Affordable and Safe Prescription Drug Importation Act of 2025

Bill Number

H.R. 3162

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-05-01: Referred to the House Committee on Energy and Commerce.

Last Updated

2026-04-03T18:55:14Z

AI-Generated Summary

Purpose

The Affordable and Safe Prescription Drug Importation Act of 2025 aims to lower high prescription drug prices in the United States by amending the Federal Food, Drug, and Cosmetic Act (FFDCA) to permit the safe importation of qualifying drugs from certain foreign countries. It addresses the crisis of unaffordable drugs by allowing wholesale distributors, pharmacies, and individuals to import drugs that are cheaper abroad but meet U.S. safety standards, while ensuring oversight by the Food and Drug Administration (FDA).

Key Provisions

• Findings and Sense of Congress: Recognizes that U.S. drug prices are significantly higher than in other OECD countries (e.g., 2.78 times higher on average), leading millions of Americans to skip prescriptions due to cost. It notes the safety of foreign drug manufacturing (via FDA mutual recognition agreements with the UK, EU, and Switzerland) and the existing reliance on imported drugs. Congress expresses that current bans on importation have artificially inflated prices and that safe global sourcing is feasible with proper FDA oversight.

• Importation Regulations: The FDA Secretary must issue rules within one year of enactment to allow importation of "qualifying prescription drugs" from Canada, the UK, EU member states, and Switzerland (with potential expansion to other countries after safety reviews). Qualifying drugs must have the same active ingredients, administration route, and strength as FDA-approved versions (or be biosimilar for biologics) and meet labeling requirements, including English labels.

• Certified Foreign Sellers: Foreign pharmacies or wholesalers in approved countries can be certified by the FDA if they meet criteria like compliance with local laws, quality assurance programs, recall notifications, and grievance processes. Certified sellers pay an annual fee to cover FDA administration costs and must be listed on an FDA website. Certifications last two years, with recertification available.

• Importer and Individual Access:
• Importers (U.S. pharmacies or wholesalers): Can import qualifying drugs, including insulin, peritoneal dialysis solutions, certain biologics (e.g., proteins), drugs with risk evaluation and mitigation strategies (REMS, which are FDA plans to ensure safe use), and IV-infused drugs.
• Individuals: Can import up to a 90-day supply for personal use (not resale) from certified foreign pharmacies, but only with a valid U.S. prescription from a practitioner after an in-person exam. Excludes controlled substances, surgical anesthetics, and compounded drugs.

• Expansion to Other Countries: After one year, if imports from initial countries prove safe (based on reports), the FDA can approve additional countries with rigorous drug approval, manufacturing, and safety reporting standards.

• Safety and Enforcement Measures:
• FDA can approve labs for random testing of imported drugs for authenticity.
• Importers must submit biannual reports on drug sources, transactions, and prices.
• Immediate suspension of imports for patterns of counterfeits, recalls, or violations; temporary suspensions for potential risks.
• Supply chain rules require purchases from registered manufacturers or certified sellers, with tracing information provided.
• Imported drugs meeting labeling rules are not considered "misbranded" (i.e., falsely labeled under FFDCA).
• For drugs under REMS, importers must follow those safety protocols.

• Manufacturer Restrictions: Prohibits drug makers from discriminating against certified sellers (e.g., charging higher prices, delaying supplies, or altering drug formulations to block imports), except during shortages. Violations can lead to enforcement actions.

• Enforcement Discretion for Individuals: FDA should prioritize enforcement against risky imports and allow personal imports that pose no significant health threat. The Secretary can grant waivers for specific cases and issue guidance on when waivers apply.

• Penalties and Reporting: Adds up to 10 years imprisonment and $250,000 fines for online sellers defrauding U.S. buyers with adulterated/counterfeit drugs or dispensing without valid prescriptions. Requires HHS biennial reports on imports and a GAO report 18 months after regulations on implementation, safety, and cost savings. Does not preempt state or federal laws providing civil remedies.

Significant Changes to Existing Law

• Replaces Section 804 of the FFDCA: Overhauls the prior narrow, state-sponsored importation program (limited to Canada via wholesalers) to broadly allow imports by U.S. dispensers, wholesalers, and individuals from multiple countries, including biologics and specific high-need drugs like insulin.
• Expands Personal Importation: Current law technically bans most personal imports (with FDA enforcement discretion), but this act legalizes them under strict conditions, reducing seizure risks.
• Anti-Discrimination Rules: Introduces new prohibitions on manufacturers interfering with imports, which were not explicitly addressed before.
• Certification and Oversight: Establishes a formal FDA certification process for foreign sellers, fees, testing, and reporting—replacing ad-hoc waivers with structured regulations.
• Online Penalties: Adds specific criminal penalties under FFDCA Section 303 for fraudulent internet drug sales to U.S. individuals.

Potential Impacts

• On Citizens: Could reduce out-of-pocket drug costs by enabling access to lower-priced versions from abroad, potentially benefiting tens of millions who skip medications due to price. Individuals gain clearer legal pathways for personal imports, improving health access without financial ruin.
• On Government Agencies: FDA and HHS face increased responsibilities for regulations, certifications, testing, reporting, and enforcement within tight timelines (e.g., one year for rules), potentially straining resources but offset by seller fees. May enhance supply chain security through better tracing.
• On International Relations: Strengthens ties with Canada, UK, EU, and Switzerland via mutual agreements; could extend to other nations, promoting global drug safety standards but risking trade tensions if manufacturers challenge import volumes.
• Broader Economy: Might lower overall healthcare spending and drug prices, but could disrupt U.S. manufacturing if imports surge, though safety focus limits risks.

Main Stakeholders Affected

• Consumers and Patients: Primary beneficiaries through cheaper access to essential drugs like insulin and biologics.
• U.S. Pharmacies and Wholesalers: Gain opportunities to import and dispense affordable drugs, potentially increasing competition and profits.
• Foreign Pharmacies and Wholesalers: Certified sellers can access the U.S. market but must comply with FDA standards and pay fees.
• Drug Manufacturers: Face potential revenue losses from parallel imports; prohibited from discriminatory practices, which may require pricing adjustments.
• Government Entities: FDA/HHS for oversight; Congress for monitoring via reports; states retain remedies under non-preemption clause.
• Healthcare Providers: Must issue valid prescriptions for individual imports, ensuring in-person evaluations.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens FDA's regulatory authority over imports while limiting it for compliant personal use under Section 801(d)(1) of the FFDCA. Anti-discrimination provisions could lead to lawsuits against manufacturers for antitrust-like violations (e.g., price discrimination). No preemption preserves state consumer protection laws, potentially enabling varied enforcement. Enhanced penalties for online fraud target rogue sellers without broadly restricting e-commerce.
• Constitutional: No direct challenges apparent; aligns with Congress's commerce clause power to regulate interstate and international trade in drugs. May face scrutiny if seen as compelling speech or contracts via manufacturer restrictions, but these are framed as anti-competitive prohibitions.
• Political: Addresses a bipartisan concern over drug pricing crises, but introduced by Democrats, it could spark debate on "importing socialism" vs. free-market protections. Success depends on FDA implementation; delays or safety issues might fuel opposition from industry lobbying, while cost savings could build public support for further pricing reforms.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Schakowsky, Janice D. [D-IL-9]

Cosponsors (5)

Rep. Cohen, Steve [D-TN-9], Rep. Doggett, Lloyd [D-TX-37], Rep. Omar, Ilhan [D-MN-5], Rep. Pingree, Chellie [D-ME-1], Rep. Pocan, Mark [D-WI-2]

Recent Actions

• 2025-05-01: Referred to the House Committee on Energy and Commerce.
• 2025-05-01: Introduced in House
• 2025-05-01: Introduced in House

Bill Versions

• Affordable and Safe Prescription Drug Importation Act of 2025 — issued 2025-05-01 — PDF (24 pages)