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Bill101th CongressFiled Apr 26, 1990Health
H.R. 4638

Orphan Drug Amendments of 1990

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What it doesSummary passed senate amended (Oct 12, 1990)

Orphan Drug Amendments of 1990 - Amends provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) relating to designation of drugs for rare diseases or conditions to require that the number of people affected be determined three years after the request for designation as well as on the date of the request.

Creates additional exceptions from the protection of exclusive approval, certification, or license for drugs for rare diseases for: (1) drugs which qualified for protection because the disease or condition for which they are used affected less than a specified number of persons, but which have ceased to so qualify; and (2) drugs which were developed simultaneously.

Requires that designation of a drug be published in the Federal Register and otherwise made available to the public in a manner designed to notify persons who have the disease or condition involved.

Directs the Secretary of Health and Human Services to request the Institute of Medicine of the National Academy of Sciences to enter into a contract to study the effect caused by this Act on the development of drugs for rare diseases or conditions. Declares that, if the Institute declines to conduct such study, the Secretary shall conduct the study through another public or nonprofit entity.

Amends the Public Health Service Act to replace provisions establishing the Orphan Products Board with provisions establishing under the Assistant Secretary for Health the Office for Orphan Diseases and Conditions. Expands the functions of the Office (previously the Board) to include medical foods as well as drugs and devices. Establishes an advisory committee to advise the Office.

Amends the FDCA to authorize appropriations for FY 1991 through 1993 for grants and contracts, under provisions for development of drugs for rare diseases and conditions.

What just happenedNov 10, 1990

Pocket Vetoed by President.

Who’s behind it

Rep. Waxman, Henry A. [D-CA-24](D-CA)Sponsor
Read on Congress.gov
2committees38actions1amendments1related bills11subjects
  1. Nov 10, 1990PresidentE30000

    Pocket Vetoed by President.

  2. Nov 10, 1990President30000

    Pocket Vetoed by President.

  3. Oct 30, 1990FloorE20000

    Presented to President.

  4. Oct 30, 1990President28000

    Presented to President.

  5. Oct 26, 1990Floor

    Measure Signed in Senate.

  6. Oct 23, 1990ResolvingDifferencesH41931

    Motion to reconsider laid on the table Agreed to without objection.

  7. Oct 23, 1990ResolvingDifferencesH41610

    On motion that the House agree to the Senate amendment Agreed to by voice vote.

  8. Oct 23, 1990NotUsed19500

    Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to by voice vote.

  9. Oct 23, 1990FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate.

  10. Oct 23, 1990ResolvingDifferencesH41220

    Mr. Bliley demanded a second on the motion to suspend the rules. Without objection a second was ordered.

  11. Oct 23, 1990ResolvingDifferencesH40400

    Mr. Waxman moved that the House suspend the rules and agree to the Senate amendment.

  12. Oct 16, 1990Floor

    Message on Senate action sent to the House.

  13. Oct 12, 1990Floor

    Passed Senate with an amendment by Voice Vote.

  14. Oct 12, 1990Floor17000

    Passed/agreed to in Senate: Passed Senate with an amendment by Voice Vote.

  15. Oct 12, 1990Floor

    Amendment SP 2977 agreed to in Senate by Voice Vote.

  16. Oct 12, 1990Floor

    Amendment SP 2977 proposed by Senator Armstrong for Senator Hatch.

  17. Oct 12, 1990Discharge

    Senate Committee on Labor and Human Resources discharged by Unanimous Consent.

    Health, Education, Labor, and Pensions Committee
  18. Oct 12, 1990Committee14500

    Senate Committee on Labor and Human Resources discharged by Unanimous Consent.

    Health, Education, Labor, and Pensions Committee
  19. Jul 31, 1990IntroReferral

    Received in the Senate and read twice and referred to the Committee on Labor and Human Resources.

    Health, Education, Labor, and Pensions Committee
  20. Jul 30, 1990FloorH38310

    Motion to reconsider laid on the table Agreed to without objection.

  21. Jul 30, 1990FloorH37300

    On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.

  22. Jul 30, 1990Floor8000

    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.

  23. Jul 30, 1990FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate.

  24. Jul 30, 1990FloorH30321

    On ordering a second Agreed to without objection.

  25. Jul 30, 1990FloorH30000

    Considered under suspension of the rules.

  26. Jul 30, 1990FloorH30320

    Mr. Nielson demanded a second on the motion to suspend the rules.

  27. Jul 30, 1990FloorH30300

    Mr. Waxman moved to suspend the rules and pass the bill, as amended.

  28. Jul 27, 1990CalendarsH12410

    Placed on the Union Calendar, Calendar No. 394.

  29. Jul 27, 1990CommitteeH12200

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 101-635.

    Energy and Commerce Committee
  30. Jul 27, 1990Committee5000

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 101-635.

    Energy and Commerce Committee
  31. Jul 17, 1990CommitteeH15000-B

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  32. Jul 17, 1990CommitteeH19000

    Ordered to be Reported (Amended).

    Energy and Commerce Committee
  33. Jun 21, 1990CommitteeH22000

    Subcommittee Consideration and Mark-up Session Held.

    Health and Environment Subcommittee
  34. Jun 21, 1990CommitteeH23000

    Forwarded by Subcommittee to Full Committee (Amended).

    Health and Environment Subcommittee
  35. May 4, 1990CommitteeH11000

    Referred to the Subcommittee on Health and the Environment.

    Health and Environment Subcommittee
  36. Apr 26, 1990IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  37. Apr 26, 1990IntroReferralIntro-H

    Introduced in House

  38. Apr 26, 1990IntroReferral1000

    Introduced in House

Passed Senate amendedOct 12, 199035

Orphan Drug Amendments of 1990 - Amends provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) relating to designation of drugs for rare diseases or conditions to require that the number of people affected be determined three years after the request for designation as well as on the date of the request.

Creates additional exceptions from the protection of exclusive approval, certification, or license for drugs for rare diseases for: (1) drugs which qualified for protection because the disease or condition for which they are used affected less than a specified number of persons, but which have ceased to so qualify; and (2) drugs which were developed simultaneously.

Requires that designation of a drug be published in the Federal Register and otherwise made available to the public in a manner designed to notify persons who have the disease or condition involved.

Directs the Secretary of Health and Human Services to request the Institute of Medicine of the National Academy of Sciences to enter into a contract to study the effect caused by this Act on the development of drugs for rare diseases or conditions. Declares that, if the Institute declines to conduct such study, the Secretary shall conduct the study through another public or nonprofit entity.

Amends the Public Health Service Act to replace provisions establishing the Orphan Products Board with provisions establishing under the Assistant Secretary for Health the Office for Orphan Diseases and Conditions. Expands the functions of the Office (previously the Board) to include medical foods as well as drugs and devices. Establishes an advisory committee to advise the Office.

Amends the FDCA to authorize appropriations for FY 1991 through 1993 for grants and contracts, under provisions for development of drugs for rare diseases and conditions.

Passed House amendedJul 30, 199036

Orphan Drug Amendments of 1990 - Amends provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) relating to designation of drugs for rare diseases or conditions to require that the number of people affected be determined three years after the request for designation as well as on the date of the request.

Creates additional exceptions from the protection of exclusive approval, certification, or license for drugs for rare diseases for: (1) drugs which qualified for protection because the disease or condition for which they are used affected less than a specified number of persons, but which have ceased to so qualify; and (2) drugs which were developed simultaneously.

Requires that designation of a drug be published in the Federal Register and otherwise made available to the public in a manner designed to notify persons who have the disease or condition involved.

Directs the Secretary of Health and Human Services to request the Institute of Medicine of the National Academy of Sciences to enter into a contract to study the effect caused by this Act on the +evelopment of drugs for rare diseases or conditions. Declares that, if the Institute declines to conduct such study, the Secretary shall conduct the study through another public or nonprofit entity.

Amends the Public Health Service Act to replace provisions establishing the Orphan Products Board with provisions establishing under the Assistant Secretary for Health the Office for Orphan Diseases and Conditions. Expands the functions of the Office (previously the Board) to include medical foods as well as drugs and devices. Establishes an advisory committee to advise the Office.

Amends the FDCA to authorize appropriations for FY 1991 through 1993 for grants and contracts, under provisions for development of drugs for rare diseases and conditions.

Introduced in HouseApr 26, 199000

Orphan Drug Amendments of 1990 - Amends provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) relating to designation of drugs for rare diseases or conditions to require that the number of people affected be determined three years after the request for designation as well as on the date of the request.

Creates additional exceptions from the protection of exclusive approval, certification, or license for drugs for rare diseases for: (1) drugs which qualified for protection because the disease or condition for which they are used affected less than a specified number of persons, but which have ceased to so qualify; and (2) drugs which were developed simultaneously.

Requires that designation of a drug be published in the Federal Register and otherwise made available to the public in a manner designed to notify persons who have the disease or condition involved.

Amends the Public Health Service Act to replace provisions establishing the Orphan Products Board with provisions establishing under the Assistant Secretary for Health the Office for Orphan Diseases and Conditions. Expands the functions of the Office (previously the Board) to include medical foods as well as drugs and devices. Establishes an advisory committee to advise the Office.

Amends the FDCA to authorize appropriations for grants and contracts, under provisions for development of drugs for rare diseases and conditions.

Orphan Drug Amendments of 1990 — Informed