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Redesignates existing subsections (h), (i), and (j) as (i), (j), and (k), and inserts a new subsection (h) establishing temporary importation authority for certain drugs in shortage, including conditions for authorization, timing (60 days), discretionary denial criteria, and termination after up to 3 years or when shortage ends.
Adds section 506C–2 defining 'marginally competitive drug markets,' treating such markets as creating a drug shortage for purposes of sections 506C(g) and 506C(h), permitting expedited review and authorization of importation, and establishing criteria for determinations (fewer than 5 commercially available reference-listed drugs for at least 2 consecutive months, approval at least 10 years prior, and expiration of patents claiming the active ingredient), plus definitions and rules for 'commercially available.'
Amends reporting requirements in section 506C–1(a)(5)(B) to add a new reporting item requiring the annual report to include the number of drugs authorized for temporary importation under section 506C(h).
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced July 17, 2025 by Amy Klobuchar · Last progress July 17, 2025
Authorizes the FDA Secretary to allow temporary importation of certain prescription drugs from foreign sources for up to three years when a U.S. market is identified as “marginally competitive.” It creates a formal process for identifying those markets, sets timelines and grounds for approval or denial, defines when the authority ends, and requires annual public reporting on how many drugs were authorized under this temporary importation power. The change is targeted at drugs with limited competition to expand supply and ease price/availability pressures by permitting targeted, time-limited imports while preserving the Secretary’s discretion to deny or end authorizations and establishing regulatory criteria and reporting requirements.
Redesignate subsections (h), (i), and (j) of section 506C as subsections (i), (j), and (k), respectively.
Insert a new subsection (h) authorizing the Secretary to permit temporary importation of a drug for up to 3 years when the Secretary concludes there is, or is likely to be, a drug shortage (based on notifications or other information) and specific conditions are met.
Condition A: The drug must be subject to section 503(b)(1), including combination products whose primary mode of action is that of a drug as determined under section 503(g)(1)(D)(i), and not a drug described in subparagraphs (A) through (F) of section 804(a)(3).
Condition B: The drug must be authorized to be lawfully marketed in one or more of the countries on the list under section 802(b)(1).
Condition C: The imported drug must have the same active ingredient as the drug for which there is a shortage with respect to U.S. manufacturers.
Who is affected and how:
Patients and consumers: Likely to benefit from increased availability and potential downward pressure on prices for drugs in narrowly contested markets. Temporary importation could reduce shortages and improve access to treatments that face limited domestic competition.
Drug manufacturers (innovator and generic producers): May face intensified competition and pricing pressure in markets designated as marginally competitive. Some manufacturers could challenge import authorizations legally or adjust pricing/production strategies in response.
Pharmacies, wholesalers, and importers/distributors: Could gain access to additional supply sources but will face compliance obligations to ensure imported products meet U.S. safety and quality standards; foreign sourcing increases supply-chain complexity.
FDA / HHS: Will assume new analytical and administrative duties—identifying marginally competitive markets, evaluating importation petitions or triggers, making timely determinations, and producing annual reports. This will require staff time and expertise, and may prompt development of new guidance and enforcement resources.
Payers and insurers: May see changes in reimbursement dynamics or price negotiation leverage for drugs affected by import authorizations; savings may accrue to public and private payers if importation reduces net costs.
Public health and safety stakeholders: Benefit from built-in discretion allowing denials when quality or safety concerns arise, but increased foreign sourcing could raise oversight burdens and require stricter import inspection and enforcement to mitigate safety risks.
Potential risks and tradeoffs:
Overall effect: A targeted regulatory tool intended to relieve supply and competition problems in narrow drug markets, balanced by agency discretion and reporting obligations; consequences depend on how the agency implements criteria and on market responses by manufacturers and distributors.
Expand sections to see detailed analysis
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate