FDA gets power to flood market with cheap foreign drugs during shortages
S. 2345 — Short on Competition Act · Filed by Amy Klobuchar (D-MN) · 3 cosponsors · Introduced Jul 17, 2025 · Referred to committee
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What it does
This bill allows the FDA to temporarily authorize imports of prescription drugs from approved foreign countries when there is a drug shortage or a 'marginally competitive market' (fewer than 5 competitors available for 10+ years after patent expiration). Importers can bring in foreign-approved drugs with the same active ingredient as the shortage drug for up to 3 years, provided the foreign manufacturer commits to seeking U.S. approval. The bill also requires annual reporting on drug shortages and import authorizations.
Why we flagged it
The bill's core mechanism is a temporary import pathway for prescription drugs during shortages or low-competition markets. It is a regulatory flexibility measure designed to increase supply and competition, not a commemorative or appropriations instrument.
What the text implies
- Foreign drug imports may undercut domestic manufacturers' pricing power, potentially reducing R&D investment incentives for new drugs if the import pathway becomes routine rather than emergency-only.
- The 'marginally competitive market' definition (fewer than 5 competitors, 10+ years post-patent) may inadvertently create a loophole for generic manufacturers to avoid competition by discontinuing products, triggering import authority.
The full analysis lists 4 implications of this text.
Who stands to gain
generic drug manufacturers (foreign); drug importers/wholesalers; patients and insurers (lower drug costs)