Generic Animal Drug and Patent Term Restoration Act

Summary

Generic Animal Drug and Patent Term Restoration Act - Title I: New Animal Drug Applications - Amends the Federal Food, Drug, and Cosmetic Act to authorize abbreviated applications for the approval of a new animal drug. Requires such application to show that permitted uses, ingredients, dosages, labeling, and other factors are the same as or bioequivalent to a new animal drug already approved. Requires such application to contain a certification relating to patents covering the approved drug. Requires an applicant who makes such a certification to state in the application that a specified notice has been given to each owner of the patent (or owner-representative) and the holder (or holder-representative) of the approved application for the drug or drug use claimed by the patent. Requires the permission of the Secretary of Health and Human Services before an abbreviated application may be submitted for a new drug whose route of administration, dosage form, or strength differ from that of an approved new animal drug or whose use with other animal drugs in animal feed differs from that of an approved new animal drug. Requires the Secretary to publish and update a list of the official and proprietary name of each new animal drug which has been approved and continues to be approved for safety and effectiveness, including patent information as it comes in. Directs the Secretary to approve an application for a drug unless the Secretary makes specified findings, such as faulty manufacture or insufficient information. Sets forth a formula for determining when an approved application becomes effective, based upon the nature of the certification relating to patents. Prohibits an abbreviated application for a new animal drug based upon a nonabbreviated application approved after this Act's enactment until five years after the nonabbreviated application is approved, except as specified. Requires a three-year wait for abbreviated applications based upon nonabbreviated applications approved after this Act's enactment which contain essential new investigations of an ingredient already approved. Requires the applicant to file with the application (or amend it when the information becomes available) the patent number and the expiration date of any patent which claims the drug or a method of using it and with respect to which a claim of patent infringement could reasonably be asserted if a nonlicensee engaged in the drug's manufacture, use, or sale. Requires the Secretary to disapprove the application if it does not contain certain patent information, or to withdraw approval if the patent information was not filed within a specified time after notification. Requires that safety and effectiveness data be made available to the public, except as specified. Provides for the promulgation of regulations to administer the amendments made by this title. Prohibits the dispensing of certain drugs for animal use without a prescription. Deems the act of dispensing a drug in violation of this Act to be an act resulting in misbranding while the drug is held for sale. Specifies that such drugs are considered misbranded if their labels fail to bear the statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian." Title II: Patent Terms - Amends the patent laws to include animal drugs under the patent extension provisions applicable to human drugs which compensate for regulatory delays.

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

Timeline

1. 7 July 1988

   Introduced

   Referred to House Committee on Energy and Commerce.

   Source: IntroReferral

2. 7 July 1988

   Committee

   For Previous Action See H.R.3120.

   Source: Committee

3. 7 July 1988

   Introduced

   Introduced in House

   Source: IntroReferral

4. 7 July 1988

   Introduced

   Introduced in House

   Source: IntroReferral

5. 11 July 1988

   Referred

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

   Source: Committee

6. 9 August 1988

   Reported

   Ordered to be Reported.

   Source: Committee

7. 9 August 1988

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

8. 1 September 1988

   Committee

   Executive Comment Requested from Commerce.

   Source: Committee

9. 14 September 1988

   Committee

   Subcommittee Hearings Held.

   Source: Committee

10. 22 September 1988

    Committee

    Forwarded by Subcommittee to Full Committee (Amended).

    Source: Committee

11. 22 September 1988

    Committee

    Subcommittee Consideration and Mark-up Session Held.

    Source: Committee

12. 23 September 1988

    Reported

    Reported to House by House Committee on Energy and Commerce. Report No: 100-972.

    Source: Committee

13. 23 September 1988

    Reported

    Reported to House by House Committee on Energy and Commerce. Report No: 100-972.

    Source: Committee

14. 27 September 1988

    Reported

    Ordered to be Reported (Amended).

    Source: Committee

15. 27 September 1988

    Committee

    Committee Consideration and Mark-up Session Held.

    Source: Committee

16. 29 September 1988

    Reported

    Reported to House (Amended) by House Committee on The Judiciary. Report No: 100-972 (Part II).

    Source: Committee

17. 29 September 1988

    Reported

    Reported to House (Amended) by House Committee on The Judiciary. Report No: 100-972 (Part II).

    Source: Committee

18. 29 September 1988

    Calendars

    Placed on Union Calendar No: 597.

    Source: Calendars

19. 6 October 1988

    Introduced

    Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 1123.

    Source: Calendars

20. 6 October 1988

    Passed

    Passed House (Amended) by Voice Vote.

    Source: Floor

21. 6 October 1988

    Floor

    Called up by House Under Suspension of Rules.

    Source: Floor

22. 6 October 1988

    Passed

    Passed/agreed to in House: Passed House (Amended) by Voice Vote.

    Source: Floor

23. 13 October 1988

    Passed

    S. 2843 passed in Senate relating to this measure.

    Source: Floor

24. 21 October 1988

    Floor

    Indefinitely postponed by Senate by Unanimous Consent.

    Source: Floor

Votes

No vote records are attached yet.

Versions

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

Documents

2 official files

• Passed House amended

  summary · EN · 6 October 1988

  Open at official source

• Introduced in House

  summary · EN · 7 July 1988

  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. Tauke, Thomas Joseph [R-IA-2] · R · Sponsor
• Rep. Waxman, Henry A. [D-CA-33] · D · Sponsor
• Rep. Kastenmeier, Robert W. [D-WI-2] · D · Sponsor
• Rep. Hughes, William J. [D-NJ-2] · D · Cosponsor
• · hsju00 · Standing
• · hsif00 · Standing

Related records

• related to → Generic Animal Drug and Patent Term Restoration Act
• related to → Animal Drug Amendments and Patent Term Restoration Act of 1988
• related to ← Generic Animal Drug and Patent Term Restoration Act