S.3415 - Fair Pricing for Prescription Drugs Act

A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs and to amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries. view all titles (3)

All Bill Titles

  • Official: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs and to amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries. as introduced.
  • Short: Fair Pricing for Prescription Drugs Act as introduced.
  • Short: Pharmaceutical Market Access and Drug Safety Act of 2010 as introduced.

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05/25/10
 
 
 
 
 
 
 

Official Summary

Fair Pricing for Prescription Drugs Act - Pharmaceutical Market Access and Drug Safety Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that

Official Summary

Fair Pricing for Prescription Drugs Act - Pharmaceutical Market Access and Drug Safety Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States. Prohibits the importation of a qualifying drug unless such drug is imported by:
(1) a registered importer; or
(2) an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary of Health and Human Services (HHS) to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions. Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences. Prohibits manufacturers from:
(1) discriminating against registered exporters or importers;
(2) causing there to be a difference in a prescription drug distributed in the United States and one distributed in a permitted country;
(3) engaging in actions to restrict, prohibit, or delay the importation of a qualifying drug; or
(4) engaging in any action that the Federal Trade Commission (FTC) determines discriminates against a person that engages or attempts to engage in the importation of a qualifying drug. States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement. Requires the Secretary to educate consumers regarding prescription drug importation. Sets forth provisions governing the sale of prescription drugs through an Internet site. Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under FFDCA. Prohibits the introduction of restricted transactions with unregistered foreign pharmacies into a payment system or the completion of such transactions using a payment system. Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to direct the Secretary to negotiate with pharmaceutical manufacturers the prices that may be charged to Medicare part D prescription drug plan (PDP) sponsors and MedicareAdvantage (MA) organizations for covered part D drugs for part D eligible individuals who are enrolled under a PDP or an MA-Prescription Drug plan.

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