S 183
115th Congress
Senate
Health
Congressional oversight
Drug safety, medical device, and laboratory regulation
Prescription drugs
Trade restrictions
Short on Competition Act
Introduced: January 20, 2017
Introduced by:
Klobuchar, Amy
Democratic
· Minnesota
See on congress.gov
Everywhere this bill has been
2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jan 20, 2017
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jan 20, 2017
Introduced in Senate
Plain-English 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.
What's happening now
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committees of jurisdiction
1