Orphan Drug Amendments of 1985

Summary

Orphan Drug Amendments of 1985 - Amends the Federal Food, Drug, and Cosmetic Act to repeal the requirement that exclusive marketing rights may only be granted to an orphan drug (a drug used in the treatment of a rare disease or condition) if the drug is not patentable. Establishes a National Commission on Orphan Diseases. Requires the Commission to assess the activities of the National Institutes of Health, the Alcohol, Drug Abuse, and Mental Health Administration, the Food and Drug Administration, other public agencies, and private entities in connection with: (1) basic research relating to rare diseases; (2) the use in research on rare diseases of knowledge developed in other research; (3) applied and clinical research relating to the prevention, diagnosis, and treatment of rare diseases; and (4) the dissemination of knowledge developed in research relating to rare diseases. Requires the Commission to submit a report by September 30, 1987, to the Secretary of Health and Human Services and to each House of the Congress containing the Commission's findings, conclusions, and recommendations. Makes funds available to the Commission. Terminates the Commission 90 days after the date of such report. Amends the Orphan Drug Act to allow Federal grants and contracts for preclinical and human clinical testing of orphan drugs. Authorizes appropriations for such grants and contracts for FY 1986 through 1988. Makes technical corrections to the Departments of Labor, Health and Human Services, Education and Related Appropriation Act, 1985 in order to allow the expenditure of funds for personnel training under the Education of the Handicapped Act until September 30, 1985.

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

Timeline

1. 15 May 1985

   Introduced

   Introduced in the Senate, read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 135.

   Source: Calendars

2. 15 May 1985

   Introduced

   Introduced in Senate

   Source: IntroReferral

3. 23 May 1985

   Passed

   Passed Senate without amendment by Voice Vote.

   Source: Floor

4. 23 May 1985

   Passed

   Passed/agreed to in Senate: Passed Senate without amendment by Voice Vote.

   Source: Floor

5. 18 June 1985

   Passed

   Passed House (Amended) by Voice Vote.

   Source: Floor

6. 18 June 1985

   Passed

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

   Source: Floor

7. 18 June 1985

   Floor

   Called up by House by Unanimous Consent.

   Source: Floor

8. 25 July 1985

   ResolvingDifferences

   Senate concurred in the House amendment with amendments (SP 546) by Voice Vote.

   Source: ResolvingDifferences

9. 25 July 1985

   NotUsed

   Resolving differences -- Senate actions: Senate concurred in the House amendment with amendments (SP 546) by Voice Vote.

   Source: NotUsed

10. 25 July 1985

    Floor

    Considered by Senate.

    Source: Floor

11. 31 July 1985

    Passed

    House Agreed to Senate Amendments to House Amendments by Voice Vote.

    Source: ResolvingDifferences

12. 31 July 1985

    Passed

    Resolving differences -- House actions: House Agreed to Senate Amendments to House Amendments by Voice Vote.

    Source: NotUsed

13. 7 August 1985

    Floor

    Presented to President.

    Source: Floor

14. 7 August 1985

    President

    Presented to President.

    Source: President

15. 7 August 1985

    Floor

    Measure Signed in Senate.

    Source: Floor

16. 15 August 1985

    Became law

    Became Public Law No: 99-91.

    Source: President

17. 15 August 1985

    Became law

    Signed by President.

    Source: BecameLaw

18. 15 August 1985

    President

    Signed by President.

    Source: President

Votes

No vote records are attached yet.

Versions

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

Documents

4 official files

• Public Law (PDF)

  Public Law · EN · 16 August 1985

  ViewDownloadOpen at official source

• Senate agreed to House amendment with amendment

  summary · EN · 25 July 1985

  Open at official source

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• Passed House amended

  summary · EN · 18 June 1985

  Open at official source

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  Vertaal document

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• Introduced in Senate

  summary · EN · 15 May 1985

  Open at official source

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  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. Kassebaum, Nancy Landon [R-KS] · R · Sponsor
• Sen. Quayle, Dan [R-IN] · R · Sponsor
• Sen. Weicker, Lowell P., Jr. [R-CT] · R · Sponsor
• Sen. Stafford, Robert T. [R-VT] · R · Sponsor
• Sen. Denton, Jeremiah [R-AL] · R · Sponsor
• Sen. Sarbanes, Paul S. [D-MD] · D · Sponsor
• Sen. Wallop, Malcolm [R-WY] · R · Sponsor
• Sen. Metzenbaum, Howard M. [D-OH] · D · Sponsor
• Sen. Heinz, John [R-PA] · R · Sponsor
• Sen. Leahy, Patrick J. [D-VT] · D · Sponsor
• Sen. Inouye, Daniel K. [D-HI] · D · Sponsor
• Sen. Simon, Paul [D-IL] · D · Sponsor
• Sen. Cohen, William S. [R-ME] · R · Sponsor
• Sen. Thurmond, Strom [R-SC] · R · Sponsor
• Sen. Cranston, Alan [D-CA] · D · Sponsor
• Sen. Kerry, John F. [D-MA] · D · Sponsor
• Sen. Hawkins, Paula [R-FL] · R · Sponsor
• Sen. Roth Jr., William V. [R-DE] · R · Sponsor
• Sen. Riegle, Donald W., Jr. [D-MI] · D · Sponsor
• Sen. Nickles, Don [R-OK] · R · Sponsor
• Sen. Pell, Claiborne [D-RI] · D · Sponsor
• Sen. Matsunaga, Spark M. [D-HI] · D · Sponsor
• Sen. Durenberger, Dave [R-MN] · R · Cosponsor
• Sen. Grassley, Chuck [R-IA] · R · Cosponsor
• Sen. Mitchell, George J. [D-ME] · D · Cosponsor
• Sen. Andrews, Mark [R-ND] · R · Cosponsor
• Sen. Glenn, John H., Jr. [D-OH] · D · Cosponsor
• Sen. Levin, Carl [D-MI] · D · Cosponsor
• Sen. Gore, Albert, Jr. [D-TN] · D · Cosponsor
• Sen. Burdick, Quentin N. [D-ND] · D · Cosponsor
• Sen. Hollings, Ernest F. [D-SC] · D · Cosponsor

Related records

• related to → Orphan Drug Amendments of 1985
• amends ← To make technical and clarifying corrections.

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