Pharmaceutical Market Access and Drug Safety Act of 2009

Bill: 111-s-525
Sponsor: Sen. Dorgan, Byron L. [D-ND]
Introduced: 2009-03-04 in the Senate
Policy area: Health
Subjects: 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
Health information and medical records
Intellectual property
Intergovernmental relations
Internet and video services
Internet, web applications, social media
Japan
Marketing and advertising
Medical education
Medical tests and diagnostic methods
New Zealand
Oceania
Prescription drugs
Product safety and quality
Retail and wholesale trades
Switzerland
Trade restrictions
User charges and fees

Summary:
action_date: 2009-03-04
text: 
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.


Legislative actions:
action_date: 2009-03-05
text: Sponsor introductory remarks on measure. (CR S2780-2781)
action_date: 2009-03-04
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2009-03-04
text: Introduced in Senate