What’s in U.S. FDA’s Fiscal 2026 Legislative Request? Key Proposals to Watch

Last month, the U.S. Food and Drug Administration (FDA) released its legislative proposals for fiscal year 2026. These proposals highlight the agency’s most pressing policy concerns and seek new legal tools to address gaps in its regulatory authority. If enacted, the changes would affect drug, device, and biologic manufacturers as well as others engaged in the development, distribution, and oversight of FDA-regulated products.

Understanding FDA’s Legislative Proposals: A Blueprint for Enhanced Authority

Each year, as part of the federal budget process, FDA submits a set of legislative proposals to Congress. These proposals outline the additional legal powers the agency believes it needs — but does not yet have — to carry out its public health mission. These proposals represent FDA’s “wish list” for expanded authority, often reflecting evolving priorities and lessons learned from emerging risks, such as recent supply chain disruptions and data integrity scandals. While Congress may not adopt all of these proposals, key elements often find their way into larger bills or user fee agreements.

By flagging gaps in FDA’s current oversight tools, these proposals signal potential shifts in FDA enforcement and regulatory focus. Understanding them can help organizations anticipate regulatory changes, assess compliance risks, and engage in the legislative process. The 2026 proposals span a range of issues — from import safety and supply chain transparency to data integrity and biosimilar regulation — each reflecting FDA’s push for more robust regulatory authority.

(1) Targeting Unsafe Imported Medical Devices

FDA seeks expanded authority to stop unsafe or noncompliant medical devices from reaching U.S. patients, particularly in cases where problems repeatedly arise from the same foreign sources. The agency notes a continued influx of devices — particularly from China — that pose significant health and safety risks. FDA also indicates potential concerns arising from other jurisdictions, though the proposal does not specifically identify those other countries. The problematic devices include diagnostic tests, surgical masks, and personal protective equipment that fail to meet basic premarket or postmarket standards.

FDA proposes new legal authority to take action when it identifies patterns of violative shipments from particular countries or regions. This new authority would allow FDA to suspend or restrict entry of problematic imports in a more targeted and efficient manner. The agency also seeks broader powers to ensure that foreign device makers comply with FDA’s quality system regulations before exporting products to the U.S. While FDA has not provided detailed specifics on the exact nature and scope of these broader powers, they could include measures such as mandatory pre-export certifications, enhanced documentation requirements, or testing conducted by FDA or third parties to verify compliance.

(2) Requiring Greater Supply Chain Transparency on Drug Labels

To improve supply chain transparency, FDA proposes amending labeling requirements for active pharmaceutical ingredients (APIs), finished drug products, and certain high-risk excipients. FDA wants drug labels and documents to name the original manufacturer of active ingredients and excipients as well as those involved in final production and distribution. Some of this information may be made available electronically, such as through QR codes or online portals, to minimize space constraints on physical labels.

For example, if a hospital receives a sterile product, that hospital would be able to trace from the label the original source of the API as well as determine whether any included excipients originated from a supplier the FDA designated as high risk.

(3) Reporting More Detailed Drug Manufacturing Data

The CARES Act already requires companies registered under Section 510 of the Federal Food, Drug, and Cosmetic Act to report the amount of each listed drug they produce annually. However, this reporting does not capture how dependent manufacturers are on their supply chain partners. FDA believes this gap limits its ability to assess the overall stability of the drug supply chain and respond to emerging shortages.

FDA is now asking Congress to require firms to report the identity of suppliers they used in making each drug and to specify the degree of reliance on each one. For example, if a company sources all of its active ingredient from a single overseas plant, that information would help FDA monitor that vulnerability. The agency also wants a statutory deadline for this reporting to ensure timely and consistent reporting of data.

These enhancements would allow FDA to more efficiently allocate resources, detect early signs of supply chain fragility, and take quicker action when there are disruptions. The goal is to reduce the risk of shortages by making the agency less reactive and more predictive in its oversight.

(4) Cracking Down on Fraudulent Data

FDA is finding more instances of false or unreliable data in product applications and manufacturing records. These issues have surfaced during inspections and remote assessments, sometimes years after a product has entered the market. In some cases, fraudulent data is not detected until a pattern emerges across submissions or facilities, raising broader concerns about systemic integrity.

FDA wants explicit authority to require that all data supporting a product’s application or market status remain available and verifiable for as long as the product is legally sold. This includes data tied to both application-based products and nonapplication products such as over-the-counter drugs under FDA’s monograph system. The agency also seeks additional tools enabling it to invoke enforcement mechanisms more promptly and decisively when it discovers untrue statements of material fact or other signs of data fraud, whether during initial review or after a product has been commercialized, rather than rely solely on postinspection enforcement actions. While FDA has not specified precisely how it would implement this authority, examples of possible actions could include withdrawing product approvals, mandating corrective actions, imposing monetary penalties, or initiating injunction proceedings. These authorities would support enforcement across the entire product lifecycle.

(5) Simplifying the Biosimilar Framework

FDA proposes removing the separate legal category for “interchangeable” biosimilars, proposing that all biosimilars be treated the same for substitution purposes. Under the change, all approved biosimilars would be considered interchangeable. FDA argues that this would reduce confusion and help increase biosimilar use.

The change aligns with scientific consensus and practices in other jurisdictions, such as the EU, and could improve biosimilar uptake. Eliminating the extralegal hurdle for interchangeability could simplify product labeling and lower development costs. This may help accelerate market entry and increase competition, ultimately lowering costs for patients and payers.

(6) Authorizing Destruction of Certain Unsafe Imported Products

Currently, when FDA refuses entry of a product — such as adulterated hand sanitizer or seafood contaminated with carcinogenic veterinary drugs — importers have 90 days to export it. Some importers have exploited this procedure by rerouting or reimporting such products through shell entities or relabeling.

To close this loophole, FDA seeks authority to require destruction of refused products that pose a significant public health risk. The proposal would also allow FDA to require importers to pay destruction costs up front. This would reduce the agency’s reliance on U.S. Customs and Border Protection and streamline the handling of dangerous products at the border.

Stay Tuned — Agriculture Appropriations FY 2026 Bill

Congress has yet to finalize FDA appropriations for FY 2026. On June 27, 2025, the House Appropriations Committee approved its version of the Agriculture-FDA bill (HR 4121), proposing $3.2 billion in discretionary funding — about $300 million below FY 2025 levels — while fully supporting $3.6 billion in user fees.

The Senate has not finalized its bill but has released a draft signaling support for higher FDA funding, including targeted increases for cosmetics oversight, medical product safety, and global inspections. Negotiations are expected to continue into the fall, with final appropriations likely tied to broader budget talks.

Stakeholders should monitor both the progress of these funding bills and any companion authorizing measures in the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor, and Pensions, which will determine whether the agency’s legislative priorities advance this fiscal year.