S.2328 - Pharmaceutical Market Access and Drug Safety Act of 2004108th Congress (2003-2004)
Summary: S.2328 — 108th Congress (2003-2004)
Introduced in Senate (04/21/2004)
Pharmaceutical Market Access and Drug Safety Act of 2004 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions governing the importation of prescription drugs. Requires the Secretary of Health and Human Services to promulgate regulations allowing the importation of prescription drugs by registered exporters or registered importers from Canada within 90 days of passage of this Act and from Australia, European Union countries, Japan, New Zealand, or Switzerland within one year.
Provides for inspection, tracking of drugs, and registration and inspection fees for registered importers and exporters.
Requires manufacturers to: (1) submit a statement to the Secretary explaining each difference between a drug approved and distributed in the United States and a related drug distributed in a foreign country; and (2) submit an application to the Food and Drug Administration (FDA) for approval of a related drug that is distributed in a foreign country if there is no comparable drug already approved in at least half of the permitted countries that can be imported to the United States.
Allows for the immediate importation of prescription drugs for personal use from licensed Canadian pharmacies.
Amends the Clayton Act to prohibit drug manufacturers from preventing importation by engaging in behavior such as charging higher prices or limiting supplies to registered exporters and importers or changing the form of the drug for such purpose.
States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement.
Requires the Secretary of Homeland Security to refuse admission of drugs that violate importation provisions. Allows the destruction of certain violative shipments.
Amends the Controlled Substances Act to repeal the exemption that permitted individuals to import controlled substances for personal medical use.