Skip to main content
S 525 111th Congress Senate Health Administrative law and regulatory procedures Administrative remedies Asia Australia Business records Canada Civil actions and liability Consumer affairs Consumer credit Contracts and agency Department of Health and Human Services Europe European Union Evidence and witnesses Federal Trade Commission (FTC) Federal preemption Food and Drug Administration (FDA) Fraud offenses and financial crimes Government studies and investigations

Pharmaceutical Market Access and Drug Safety Act of 2009

Introduced: March 4, 2009 See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 5, 2009
Sponsor introductory remarks on measure. (CR S2780-2781)
Mar 4, 2009
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 4, 2009
Introduced in Senate
 Plain-English summary Congressional Research Service

Pharmaceutical Market Access and Drug Safety Act of 2009 - 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 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.

What's happening now March 5, 2009

Sponsor introductory remarks on measure. (CR S2780-2781)

 Committees of jurisdiction 1