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Short on Competition Act

USA116th CongressS-844| Senate 
| Updated: 3/14/2019
Amy Klobuchar

Amy Klobuchar

Democratic Senator

Minnesota

Cosponsors (3)
Richard J. Durbin (Democratic)Mike Lee (Republican)Chuck Grassley (Republican)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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 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. 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.
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Timeline
Mar 14, 2019
Introduced in Senate
Mar 14, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • March 14, 2019
    Introduced in Senate


  • March 14, 2019
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Congressional oversightDrug safety, medical device, and laboratory regulationPrescription drugsTrade restrictions

Short on Competition Act

USA116th CongressS-844| Senate 
| Updated: 3/14/2019
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 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. 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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Mar 14, 2019
Introduced in Senate
Mar 14, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • March 14, 2019
    Introduced in Senate


  • March 14, 2019
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Amy Klobuchar

Amy Klobuchar

Democratic Senator

Minnesota

Cosponsors (3)
Richard J. Durbin (Democratic)Mike Lee (Republican)Chuck Grassley (Republican)

Health, Education, Labor, and Pensions Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightDrug safety, medical device, and laboratory regulationPrescription drugsTrade restrictions