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2021-06-09
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-06-08
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
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Intro-H
2021-06-08
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2021-06-08
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Library of Congress
Introduced in House
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2021-06-08T14:01:15Z
Referred to
House
Energy and Commerce Committee
2021-06-09T18:12:32Z
Referred to
Health Subcommittee
hsif14
hsif00
Standing
Q000023
5
Mike
Rep. Quigley, Mike [D-IL-5]
Quigley
D
2021-06-08
IL
W000821
4
Bruce
Rep. Westerman, Bruce [R-AR-4]
Westerman
R
2021-06-08
AR
S001193
15
Eric
Rep. Swalwell, Eric [D-CA-15]
Swalwell
D
2021-06-08
CA
F000466
1
Brian
Rep. Fitzpatrick, Brian K. [R-PA-1]
Fitzpatrick
K.
R
2021-06-22
PA
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4
Jake
Rep. Auchincloss, Jake [D-MA-4]
Auchincloss
D
2021-07-28
MA
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4
Vicky
Rep. Hartzler, Vicky [R-MO-4]
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R
2021-08-17
MO
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Rep. McGovern, James P. [D-MA-2]
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D
2021-09-10
MA
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16
Anthony
Rep. Gonzalez, Anthony [R-OH-16]
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R
2021-10-22
OH
T000482
3
Lori
Rep. Trahan, Lori [D-MA-3]
Trahan
D
2021-11-04
MA
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.
2021-06-08
2021-06-09
Referred to the Subcommittee on Health.
House
Health
2021-05-13
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
CRS
Identical bill
Promising Pathway Act
S
2022-11-01
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
CRS
Related bill
Fair Care Act of 2022
HR
G000579
8
Mike
Rep. Gallagher, Mike [R-WI-8]
N
Gallagher
R
WI
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2021-06-08
Introduced in House
 <p><b>Promising Pathway Act</b></p> <p>This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable.</p> <p>The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations.</p> <p>During the COVID-19 (i.e., coronavirus disease 2019) pandemic, or another epidemic or pandemic, the FDA must accept and review various portions of a provisional approval application on a rolling basis.</p> <p>The manufacturer of a provisionally approved drug must require patients to participate in an observational registry. A manufacturer that fails to comply with registry requirements is subject to civil penalties.</p> <p>A provisionally approved drug must be labeled as such.</p> <p>If a drug that receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded.</p> <p>The bill also limits the liability of a manufacturer of a provisionally approved drug with respect to any claim under state law alleging that the drug is unsafe or ineffective.</p> <p>Private health insurers and federal health care programs shall not deny coverage of a provisionally approved drug on the basis of it being experimental.</p>
2021-07-27T14:31:09Z
00
2021-06-08T04:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr3761ih/xml/BILLS-117hr3761ih.xml
Promising Pathway Act
Promising Pathway Act
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Introduced in House
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Introduced in House
Promising Pathway Act
Short Title(s) as Introduced
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2022-12-30T17:32:54Z
2022-12-30T17:32:54Z
3.0.0
2021-05-13
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
CRS
Identical bill
Promising Pathway Act
S
2022-11-01
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
CRS
Related bill
Fair Care Act of 2022
HR
2021-06-09
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-06-08
Energy and Commerce Committee
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Referred to the House Committee on Energy and Commerce.
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2021-06-08
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2021-06-08
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D
2021-06-08
IL
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Rep. Westerman, Bruce [R-AR-4]
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2021-06-08
AR
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Eric
Rep. Swalwell, Eric [D-CA-15]
Swalwell
D
2021-06-08
CA
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2021-06-22
PA
A000148
4
Jake
Rep. Auchincloss, Jake [D-MA-4]
Auchincloss
D
2021-07-28
MA
H001053
4
Vicky
Rep. Hartzler, Vicky [R-MO-4]
Hartzler
R
2021-08-17
MO
M000312
2
JAMES
Rep. McGovern, James P. [D-MA-2]
MCGOVERN
P.
D
2021-09-10
MA
G000588
16
Anthony
Rep. Gonzalez, Anthony [R-OH-16]
Gonzalez
R
2021-10-22
OH
T000482
3
Lori
Rep. Trahan, Lori [D-MA-3]
Trahan
D
2021-11-04
MA
Cardiovascular and respiratory health Civil actions and liability Congressional oversight Drug safety, medical device, and laboratory regulation Drug therapy Emergency medical services and trauma care Employee benefits and pensions Government information and archives Government studies and investigations Health care costs and insurance Health care coverage and access Health information and medical records Immunology and vaccination Infectious and parasitic diseases Licensing and registrations Manufacturing Medical research Medical tests and diagnostic methods Prescription drugs Scientific communication
2021-06-08
Introduced in House
 <p><b>Promising Pathway Act</b></p> <p>This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable.</p> <p>The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations.</p> <p>During the COVID-19 (i.e., coronavirus disease 2019) pandemic, or another epidemic or pandemic, the FDA must accept and review various portions of a provisional approval application on a rolling basis.</p> <p>The manufacturer of a provisionally approved drug must require patients to participate in an observational registry. A manufacturer that fails to comply with registry requirements is subject to civil penalties.</p> <p>A provisionally approved drug must be labeled as such.</p> <p>If a drug that receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded.</p> <p>The bill also limits the liability of a manufacturer of a provisionally approved drug with respect to any claim under state law alleging that the drug is unsafe or ineffective.</p> <p>Private health insurers and federal health care programs shall not deny coverage of a provisionally approved drug on the basis of it being experimental.</p>
2021-07-27T14:31:09Z
00
Promising Pathway Act
Promising Pathway Act
Display Title
IH
Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act to establish a time-limited provisional approval pathway, subject to specific obligations, for certain drugs and biological products, and for other purposes.
Official Title as Introduced
IH
Introduced in House
Promising Pathway Act
Short Title(s) as Introduced
2021-06-09
Referred to the Subcommittee on Health.