Legis Daily

Fairness in Orphan Drug Exclusivity Act

USA116th CongressHR-4712| House 
| Updated: 11/18/2020
Madeleine Dean

Madeleine Dean

Democratic Representative

Pennsylvania

Cosponsors (7)
Marc A. Veasey (Democratic)Darren Soto (Democratic)Van Taylor (Republican)Paul Tonko (Democratic)Earl L. "Buddy" Carter (Republican)David B. McKinley (Republican)Andy Kim (Democratic)

Health, Education, Labor, and Pensions Committee, Health Subcommittee, Energy and Commerce 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
4 versions available

Suggested Questions

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Timeline
Oct 17, 2019
Introduced in House
Oct 17, 2019
Referred to the House Committee on Energy and Commerce.
Oct 18, 2019
Referred to the Subcommittee on Health.
Feb 11, 2020

Latest Companion Bill Action

S 116-3271
Introduced in Senate
Mar 11, 2020
Subcommittee Consideration and Mark-up Session Held.
Mar 11, 2020
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Jul 15, 2020
Ordered to be Reported (Amended) by Voice Vote.
Jul 15, 2020
Committee Consideration and Mark-up Session Held.
Nov 16, 2020
Placed on the Union Calendar, Calendar No. 470.
Nov 16, 2020
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-572.
Nov 17, 2020
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Nov 17, 2020
Considered under suspension of the rules. (consideration: CR H5807-5809)
Nov 17, 2020
DEBATE - The House proceeded with forty minutes of debate on H.R. 4712.
Nov 17, 2020
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H5807)
Nov 17, 2020
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5807)
Nov 17, 2020
Motion to reconsider laid on the table Agreed to without objection.
Nov 18, 2020
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • October 17, 2019
    Introduced in House


  • October 17, 2019
    Referred to the House Committee on Energy and Commerce.


  • October 18, 2019
    Referred to the Subcommittee on Health.


  • February 11, 2020

    Latest Companion Bill Action

    S 116-3271
    Introduced in Senate


  • March 11, 2020
    Subcommittee Consideration and Mark-up Session Held.


  • March 11, 2020
    Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .


  • July 15, 2020
    Ordered to be Reported (Amended) by Voice Vote.


  • July 15, 2020
    Committee Consideration and Mark-up Session Held.


  • November 16, 2020
    Placed on the Union Calendar, Calendar No. 470.


  • November 16, 2020
    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-572.


  • November 17, 2020
    Mr. Pallone moved to suspend the rules and pass the bill, as amended.


  • November 17, 2020
    Considered under suspension of the rules. (consideration: CR H5807-5809)


  • November 17, 2020
    DEBATE - The House proceeded with forty minutes of debate on H.R. 4712.


  • November 17, 2020
    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H5807)


  • November 17, 2020
    On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5807)


  • November 17, 2020
    Motion to reconsider laid on the table Agreed to without objection.


  • November 18, 2020
    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • S 116-3271: Fairness in Orphan Drug Exclusivity Act
Competition and antitrustDrug safety, medical device, and laboratory regulationLicensing and registrationsMarketing and advertisingPrescription drugs

Fairness in Orphan Drug Exclusivity Act

USA116th CongressHR-4712| House 
| Updated: 11/18/2020
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
4 versions available

Suggested Questions

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

Timeline
Oct 17, 2019
Introduced in House
Oct 17, 2019
Referred to the House Committee on Energy and Commerce.
Oct 18, 2019
Referred to the Subcommittee on Health.
Feb 11, 2020

Latest Companion Bill Action

S 116-3271
Introduced in Senate
Mar 11, 2020
Subcommittee Consideration and Mark-up Session Held.
Mar 11, 2020
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Jul 15, 2020
Ordered to be Reported (Amended) by Voice Vote.
Jul 15, 2020
Committee Consideration and Mark-up Session Held.
Nov 16, 2020
Placed on the Union Calendar, Calendar No. 470.
Nov 16, 2020
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-572.
Nov 17, 2020
Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Nov 17, 2020
Considered under suspension of the rules. (consideration: CR H5807-5809)
Nov 17, 2020
DEBATE - The House proceeded with forty minutes of debate on H.R. 4712.
Nov 17, 2020
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H5807)
Nov 17, 2020
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5807)
Nov 17, 2020
Motion to reconsider laid on the table Agreed to without objection.
Nov 18, 2020
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • October 17, 2019
    Introduced in House


  • October 17, 2019
    Referred to the House Committee on Energy and Commerce.


  • October 18, 2019
    Referred to the Subcommittee on Health.


  • February 11, 2020

    Latest Companion Bill Action

    S 116-3271
    Introduced in Senate


  • March 11, 2020
    Subcommittee Consideration and Mark-up Session Held.


  • March 11, 2020
    Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .


  • July 15, 2020
    Ordered to be Reported (Amended) by Voice Vote.


  • July 15, 2020
    Committee Consideration and Mark-up Session Held.


  • November 16, 2020
    Placed on the Union Calendar, Calendar No. 470.


  • November 16, 2020
    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-572.


  • November 17, 2020
    Mr. Pallone moved to suspend the rules and pass the bill, as amended.


  • November 17, 2020
    Considered under suspension of the rules. (consideration: CR H5807-5809)


  • November 17, 2020
    DEBATE - The House proceeded with forty minutes of debate on H.R. 4712.


  • November 17, 2020
    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H5807)


  • November 17, 2020
    On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5807)


  • November 17, 2020
    Motion to reconsider laid on the table Agreed to without objection.


  • November 18, 2020
    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 (7)
Marc A. Veasey (Democratic)Darren Soto (Democratic)Van Taylor (Republican)Paul Tonko (Democratic)Earl L. "Buddy" Carter (Republican)David B. McKinley (Republican)Andy Kim (Democratic)

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

Health

Related Bills

  • S 116-3271: Fairness in Orphan Drug Exclusivity Act
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Competition and antitrustDrug safety, medical device, and laboratory regulationLicensing and registrationsMarketing and advertisingPrescription drugs