legislation: 114-s-3455

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bill_id congress bill_type bill_number title policy_area introduced_date latest_action_date latest_action_text origin_chamber sponsor_name sponsor_state sponsor_party sponsor_bioguide_id cosponsor_count summary_text update_date url
114-s-3455 114 s 3455 Pharmaceutical Supply and Value Enhancement Act Health 2016-09-28 2016-09-28 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Senate Sen. Klobuchar, Amy [D-MN] MN D K000367 1 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. 2023-01-11T13:33:30Z  

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