S. 2345 · 119th Congress
Short on Competition Act
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D
KlobucharSponsor3 cosponsors · 1 D, 2 R
3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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.
What it does: CRS summary · Introduced in Senate · Jul 17, 2025
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Short on Competition Act
Latest action (Jul 17, 2025): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Jul 17, 2025
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.