Pharmaceutical Market Access and Drug Safety Act of 2004

[AI summary unavailable — showing source text] 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 Cana…