Pharmaceutical SAVE Act

Summary

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.

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Timeline

1. 28 September 2016

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 28 September 2016

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 28 September 2016 · Official file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 28 September 2016

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 28 September 2016

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 28 September 2016

  Open at official source

Sponsors

• Amy Klobuchar · D · Sponsor
• Mike Lee · R · Sponsor
• · sshr00 · Standing

Related records

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