3.0.0 2345 2026-04-24T16:38:14Z 2026-04-24T16:38:14Z Senate S S 2025-07-17 119 https://www.congress.gov/bill/119th-congress/senate-bill/2345 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred To 2025-07-17T19:45:46Z 2025-07-17 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2025-07-17 Introduced in Senate IntroReferral 10000 9 Library of Congress K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN N L000577 Sen. Lee, Mike [R-UT] Mike Lee R UT 2025-07-17 True D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2025-07-17 True G000386 Sen. Grassley, Chuck [R-IA] Chuck Grassley R IA 2025-07-17 True Health Health 2025-09-05T16:35:04Z 00 2025-07-17 Introduced in Senate 2026-04-24T16:33:59Z 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.

]]> Short on Competition Act Display Title 45 Short on Competition Act 2025-07-31T04:23:21Z Short Title(s) as Introduced 101 Short on Competition Act 2025-07-31T04:23:19Z Introduced in Senate IS Official Title as Introduced 6 A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of marginally competitive drug markets and drug shortages. 2025-07-31T04:18:20Z Introduced in Senate IS Introduced in Senate 2025-07-17T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-119s2345is/xml/BILLS-119s2345is.xml 2025-07-17 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.