S.3455 - Pharmaceutical Supply and Value Enhancement Act114th Congress (2015-2016)
|Sponsor:||Sen. Klobuchar, Amy [D-MN] (Introduced 09/28/2016)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||Senate - 09/28/2016 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions)|
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Summary: S.3455 — 114th Congress (2015-2016)All Information (Except Text)
Introduced in Senate (09/28/2016)
Pharmaceutical Supply and Value Enhancement Act or the Pharmaceutical SAVE 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.