Pharmaceutical Export Amendments of 1986

Summary

Pharmaceutical Export Amendments of 1985 - Amends the Federal Food, Drug, and Cosmetic Act to permit the export of certain drugs (including biological products) intended for human or animal use even though such drugs have not been approved or licensed for use in the United States. Directs the Secretary of Health and Human Services to establish and update a two-tiered list of countries with adequate governmental health authorities which in the first tier includes developed regulatory procedures and tests with experienced scientific personnel and in the second tier includes sufficient ability to assure consistency of labeling information. Permits shipments to nonlist countries where differing health conditions make such shipments desirable, e.g. tropical diseases. Permits the export of an unapproved drug to a second tier country if such drug is approved for use in any first-tier country and not banned for use in any first-tier country. Prohibits the export of drugs denied approval on the basis of safety and efficacy or whose manufacture in the United States has been determined to be contrary to U.S. health and safety. Sets forth other criteria and restrictions on the export of such drugs, including notice requirements on shipments and notice of and opportunity to cure deficiencies in such shipments. Permits the Secretaries of Agriculture and Health and Human Services to prohibit noncomplying shipments and shipments otherwise permitted if either Secretary determines a shipment would present an imminent hazard to the public health of the recipient country. Requires the Comptroller General to report biennially to the Secretary of Health and Human Services and the Congress on the extent to which drugs unauthorized for a country are being received by such country and the extent to which labeling is consistent. Directs the Secretary to contract for a study to be submitted to the Congress within five years on the economic and international health impact of this Act. Includes condition prevalent in a developing country among the criteria for orphan drugs.

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Timeline

1. 13 November 1985

   Introduced

   Read twice and referred to the Committee on Labor and Human Resources.

   Source: IntroReferral

2. 13 November 1985

   Introduced

   Introduced in Senate

   Source: IntroReferral

3. 19 November 1985

   Reported

   Committee on Labor and Human Resources. Ordered to be reported with an amendment in the nature of a substitute favorably.

   Source: Committee

4. 18 December 1985

   Calendars

   Placed on Senate Legislative Calendar under General Orders. Calendar No. 493.

   Source: Calendars

5. 18 December 1985

   Reported

   Committee on Labor and Human Resources. Reported to Senate by Senator Hatch with an amendment in the nature of a substitute. With written report No. 99-225. Minority views filed.

   Source: Committee

6. 18 December 1985

   Reported

   Committee on Labor and Human Resources. Reported to Senate by Senator Hatch with an amendment in the nature of a substitute. With written report No. 99-225. Minority views filed.

   Source: Committee

7. 8 May 1986

   Floor

   Measure laid before Senate by unanimous consent.

   Source: Floor

8. 12 May 1986

   Floor

   Considered by Senate.

   Source: Floor

9. 13 May 1986

   Floor

   Considered by Senate.

   Source: Floor

10. 14 May 1986

    Floor

    Considered by Senate.

    Source: Floor

11. 14 May 1986

    Vote

    Passed/agreed to in Senate: Passed Senate with amendments by Yea-Nay Vote. 91-7. Record Vote No: 99.

    Source: Floor

12. 20 May 1986

    Introduced

    Referred to House Committee on Foreign Affairs.

    Source: IntroReferral

13. 22 May 1986

    Referred

    Referred to Subcommittee on Health and the Environment.

    Source: Committee

14. 30 May 1986

    Referred

    Referred to Subcommittee on International Economic Policy and Trade.

    Source: Committee

15. 18 October 1986

    Committee

    Provisions of This Bill Were Incorporated in S.1744.

    Source: Committee

Votes

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

3 official files

• Passed Senate amended

  summary · EN · 14 May 1986

  Open at official source

• Reported to Senate with amendment(s)

  summary · EN · 18 December 1985

  Open at official source

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• Introduced in Senate

  summary · EN · 13 November 1985

  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. Hatch, Orrin G. [R-UT] · R · Sponsor
• Sen. Kennedy, Edward M. [D-MA] · D · Sponsor
• Sen. Thurmond, Strom [R-SC] · R · Sponsor
• Sen. Hawkins, Paula [R-FL] · R · Sponsor
• Sen. Lautenberg, Frank R. [D-NJ] · D · Sponsor
• Sen. Bradley, Bill [D-NJ] · D · Sponsor
• Sen. Quayle, Dan [R-IN] · R · Sponsor
• Sen. Dodd, Christopher J. [D-CT] · D · Sponsor
• Sen. Nickles, Don [R-OK] · R · Cosponsor
• Sen. McConnell, Mitch [R-KY] · R · Cosponsor
• Sen. Gorton, Slade [R-WA] · R · Cosponsor
• Sen. Symms, Steven D. [R-ID] · R · Cosponsor
• Sen. Durenberger, Dave [R-MN] · R · Cosponsor
• Sen. Baucus, Max [D-MT] · D · Cosponsor
• Sen. Simon, Paul [D-IL] · D · Cosponsor
• Sen. Kasten, Robert W., Jr. [R-WI] · R · Cosponsor
• Sen. Lugar, Richard G. [R-IN] · R · Cosponsor
• Sen. D'Amato, Alfonse [R-NY] · R · Cosponsor
• · hsfa00 · Standing
• · hsif00 · Standing
• · sshr00 · Standing

Related records

• related to ← State Comprehensive Mental Health Services Plan Act of 1986
• amends ← To amend the Federal Food, Drug, and Cosmetic Act to require that the label of all drugs disclose the active and inactive ingredients in the drug.
• amends ← To prohibit the shipment to tier II countries of a drug which has been withdrawn from sale or use in a tier I country.
• amends ← To prohibit the export of a drug which is approved for use in the United States if the manufacturer of the drug changes the labeling of the drug from the labeling permitted to be used in the United States.
• amends ← To require that, to be exported, any unapproved drug must be the subject of a new drug application.
• amends ← To eliminate the shipment of drugs to tier II countries, and to require that tier I countries have standards and procedures for determining the safety and effectiveness of drugs which are similar to the standards and procedures specified in section 505.
• amends ← To require the appointment of the Commissioner of Food and Drugs to be subject to Senate confirmation.
• amends ← To require that the same conditions apply to the export of antibiotic drugs as apply to other drugs.

Showing 8 of 36 related records.