Protecting Consumer Access to Generic Drugs Act of 2019

openUnited States· United States Congress· EN

Introduced

5 March 2019

Last action

10 May 2019 · Reported

Status

Placed on the Union Calendar, Calendar No. 30.

Summary

Protecting Consumer Access to Generic Drugs Act of 2019 This bill prohibits the manufacturer of a brand-name, generic, or biosimilar drug from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product. Specifically, such an agreement shall, with some exceptions, be a violation of the bill if the filer of a subsequent application to market a drug or biological product receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the subsequent drug or biological product. (Typically, a subsequent application seeks to market a generic or biosimilar version of a patented drug or biological product.) Penalties for violations of the bill include civil penalties and loss of the 180-day exclusivity period for a generic drug. The Federal Trade Commission (FTC) shall have exclusive authority to litigate to enforce the bill. When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains (1) the complete agreement; and (2) any agreements related to the main agreement, including descriptions of any oral agreements or representations.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

5 March 2019
Introduced
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, 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.
Source: IntroReferral
5 March 2019
Introduced
Introduced in House
Source: IntroReferral
5 March 2019
Introduced
Introduced in House
Source: IntroReferral
6 March 2019
Referred
Referred to the Subcommittee on Health.
Source: Committee
27 March 2019
Committee
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Source: Committee
27 March 2019
Committee
Subcommittee Consideration and Mark-up Session Held.
Source: Committee
3 April 2019
Reported
Ordered to be Reported (Amended) by Voice Vote.
Source: Committee
3 April 2019
Committee
Committee Consideration and Mark-up Session Held.
Source: Committee
8 April 2019
Referred
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Source: Committee
10 May 2019
Calendars
Placed on the Union Calendar, Calendar No. 30.
Source: Calendars
10 May 2019
Discharge
Committee on the Judiciary discharged.
Source: Discharge
10 May 2019
Committee
Committee on the Judiciary discharged.
Source: Committee
10 May 2019
Reported
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-52, Part I.
Source: Committee
10 May 2019
Reported
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-52, Part I.
Source: Committee

Votes

No vote records are attached yet.

Versions

Reported in House · 10 May 2019 · Download file
Introduced in House · 5 March 2019 · Download file

Documents

6 official files

Reported in House (text)

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Reported in House (text)
Reported in House · EN · 10 May 2019
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Reported in House (PDF)
Reported in House · EN · 10 May 2019
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Reported to House, Part I
summary · EN · 10 May 2019
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Introduced in House (text)
Introduced in House · EN · 5 March 2019
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Introduced in House (PDF)
Introduced in House · EN · 5 March 2019
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Introduced in House
summary · EN · 5 March 2019
Open at official source
Leesvertaling
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Related records

related to → Lower Costs, More Cures Act of 2019
related to → Strengthening Health Care and Lowering Prescription Drug Costs Act
related to ← Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act

Sources

PoliticalRepo is an index and interpretation layer, not the authoritative legal source.

Official source: https://www.congress.gov/bill/116th-congress/house-bill/1499
Open data entity: https://api.congress.gov/v3/bill/116/hr/1499
us · 116-hr-1499 · source updated 7 April 2025