.
In addition, with Congress' short term focus centered upon passing a reconciliation package to extend tax cuts from the Tax Cuts and Jobs Act and reduce federal spending on healthcare programs such as Medicaid, the Trump Administration is expected to continue advancing policy priorities through regulatory changes and other administrative means. These changes are likely to impact not only the drug supply chain but also the pharmaceutical sector more broadly.
Given existing and long-standing vulnerabilities in the supply chain and the likelihood for action by the Trump Administration on drug policy issues, the coming months will offer significant opportunities for stakeholder engagement through the rulemaking, legislative, appropriations and legal processes. Although implementation and enforcement of administrative actions may provide the most upfront risk to drug manufacturers, suppliers, distributors and healthcare facilities, stakeholders may also have significant opportunity to engage with the Trump Administration and Congress on the following major topics:
- initiatives related to Executive Order (EO) 14297, titled "Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients," at the agency, congressional and executive levels through open comment periods, public meetings and legislative activity before committees of jurisdiction in the U.S. House and Senate
- sector-wide tariffs on pharmaceutical products, pursuant to findings from a Section 232 investigation into the national security risks related to importing pharmaceutical products, led by the U.S. Department of Commerce, which may offer stakeholders an opportunity to engage with a range of department leaders
- heightened enforcement of foreign manufacturing facilities and reduced inspection capacity domestically
- ongoing administrative efforts to reduce overall regulatory requirements for companies across the healthcare sector by rescinding or revising agency actions, which will involve notice-and-comment rulemaking and may lead to additional requests for information
Given the heightened awareness of the issues facing the drug industry and the larger healthcare sector, there could also be a number of enforcement and judicial actions that may further exacerbate supply chain issues while a legislative fix unfolds. Specifically, to address the potential harm to members of the public caused by a restriction of the current availability of medicines:
- Members of Congress and committees with jurisdiction over healthcare issues could seek documents and testimony from companies to better understand issues at hand.
- Government agencies may issue Civil Investigative Demands to compel further information to determine if there are potential violations of federal law, which could include antitrust or false claims violations.
- State attorneys general may pursue investigations to see if there are potential violations of state law, including consumer protection violations.
- Plaintiffs' law firms and advocacy groups may initiate legal proceedings (including nationwide class actions) to challenge whether any restrictions are causing an improper restriction of available medical options.
