Pharmaceutical Market Access and Drug Safety Act of 2004

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 21 April 2004

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 21 April 2004

   Introduced

   Sponsor introductory remarks on measure. (CR S4227-4228)

   Source: IntroReferral

3. 21 April 2004

   Introduced

   Introduced in Senate

   Source: IntroReferral

4. 20 May 2004

   Committee

   Committee on Health, Education, Labor, and Pensions. Hearings held. Hearings printed: S.Hrg. 108-470.

   Source: Committee

5. 14 July 2004

   Committee

   Committee on the Judiciary. Hearings held.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 21 April 2004 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 21 April 2004

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 21 April 2004

  ViewDownloadOpen at official source

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• Introduced in Senate

  summary · EN · 21 April 2004

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Sen. Dorgan, Byron L. [D-ND] · D · Sponsor
• Sen. Snowe, Olympia J. [R-ME] · R · Sponsor
• Sen. Kennedy, Edward M. [D-MA] · D · Sponsor
• Sen. McCain, John [R-AZ] · R · Sponsor
• Sen. Daschle, Thomas A. [D-SD] · D · Sponsor
• Sen. Lott, Trent [R-MS] · R · Sponsor
• Sen. Stabenow, Debbie [D-MI] · D · Sponsor
• Sen. Chafee, Lincoln [R-RI] · R · Sponsor
• Sen. Johnson, Tim [D-SD] · D · Sponsor
• Sen. Pryor, Mark L. [D-AR] · D · Sponsor
• Sen. Feingold, Russell D. [D-WI] · D · Sponsor
• Sen. Dayton, Mark [D-MN] · D · Cosponsor
• Sen. Schumer, Charles E. [D-NY] · D · Cosponsor
• Sen. Feinstein, Dianne [D-CA] · D · Cosponsor
• Sen. Nelson, Bill [D-FL] · D · Cosponsor
• Sen. Kerry, John F. [D-MA] · D · Cosponsor
• Sen. Leahy, Patrick J. [D-VT] · D · Cosponsor
• Sen. Durbin, Richard J. [D-IL] · D · Cosponsor
• Sen. Boxer, Barbara [D-CA] · D · Cosponsor
• Sen. Mikulski, Barbara A. [D-MD] · D · Cosponsor
• Sen. Levin, Carl [D-MI] · D · Cosponsor
• Sen. Kohl, Herb [D-WI] · D · Cosponsor
• Sen. Inouye, Daniel K. [D-HI] · D · Cosponsor
• Sen. Clinton, Hillary Rodham [D-NY] · D · Cosponsor
• Sen. Lincoln, Blanche L. [D-AR] · D · Cosponsor
• Sen. Specter, Arlen [R-PA] · R · Cosponsor
• Sen. Jeffords, James M. [I-VT] · I · Cosponsor
• Sen. Edwards, John [D-NC] · D · Cosponsor
• Sen. Reid, Harry [D-NV] · D · Cosponsor
• Sen. Conrad, Kent [D-ND] · D · Cosponsor
• Sen. Sarbanes, Paul S. [D-MD] · D · Cosponsor
• Sen. Dodd, Christopher J. [D-CT] · D · Cosponsor
• · ssju00 · Standing
• · sshr00 · Standing

Related records

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