PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Congressional Research Service
Version 00 · Introduced in House · May 14, 2019
Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act
This bill addresses prescription drugs and extends several health care, research, and workforce programs.
Currently, a generic drug manufacturer is awarded 180 days of exclusivity on the market if it is the first applicant to file an application with the Food and Drug Administration (FDA), and the exclusivity period begins upon the first applicant's commercial marketing. The bill authorizes the FDA to approve a subsequent generic drug application prior to the first applicant's first date of commercial marketing if certain conditions are met.
Showing the opening paragraphs of the official summary.
The bill prohibits a brand-name, generic, or biosimilar drug manufacturer from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement, with specified exclusions, is a violation of the bill if the filer of the subsequent generic application receives something of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biological product.
The developer of a drug or biological product, such as a generic or biosimilar version of a drug, may bring a civil action against the license holder of an approved drug if the holder has declined to make available sufficient quantities of the approved drug for the developer's testing.
The bill also extends several health care, research, and workforce programs, including the National Health Service Corps, through FY2020.
People & committees
Rep. Burgess, Michael C. [R-TX-26] · R–TX
Legislative record
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Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Referred to the Subcommittee on Health.
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.
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.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Jan 16, 2025. Consult Congress.gov for the current record.
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