S. 2345 · Where this bill is now
In committee
Introduced in the Senate, Jul 17, 2025
What this bill does
In plain words · AI-written from the official summaryFDA can authorize importing drugs in short supply
This bill would let the FDA temporarily allow imports of prescription drugs that are in short supply or face weak competition in the U.S. market. To qualify, a drug would need to treat serious conditions, already be approved in other countries, and have a manufacturer willing to seek approval as a generic. The FDA could reject imports only if there were safety or effectiveness concerns, and the imports would stop after three years or once the shortage ended.
How it affects you
If you rely on a prescription drug that's hard to find or in limited supply, this could expand your options by opening the door to safe alternatives from other countries. The bill specifically aims to help with lifesaving medications and drugs for serious conditions, though most people won't be affected unless they face a shortage of the medicine they need.
Read the official 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 AI (Claude) using only the official summary by the Congressional Research Service, the Library of Congress’s nonpartisan research staff. It can miss nuance, so check the official summary and the bill text for details.
1st SessionS. 2345
A BILL
Short on Competition Act
Sponsor: Sen. Amy Klobuchar (D-MN) · Introduced Jul 17, 2025 · Health · 1 version of the text
Sources: Congress.gov actions and votes · bill text from GovInfo · latest official action Jul 17, 2025: “Read twice and referred to the Committee on Health, Education, Labor, and Pensions.”