Drug Price Competition and Patent Term Restoration Act of 1984

Summary

Drug Price Competition Act of 1983 - Amends the Federal Food, Drug, and Cosmetic Act to exempt from Food and Drug Administration (FDA) clinical application requirements new drugs that are the same as previously approved new drugs (extends FDA abbreviated drug application procedures to post-1962 new generic drugs).

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

Timeline

1. 19 July 1983

   Introduced

   Referred to House Committee on Energy and Commerce.

   Source: IntroReferral

2. 19 July 1983

   Introduced

   Introduced in House

   Source: IntroReferral

3. 19 July 1983

   Introduced

   Introduced in House

   Source: IntroReferral

4. 21 July 1983

   Referred

   Referred to Subcommittee on Health and the Environment.

   Source: Committee

5. 25 July 1983

   Committee

   Subcommittee Hearings Held.

   Source: Committee

6. 2 August 1983

   Committee

   Forwarded by Subcommittee to Full Committee.

   Source: Committee

7. 2 August 1983

   Committee

   Subcommittee Consideration and Mark-up Session Held.

   Source: Committee

8. 12 June 1984

   Reported

   Ordered to be Reported (Amended) by Voice Vote.

   Source: Committee

9. 12 June 1984

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

10. 21 June 1984

    Introduced

    Referred to House Committee on The Judiciary Sequentially, for a Period Ending not Later than Aug 1, 84.

    Source: IntroReferral

11. 21 June 1984

    Reported

    Reported to House (Amended) by House Committee on Energy and Commerce. Report No: 98-857 (Part I).

    Source: Committee

12. 21 June 1984

    Reported

    Reported to House (Amended) by House Committee on Energy and Commerce. Report No: 98-857 (Part I).

    Source: Committee

13. 25 June 1984

    Referred

    Referred to Subcommittee on Courts, Civil Liberties, and the Administration of Justice.

    Source: Committee

14. 27 June 1984

    Committee

    Subcommittee Hearings Held.

    Source: Committee

15. 25 July 1984

    Committee

    Forwarded by Subcommittee to Full Committee (Amended).

    Source: Committee

16. 25 July 1984

    Committee

    Subcommittee Consideration and Mark-up Session Held.

    Source: Committee

17. 31 July 1984

    Reported

    Ordered to be Reported (Amended).

    Source: Committee

18. 31 July 1984

    Committee

    Committee Consideration and Mark-up Session Held.

    Source: Committee

19. 1 August 1984

    Calendars

    Placed on Union Calendar No: 531.

    Source: Calendars

20. 1 August 1984

    Reported

    Reported to House (Amended) by House Committee on The Judiciary. Report No: 98-857 (Part II).

    Source: Committee

21. 1 August 1984

    Reported

    Reported to House (Amended) by House Committee on The Judiciary. Report No: 98-857 (Part II).

    Source: Committee

22. 8 August 1984

    Floor

    Called up by House by Rule.

    Source: Floor

23. 8 August 1984

    Passed

    Rule Passed House.

    Source: Floor

24. 8 August 1984

    Reported

    Rules Committee Resolution H.Res.569 Reported to House.

    Source: Floor

25. 8 August 1984

    Floor

    Committee on Rules Granted an Open Rule Providing Two Hours of General Debate; Making in Order the Energy and Commerce Committee Amendment in the Nature of a Substitute now Printed in the Bill as Original Text for the Purposes of Amendment; Waiving all Points of Order Against the Amendment for Failure to Comply with the Provisions of Clause 7, Rule XVI.

    Source: Floor

26. 6 September 1984

    Floor

    Laid on Table in House by Voice Vote.

    Source: Floor

27. 6 September 1984

    Vote

    Passed House (Amended) by Yea-Nay Vote: 362 - 0 (Record Vote No: 379).

    Source: Floor

28. 6 September 1984

    Vote

    Passed/agreed to in House: Passed House (Amended) by Yea-Nay Vote: 362 - 0 (Record Vote No: 379).

    Source: Floor

29. 6 September 1984

    Passed

    House Agreed to Amendments Adopted by the Committee of the Whole.

    Source: Floor

30. 6 September 1984

    Floor

    Committee Amendment in the Nature of a Substitute Considered as an Original Bill for the Purpose of Amendment.

    Source: Floor

Votes

No vote records are attached yet.

Versions

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

Documents

4 official files

• Passed House amended

  summary · EN · 6 September 1984

  Open at official source

• Reported to House amended, Part II

  summary · EN · 1 August 1984

  Open at official source

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  Vertaal document

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• Reported to House amended, Part I

  summary · EN · 21 June 1984

  Open at official source

  Leesvertaling

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  Vertaal document

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

• Introduced in House

  summary · EN · 19 July 1983

  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

• Rep. Waxman, Henry A. [D-CA-33] · D · Sponsor
• Rep. Madigan, Edward R. [R-IL-15] · R · Sponsor
• Sen. Wyden, Ron [D-OR] · D · Sponsor
• Rep. Sikorski, Gerry E. [D-MN-6] · D · Sponsor
• Sen. Wirth, Timothy [D-CO] · D · Sponsor
• Rep. Leland, Mickey [D-TX-18] · D · Sponsor
• Sen. Markey, Edward J. [D-MA] · D · Sponsor
• Rep. Swift, Al [D-WA-2] · D · Sponsor
• Rep. Bryant, John W. [D-TX-5] · D · Sponsor
• Rep. Weiss, Ted [D-NY-17] · D · Sponsor
• Sen. Gore, Albert, Jr. [D-TN] · D · Cosponsor
• Rep. Kaptur, Marcy [D-OH-9] · D · Cosponsor
• Rep. Owens, Major R. [D-NY-11] · D · Cosponsor
• Rep. Martinez, Matthew G. [D-CA-31] · D · Cosponsor
• Rep. Bedell, Berkley W. [D-IA-6] · D · Cosponsor
• Rep. Synar, Mike [D-OK-2] · D · Cosponsor
• · hsju00 · Standing
• · hsif00 · Standing

Related records

• related to → A resolution providing for the consideration of the bill (H.R. 3605) to amend the Federal Food, Drug, and Cosmetic Act to authorize an abbreviated new drug application under section 505 of that Act for generic new drugs equivalent to approved new drugs.
• related to ← An act to amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug applications, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes.
• amends ← An amendment to strike the language of title I, substituting the language of S. 2926, Drug Price Competition and Patent Term Restoration Act of 1984. Title I is entitled "Abbreviated New Drug Applications".
• amends ← An amendment to refquire country of origin labels on domestically produced, as well as imported, merchandise as regards to their textile origin. The amendment specifies that the item and its package must be labeled, or the package must be transparent such that the label on the item is clearly visible. In the case of hosiery items only the package must be labeled. Labels must be on the collars of items with collars. The amendment has language for "textile fiber products" and for wool products. Products will be considered falsely or deceptively presented if they do not conform to these standards. Also mail order catalogues for such items must state the country of origin of the fiber.
• amends ← An amendment to strike the language if Title II and substitute the language of Title II of S.2936, Drug Price Competition and Patent Term Restoration Act of 1984. Title II is entitled "Patent Extension".
• amends ← An amendment to the Waxman amendment to change the period for approval of generic drugs from 30 months to 18 months.
• amends ← An amendment to the Waxman amendment to specify that the bill applies only to prescription drugs.
• amends ← An amendment to the Derrick amendment, as amended, to change the effective date of the Title III (Fiber Content Provisions) from 90 days to 180 days from the date of the bill's enactment.
• amends ← An amendment to the Derrick amendment, as amended, to strike language that requires that textile fiber products advertised in mail order promotional materials must show if they are imported. It retains language that requires the material to show the origin of items when they are made in the U.S.

Showing 9 of 12 related records.