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Bill117th CongressFiled Mar 8, 2021Health
H.R. 1629

Fairness in Orphan Drug Exclusivity Act

Bill journey · stage 2 of 5

Under committee review

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Law

What it doesSummary passed house (May 19, 2021)

Fairness in Orphan Drug Exclusivity Act

This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats. The sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.)

Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment.

When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.

What just happenedMay 20, 2021

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Who’s behind it

Rep. Dean, Madeleine [D-PA-4](D-PA)Sponsor
2 cosponsors1 D1 R
Read on Congress.gov
2cosponsors3committees23actions2related bills5subjects
  1. May 20, 2021IntroReferral

    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

    Health, Education, Labor, and Pensions Committee
  2. May 19, 2021FloorH38310

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

  3. May 19, 2021FloorH37100

    On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150). (text: CR H2561)

  4. May 19, 2021Floor8000

    Passed/agreed to in House: On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150).(text: CR H2561)

  5. May 19, 2021FloorH30000

    Considered as unfinished business. (consideration: CR H2572-2573)

  6. May 19, 2021FloorH8D000

    POSTPONED PROCEEDINGS - At the conclusion of debate on H.R. 1629, the Chair put the question on passage and by voice vote, announced that the ayes had prevailed. Mrs. Greene (GA) demanded the yeas and nays and the Chair postponed further proceedings on the question of passage until a time to be announced.

  7. May 19, 2021FloorH35000

    The previous question was ordered pursuant to the rule.

  8. May 19, 2021FloorH8D000

    DEBATE - The House proceeded with one hour of debate on H.R. 1629.

  9. May 19, 2021FloorH8D000

    Rule provides for consideration of H.R. 1629 and H. Res. 275. The resolution provides for consideration of H.R. 1629 under a closed rule and H. Res. 275 under a closed rule. The resolution provides for one hour of debate on both the bill and resolution. The rule provides that H. Res. 398 is hereby adopted. The rule provides at any time through the legislative day of Thursday, May 20, 2021, the Speaker may entertain motions offered by the Majority Leader or designee with respect to multiple measures that were object of motions to suspend the rules on the legislative days of May 17 or 18, 2021.

  10. May 19, 2021FloorH30000

    Considered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)

  11. May 17, 2021FloorH1L210

    Rules Committee Resolution H. Res. 403 Reported to House. Rule provides for consideration of H.R. 1629 and H. Res. 275. The resolution provides for consideration of H.R. 1629 under a closed rule and H. Res. 275 under a closed rule. The resolution provides for one hour of debate on both the bill and resolution. The rule provides that H. Res. 398 is hereby adopted. The rule provides at any time through the legislative day of Thursday, May 20, 2021, the Speaker may entertain motions offered by the Majority Leader or designee with respect to multiple measures that were object of motions to suspend the rules on the legislative days of May 17 or 18, 2021.

  12. May 11, 2021FloorH37300

    On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).

  13. May 11, 2021Floor9000

    Failed of passage/not agreed to in House: On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).

  14. May 11, 2021FloorH30000

    Considered as unfinished business. (consideration: CR H2184-2185)

  15. May 11, 2021FloorH37220

    At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.

  16. May 11, 2021FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate on H.R. 1629.

  17. May 11, 2021FloorH30000

    Considered under suspension of the rules. (consideration: CR H2181-2183; text: CR H2181-2182)

  18. May 11, 2021FloorH30300

    Mr. Pallone moved to suspend the rules and pass the bill.

  19. Mar 9, 2021Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  20. Mar 8, 2021IntroReferralH11100

    Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

    Budget Committee
  21. Mar 8, 2021IntroReferralH11100

    Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

    Energy and Commerce Committee
  22. Mar 8, 2021IntroReferralIntro-H

    Introduced in House

  23. Mar 8, 2021IntroReferral1000

    Introduced in House

Passed HouseMay 19, 202153

Fairness in Orphan Drug Exclusivity Act

This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats. The sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.)

Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment.

When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.

Introduced in HouseMar 8, 2021

Fairness in Orphan Drug Exclusivity Act

This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats. The sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.)

Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment.

When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.

Fairness in Orphan Drug Exclusivity Act — Informed