US SB183 | 2017-2018 | 115th Congress
Status
Spectrum: Bipartisan Bill
Status: Introduced on January 20 2017 - 25% progression, died in committee
Action: 2017-01-20 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on January 20 2017 - 25% progression, died in committee
Action: 2017-01-20 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]
Summary
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.
Title
Short on Competition Act
Sponsors
Sen. Amy Klobuchar [D-MN] | Sen. Mike Lee [R-UT] | Sen. Richard Durbin [D-IL] | Sen. Chuck Grassley [R-IA] |
History
Date | Chamber | Action |
---|---|---|
2017-01-20 | Senate | Read twice and referred to the Committee on Health, Education, Labor, and Pensions. |
Subjects
Congressional oversight
Drug safety, medical device, and laboratory regulation
Health
Prescription drugs
Trade restrictions
Drug safety, medical device, and laboratory regulation
Health
Prescription drugs
Trade restrictions
US Congress State Sources
Type | Source |
---|---|
Summary | https://www.congress.gov/bill/115th-congress/senate-bill/183/all-info |
Text | https://www.congress.gov/115/bills/s183/BILLS-115s183is.pdf |