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  <updateDate>
   2023-03-08T20:11:47Z
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   117
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   &lt;pre&gt;[Congressional Record Volume 167, Number 43 (Monday, March 8, 2021)][House]From the Congressional Record Online through the Government Publishing Office [&lt;a href="https://www.gpo.gov"&gt;www.gpo.gov&lt;/a&gt;]By Ms. DEAN:H.R. 1629.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8[Page H1121]&lt;/pre&gt;
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     Fairness in Orphan Drug Exclusivity Act
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      Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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     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.
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      Motion to reconsider laid on the table Agreed to without objection.
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     Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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     Motion to reconsider laid on the table Agreed to without objection.
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     H38310
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    <actionDate>
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    <actionTime>
     14:55:21
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     On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150). (text: CR H2561)
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     Passed/agreed to in House: On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150).(text: CR H2561)
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    <actionDate>
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    <actionTime>
     14:23:22
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     Considered as unfinished business. (consideration: CR H2572-2573)
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     12:46:14
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     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.
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    <actionDate>
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    </actionDate>
    <actionTime>
     12:45:29
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     The previous question was ordered pursuant to the rule.
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     H35000
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     <code>
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     <name>
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   <item>
    <actionDate>
     2021-05-19
    </actionDate>
    <actionTime>
     12:32:49
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     DEBATE - The House proceeded with one hour of debate on H.R. 1629.
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     Floor
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     H8D000
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     <code>
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    <actionDate>
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    <actionTime>
     12:32:21
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     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.
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     <name>
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    <actionDate>
     2021-05-19
    </actionDate>
    <actionTime>
     12:32:16
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     Considered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)
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     Floor
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     <code>
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    <actionDate>
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     17:02:30
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     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.
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     H1L210
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   <item>
    <actionDate>
     2021-05-11
    </actionDate>
    <actionTime>
     19:08:53
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     On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).
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     Floor
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    <actionCode>
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     19:08:53
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     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).
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     18:30:21
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     Considered as unfinished business. (consideration: CR H2184-2185)
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     16:20:27
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     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.
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    <actionDate>
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     16:06:59
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     DEBATE - The House proceeded with forty minutes of debate on H.R. 1629.
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     16:06:56
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     Considered under suspension of the rules. (consideration: CR H2181-2183; text: CR H2181-2182)
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     16:06:26
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     Mr. Pallone moved to suspend the rules and pass the bill.
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     Referred to the Subcommittee on Health.
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     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.
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     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.
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      Licensing and registrations
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     Introduced in House
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     &lt;p&gt;&lt;b&gt;Fairness in Orphan Drug Exclusivity Act&lt;/b&gt;&lt;/p&gt; &lt;p&gt;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.)&lt;/p&gt; &lt;p&gt;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. &lt;/p&gt; &lt;p&gt;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.&lt;/p&gt;
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    <actionDesc>
     Passed House
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     2021-09-07T18:34:12Z
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     &lt;p&gt;&lt;b&gt;Fairness in Orphan Drug Exclusivity Act&lt;/b&gt;&lt;/p&gt; &lt;p&gt;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.)&lt;/p&gt; &lt;p&gt;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. &lt;/p&gt; &lt;p&gt;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.&lt;/p&gt;
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   Fairness in Orphan Drug Exclusivity Act
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   Congressional Research Service, Library of Congress
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   This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.
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2021-05-20
Health, Education, Labor, and Pensions Committee
sshr00
Senate
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
IntroReferral
H38310
2021-05-19
2
House floor actions
Motion to reconsider laid on the table Agreed to without objection.
Floor
H37100
2021-05-19
2
House floor actions
On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150). (text: CR H2561)
Floor
8000
2021-05-19
9
Library of Congress
Passed/agreed to in House: On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150).(text: CR H2561)
Floor
H30000
2021-05-19
2
House floor actions
Considered as unfinished business. (consideration: CR H2572-2573)
Floor
H8D000
2021-05-19
2
House floor actions
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.
Floor
H35000
2021-05-19
2
House floor actions
The previous question was ordered pursuant to the rule.
Floor
H8D000
2021-05-19
2
House floor actions
DEBATE - The House proceeded with one hour of debate on H.R. 1629.
Floor
H8D000
2021-05-19
2
House floor actions
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.
Floor
H30000
2021-05-19
2
House floor actions
Considered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)
Floor
H1L210
2021-05-17
2
House floor actions
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.
Floor
H37300
2021-05-11
2
House floor actions
On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).
Floor
9000
2021-05-11
9
Library of Congress
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).
Floor
H30000
2021-05-11
2
House floor actions
Considered as unfinished business. (consideration: CR H2184-2185)
Floor
H37220
2021-05-11
2
House floor actions
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.
Floor
H8D000
2021-05-11
2
House floor actions
DEBATE - The House proceeded with forty minutes of debate on H.R. 1629.
Floor
H30000
2021-05-11
2
House floor actions
Considered under suspension of the rules. (consideration: CR H2181-2183; text: CR H2181-2182)
Floor
H30300
2021-05-11
2
House floor actions
Mr. Pallone moved to suspend the rules and pass the bill.
Floor
2021-03-09
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-03-08
Budget Committee
hsbu00
2
House floor actions
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.
IntroReferral
H11100
2021-03-08
Energy and Commerce Committee
hsif00
2
House floor actions
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.
IntroReferral
Intro-H
2021-03-08
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-03-08
9
Library of Congress
Introduced in House
IntroReferral
2021-05-20T15:50:26Z
Referred to
Senate
Health, Education, Labor, and Pensions Committee
sshr00
Standing
2021-03-08T17:06:50Z
Referred to
House
Energy and Commerce Committee
2021-03-09T22:29:30Z
Referred to
Health Subcommittee
hsif14
hsif00
Standing
2021-03-08T17:07:00Z
Referred to
House
Budget Committee
hsbu00
Standing
V000131
33
Marc
Rep. Veasey, Marc A. [D-TX-33]
Veasey
A.
D
2021-03-08
TX
F000466
1
Brian
Rep. Fitzpatrick, Brian K. [R-PA-1]
Fitzpatrick
K.
R
2021-05-11
PA
Congressional Research Service, Library of Congress
This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
2021-03-08
2021-05-20
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
House
Health
2021-02-04
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
CRS
Related bill
Fairness in Orphan Drug Exclusivity Act
S
2021-05-18
Motion to reconsider laid on the table Agreed to without objection.
House
Related bill
House
Procedurally-related
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.
HRES
D000631
4
Madeleine
Rep. Dean, Madeleine [D-PA-4]
N
Dean
D
PA
Competition and antitrust Drug safety, medical device, and laboratory regulation Licensing and registrations Marketing and advertising Prescription drugs
2021-03-08
Introduced in House
 <p><b>Fairness in Orphan Drug Exclusivity Act</b></p> <p>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.)</p> <p>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. </p> <p>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.</p>
2021-09-07T18:34:54Z
00
2021-05-19
Passed House
 <p><b>Fairness in Orphan Drug Exclusivity Act</b></p> <p>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.)</p> <p>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. </p> <p>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.</p>
2021-09-07T18:34:12Z
53
2021-05-20T04:00:00Z
Referred in Senate
https://www.govinfo.gov/content/pkg/BILLS-117hr1629rfs/xml/BILLS-117hr1629rfs.xml
2021-05-19T04:00:00Z
Engrossed in House
https://www.govinfo.gov/content/pkg/BILLS-117hr1629eh/xml/BILLS-117hr1629eh.xml
2021-03-08T05:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr1629ih/xml/BILLS-117hr1629ih.xml
Fairness in Orphan Drug Exclusivity Act
Fairness in Orphan Drug Exclusivity Act
Display Title
IH
Introduced in House
Fairness in Orphan Drug Exclusivity Act
Short Title(s) as Introduced
EH
Engrossed in House
H
House
Fairness in Orphan Drug Exclusivity Act
Short Title(s) as Passed House
EH
Engrossed in House
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.
Official Title as Introduced
H
House
Fairness in Orphan Drug Exclusivity Act
Short Titles as Passed House
HR
2023-03-08T20:11:47Z
2023-03-08T20:11:47Z
3.0.0
2021-02-04
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
CRS
Related bill
Fairness in Orphan Drug Exclusivity Act
S
2021-05-18
Motion to reconsider laid on the table Agreed to without objection.
House
Related bill
House
Procedurally-related
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.
HRES
2021-05-20
Health, Education, Labor, and Pensions Committee
sshr00
Senate
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
IntroReferral
H38310
2021-05-19
2
House floor actions
Motion to reconsider laid on the table Agreed to without objection.
Floor
H37100
2021-05-19
2
House floor actions
On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150). (text: CR H2561)
Floor
8000
2021-05-19
9
Library of Congress
Passed/agreed to in House: On passage Passed by the Yeas and Nays: 402 - 23 (Roll no. 150).(text: CR H2561)
Floor
H30000
2021-05-19
2
House floor actions
Considered as unfinished business. (consideration: CR H2572-2573)
Floor
H8D000
2021-05-19
2
House floor actions
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.
Floor
H35000
2021-05-19
2
House floor actions
The previous question was ordered pursuant to the rule.
Floor
H8D000
2021-05-19
2
House floor actions
DEBATE - The House proceeded with one hour of debate on H.R. 1629.
Floor
H8D000
2021-05-19
2
House floor actions
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.
Floor
H30000
2021-05-19
2
House floor actions
Considered under the provisions of rule H. Res. 403. (consideration: CR H2560-2563)
Floor
H1L210
2021-05-17
2
House floor actions
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.
Floor
H37300
2021-05-11
2
House floor actions
On motion to suspend the rules and pass the bill Failed by the Yeas and Nays: (2/3 required): 250 - 168 (Roll no. 134).
Floor
9000
2021-05-11
9
Library of Congress
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).
Floor
H30000
2021-05-11
2
House floor actions
Considered as unfinished business. (consideration: CR H2184-2185)
Floor
H37220
2021-05-11
2
House floor actions
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.
Floor
H8D000
2021-05-11
2
House floor actions
DEBATE - The House proceeded with forty minutes of debate on H.R. 1629.
Floor
H30000
2021-05-11
2
House floor actions
Considered under suspension of the rules. (consideration: CR H2181-2183; text: CR H2181-2182)
Floor
H30300
2021-05-11
2
House floor actions
Mr. Pallone moved to suspend the rules and pass the bill.
Floor
2021-03-09
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-03-08
Budget Committee
hsbu00
2
House floor actions
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.
IntroReferral
H11100
2021-03-08
Energy and Commerce Committee
hsif00
2
House floor actions
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.
IntroReferral
Intro-H
2021-03-08
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-03-08
9
Library of Congress
Introduced in House
IntroReferral
D000631
4
Madeleine
Rep. Dean, Madeleine [D-PA-4]
N
Dean
D
PA
V000131
33
Marc
Rep. Veasey, Marc A. [D-TX-33]
Veasey
A.
D
2021-03-08
TX
F000466
1
Brian
Rep. Fitzpatrick, Brian K. [R-PA-1]
Fitzpatrick
K.
R
2021-05-11
PA
Competition and antitrust Drug safety, medical device, and laboratory regulation Licensing and registrations Marketing and advertising Prescription drugs
2021-03-08
Introduced in House
 <p><b>Fairness in Orphan Drug Exclusivity Act</b></p> <p>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.)</p> <p>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. </p> <p>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.</p>
2021-09-07T18:34:54Z
00
2021-05-19
Passed House
 <p><b>Fairness in Orphan Drug Exclusivity Act</b></p> <p>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.)</p> <p>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. </p> <p>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.</p>
2021-09-07T18:34:12Z
53
Fairness in Orphan Drug Exclusivity Act
Fairness in Orphan Drug Exclusivity Act
Display Title
IH
Introduced in House
Fairness in Orphan Drug Exclusivity Act
Short Title(s) as Introduced
EH
Engrossed in House
H
House
Fairness in Orphan Drug Exclusivity Act
Short Title(s) as Passed House
EH
Engrossed in House
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.
Official Title as Introduced
H
House
Fairness in Orphan Drug Exclusivity Act
Short Titles as Passed House
2021-05-20
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.