S.319 - Pharmaceutical Market Access and Drug Safety Act of 2011112th Congress (2011-2012)
Summary: S.319 — 112th Congress (2011-2012)
Introduced in Senate (02/10/2011)
Pharmaceutical Market Access and Drug Safety Act of 2011 - 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 a registered importeror 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.