S2345Referred to Committee

Short on Competition Act

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Introduced
In Committee
3
Passed One Chamber
4
Passed Both
5
Signed into Law
119th
Congress
2025-07-17
Introduced
3
Cosponsors
S
ⓘ
Type

Sponsor

Amy Klobuchar
Amy Klobuchar
Democrat · MN · Senator
Votes with party: 56.0% (323 recorded votes)

Full profile: /officials/K000367

Source: Congress.gov · FEC

Cosponsors (3)

Members who have signed on to support this bill since introduction. Source: Congress.gov.

Latest Action

The most recent step in the bill's legislative path. Committee Activity below shows referrals and reports; the full action-by-action history including floor proceedings lives at Congress.gov →

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

2025-07-17

Source: Congress.gov

Committee Activity

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Plain-English Summary

Short on Competition Act This bill requires the Food and Drug Administration (FDA) to provide temporary authorization to import certain prescription drugs facing shortages or in a marginally competitive drug market. Specifically, the FDA must authorize importation of an eligible drug that is lifesaving, life-sustaining, or intended to treat or prevent a debilitating condition. To be eligible, a drug must (1) be facing a shortage, (2) require a prescription, (3) have received market authorization in certain foreign countries, and (4) have the same active ingredient as the drug for which there is a shortage in the United States. The drug's manufacturer must also seek approval for the drug as a generic drug. The authority to import a drug terminates after three years or when the shortage no longer applies, whichever occurs first. Importation must begin within 60 days of the FDA receiving an application that meets all of the applicable requirements. The FDA may deny importation of a drug for reasons related to safety or effectiveness. Drugs in marginally competitive markets must be treated as being in shortage for the purposes of this bill and may be treated as such for the purposes of expediting inspections and reviewing applications. A drug is in a marginally competitive market if (1) there are fewer than five holders of approved applications for commercially available brand-name or generic versions of the drug, (2) the drug has been approved for at least 10 years, and (3) the patents on the drug's active ingredients have expired.

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

Subjects

Health
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