Legis Daily

Fairness in Orphan Drug Exclusivity Act

USA117th CongressHR-1629| House 
| Updated: 5/20/2021
Madeleine Dean

Madeleine Dean

Democratic Representative

Pennsylvania

Cosponsors (2)
Marc A. Veasey (Democratic)Brian K. Fitzpatrick (Republican)

Health, Education, Labor, and Pensions Committee, Health Subcommittee, Energy and Commerce Committee, Budget Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.

Bill Text Versions

View Text
3 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 116-4712
Fairness in Orphan Drug Exclusivity Act
Feb 4, 2021

Latest Companion Bill Action

S 117-250
Introduced in Senate
Mar 8, 2021
Introduced in House
Mar 8, 2021
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.
Mar 9, 2021
Referred to the Subcommittee on Health.
May 11, 2021
Mr. Pallone moved to suspend the rules and pass the bill.
May 11, 2021
Considered under suspension of the rules. (consideration: CR H2181-2183; text: CR H2181-2182)
May 11, 2021
DEBATE - The House proceeded with forty minutes of debate on H.R. 1629.
May 11, 2021
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.
May 11, 2021
Considered as unfinished business. (consideration: CR H2184-2185)
May 11, 2021
On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).
View Vote
May 17, 2021
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.
May 19, 2021
Considered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)
May 19, 2021
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.
May 19, 2021
DEBATE - The House proceeded with one hour of debate on H.R. 1629.
May 19, 2021
The previous question was ordered pursuant to the rule.
May 19, 2021
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.
May 19, 2021
Considered as unfinished business. (consideration: CR H2572-2573)
May 19, 2021
On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150). (text: CR H2561)
View Vote
May 19, 2021
Motion to reconsider laid on the table Agreed to without objection.
May 20, 2021
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    HR 116-4712
    Fairness in Orphan Drug Exclusivity Act


  • February 4, 2021

    Latest Companion Bill Action

    S 117-250
    Introduced in Senate


  • March 8, 2021
    Introduced in House


  • March 8, 2021
    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.


  • March 9, 2021
    Referred to the Subcommittee on Health.


  • May 11, 2021
    Mr. Pallone moved to suspend the rules and pass the bill.


  • May 11, 2021
    Considered under suspension of the rules. (consideration: CR H2181-2183; text: CR H2181-2182)


  • May 11, 2021
    DEBATE - The House proceeded with forty minutes of debate on H.R. 1629.


  • May 11, 2021
    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.


  • May 11, 2021
    Considered as unfinished business. (consideration: CR H2184-2185)


  • May 11, 2021
    On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).
    View Vote


  • May 17, 2021
    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.


  • May 19, 2021
    Considered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)


  • May 19, 2021
    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.


  • May 19, 2021
    DEBATE - The House proceeded with one hour of debate on H.R. 1629.


  • May 19, 2021
    The previous question was ordered pursuant to the rule.


  • May 19, 2021
    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.


  • May 19, 2021
    Considered as unfinished business. (consideration: CR H2572-2573)


  • May 19, 2021
    On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150). (text: CR H2561)
    View Vote


  • May 19, 2021
    Motion to reconsider laid on the table Agreed to without objection.


  • May 20, 2021
    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • S 117-250: Fairness in Orphan Drug Exclusivity Act
  • HRES 117-403: Providing for consideration of the bill (H.R. 1629) to amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes; providing for consideration of the resolution (H. Res. 275) condemning the horrific shootings in Atlanta, Georgia, on March 16, 2021, and reaffirming the House of Representative's commitment to combating hate, bigotry, and violence against the Asian-American and Pacific Islander community; and for other purposes.
Competition and antitrustDrug safety, medical device, and laboratory regulationLicensing and registrationsMarketing and advertisingPrescription drugs

Fairness in Orphan Drug Exclusivity Act

USA117th CongressHR-1629| House 
| Updated: 5/20/2021
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.

Bill Text Versions

View Text
3 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 116-4712
Fairness in Orphan Drug Exclusivity Act
Feb 4, 2021

Latest Companion Bill Action

S 117-250
Introduced in Senate
Mar 8, 2021
Introduced in House
Mar 8, 2021
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.
Mar 9, 2021
Referred to the Subcommittee on Health.
May 11, 2021
Mr. Pallone moved to suspend the rules and pass the bill.
May 11, 2021
Considered under suspension of the rules. (consideration: CR H2181-2183; text: CR H2181-2182)
May 11, 2021
DEBATE - The House proceeded with forty minutes of debate on H.R. 1629.
May 11, 2021
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.
May 11, 2021
Considered as unfinished business. (consideration: CR H2184-2185)
May 11, 2021
On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).
View Vote
May 17, 2021
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.
May 19, 2021
Considered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)
May 19, 2021
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.
May 19, 2021
DEBATE - The House proceeded with one hour of debate on H.R. 1629.
May 19, 2021
The previous question was ordered pursuant to the rule.
May 19, 2021
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.
May 19, 2021
Considered as unfinished business. (consideration: CR H2572-2573)
May 19, 2021
On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150). (text: CR H2561)
View Vote
May 19, 2021
Motion to reconsider laid on the table Agreed to without objection.
May 20, 2021
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    HR 116-4712
    Fairness in Orphan Drug Exclusivity Act


  • February 4, 2021

    Latest Companion Bill Action

    S 117-250
    Introduced in Senate


  • March 8, 2021
    Introduced in House


  • March 8, 2021
    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.


  • March 9, 2021
    Referred to the Subcommittee on Health.


  • May 11, 2021
    Mr. Pallone moved to suspend the rules and pass the bill.


  • May 11, 2021
    Considered under suspension of the rules. (consideration: CR H2181-2183; text: CR H2181-2182)


  • May 11, 2021
    DEBATE - The House proceeded with forty minutes of debate on H.R. 1629.


  • May 11, 2021
    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.


  • May 11, 2021
    Considered as unfinished business. (consideration: CR H2184-2185)


  • May 11, 2021
    On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).
    View Vote


  • May 17, 2021
    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.


  • May 19, 2021
    Considered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)


  • May 19, 2021
    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.


  • May 19, 2021
    DEBATE - The House proceeded with one hour of debate on H.R. 1629.


  • May 19, 2021
    The previous question was ordered pursuant to the rule.


  • May 19, 2021
    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.


  • May 19, 2021
    Considered as unfinished business. (consideration: CR H2572-2573)


  • May 19, 2021
    On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150). (text: CR H2561)
    View Vote


  • May 19, 2021
    Motion to reconsider laid on the table Agreed to without objection.


  • May 20, 2021
    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Madeleine Dean

Madeleine Dean

Democratic Representative

Pennsylvania

Cosponsors (2)
Marc A. Veasey (Democratic)Brian K. Fitzpatrick (Republican)

Health, Education, Labor, and Pensions Committee, Health Subcommittee, Energy and Commerce Committee, Budget Committee

Health

Related Bills

  • S 117-250: Fairness in Orphan Drug Exclusivity Act
  • HRES 117-403: Providing for consideration of the bill (H.R. 1629) to amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes; providing for consideration of the resolution (H. Res. 275) condemning the horrific shootings in Atlanta, Georgia, on March 16, 2021, and reaffirming the House of Representative's commitment to combating hate, bigotry, and violence against the Asian-American and Pacific Islander community; and for other purposes.
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Competition and antitrustDrug safety, medical device, and laboratory regulationLicensing and registrationsMarketing and advertisingPrescription drugs