S 2345 · 119th Congress · Health

Short on Competition Act

Introduced 2025-07-17· Sponsored by Sen. Klobuchar, Amy [D-MN]· Senate

Bill Progress

Introduced
2
Committee
3
Senate Vote
4
House
5
Enacted
Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.(2025-07-17)

Plain Language Summary

[AI summary unavailable — showing source text] 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 purpos…

Summarized by Claude AI · Non-partisan · For informational purposes only

Cosponsors (3)

1 Democrat2 Republicans