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A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of noncompetitive drug markets and drug shortages.

USA115th CongressS-183| Senate 
| Updated: 1/20/2017
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 amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to authorize importation of life-saving drugs for which there is, or is likely to be, a shortage. For a drug to be imported, the drug's manufacturer must intend to seek FDA approval of the drug as a generic drug. The FDA may deny importation of a drug for reasons related to safety or effectiveness. Drugs in noncompetitive markets must be treated as being in a shortage for purposes of this bill and for purposes of expedited inspections and review. A drug is in a noncompetitive 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) patents on the active ingredient of the drug have expired.
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Timeline
Jan 20, 2017
Introduced in Senate
Jan 20, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 20, 2017
    Introduced in Senate


  • January 20, 2017
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

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

A bill to allow for expedited approval of generic prescription drugs and temporary importation of prescription drugs in the case of noncompetitive drug markets and drug shortages.

USA115th CongressS-183| Senate 
| Updated: 1/20/2017
Short on Competition Act This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to authorize importation of life-saving drugs for which there is, or is likely to be, a shortage. For a drug to be imported, the drug's manufacturer must intend to seek FDA approval of the drug as a generic drug. The FDA may deny importation of a drug for reasons related to safety or effectiveness. Drugs in noncompetitive markets must be treated as being in a shortage for purposes of this bill and for purposes of expedited inspections and review. A drug is in a noncompetitive 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) patents on the active ingredient of the drug have expired.
View Full Text

Suggested Questions

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Timeline
Jan 20, 2017
Introduced in Senate
Jan 20, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • January 20, 2017
    Introduced in Senate


  • January 20, 2017
    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