118th Congress Health
S. 845: Short on Competition Act
Introduced
- Introduced (completed)
- Passed Senate (not reached)
- Passed House (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
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 shall 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 FDA approval for the drug as a generic drug.
The import authorization shall be for three years or until the shortage no longer applies, whichever occurs first. Importation shall 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.
Read the full summary
Drugs in marginally competitive markets must be treated as being in a shortage for the purposes of this bill and for the purposes of expedited inspections and review. 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 Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- Richard Durbin D-ILOriginal
- Charles Grassley R-IAOriginal
- Mike Lee R-UTOriginal
Who scored on this bill
- 1Amy Klobuchar SponsorDrew cross-party cosponsors, introduced2 events+6
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Introductions and cosponsorships count toward weekly caps and show no points.
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History
- Introduced in the Senate by Amy Klobuchar.
Show the full action history (2 actions)
- Introduced in Senate
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions.