S. 3455 · 114th Congress
Pharmaceutical Supply and Value Enhancement Act
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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
KlobucharSponsor1 cosponsor · 1 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Pharmaceutical Supply and Value Enhancement Act or the Pharmaceutical SAVE Act
What it does: CRS summary · Introduced in Senate · Sep 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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Pharmaceutical Supply and Value Enhancement Act
Also known as: Pharmaceutical SAVE Act
Latest action (Sep 28, 2016): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Sep 28, 2016
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.