S. 319 Pharmaceutical Market Access and Drug Safety Act of 2011
LEGISLATIVE INFORMATION PAGE
Bill Number: S. 319
Title: Pharmaceutical Market Access and Drug Safety Act of 2011
Primary Sponsor: Snowe (R-Maine)
Introduced: 2/10/11; Referred to HELP Committee
Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs:
- Waives the limitation on re-importation of prescription drugs.
- Prohibits the importation of a qualifying drug unless such drug is imported by a registered importer or an individual for personal use.
- Establishes registration conditions for importers and exporters.
- Requires the Secretary of HHS to inspect places of business, verify chains of custody, inspect facilities, and determine compliance.
- Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs.
- 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 from one distributed elsewhere; (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 determines discriminates against a person that engages or attempts to engage in importation.
- 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 importation.
- Sets forth provisions governing the sale of prescription drugs through an Internet site.
|CHI Position:||Learn More about S. 319:|
California Delegation Co-sponsors: