Congress 108 - HR 4512 - Medicare Prescription Drug Improvement Act

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Summary

Medicare Prescription Drug Improvement Act - Amends title XVIII (Medicare) of the Social Security Act to repeal provisions prohibiting the Secretary of Health and Human Services from interfering with the negotiations between drug manufacturers and pharmacies and prescription drug plan sponsors. Grants the Secretary authority similar to that of the Secretary of Veterans Affairs, Secretary of Defense, and the heads of other Federal agencies and departments that purchase prescription drugs in bulk to negotiate contracts with manufacturers of covered Medicare part D (Voluntary Prescription Drug Benefit Program) drugs.

Eliminates the initial coverage limit on the maximum costs that may be recognized for payment purposes (including the annual deductible) with respect to prescription drug benefits.

Pharmaceutical Market Access Act of 2004 - Amends the Federal Food, Drug and Cosmetic Act to: (1) repeal certain sections of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 relating to importation of prescription drugs from Canada. and (2) restore previous law. Amends such restored law to direct the Secretary to promulgate regulations allowing qualifying individuals (in addition to pharmacists and wholesalers) to import covered products.

Repeals the mandate that the Secretary require that a foreign seller specify the original source of the product and the amount of each lot of the product originally received.

Amends provisions regarding the testing of imported covered products. Declares that specified tests shall not be required unless the importer is a wholesaler. Requires such tests to be conducted by the importer-wholesaler unless a product is a prescription drug subject to the provisions of this Act pertaining to counterfeit-resistant packaging.

Classifies prescription drugs as misbranded if they do not incorporate specified counterfeit-resistant technologies in packaging. Directs the Secretary to require that the packaging of any subject drug incorporate specified overt optically variable counterfeit-resistant technologies.

Actions

Jun 18, 2004

Referred to the Subcommittee on Health.
Jun 10, 2004

Referred to the Subcommittee on Health.
Jun 3, 2004

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Jun 3, 2004

Introduced in House

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