3.0.0 64 2022-11-01T13:49:22Z 2022-11-01T14:23:22Z Senate S 2019-01-09 116 ssju00 Judiciary Committee Senate Standing Referred to 2019-01-09T18:14:50Z Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020 116 3384 S 2020-03-03 Read twice and referred to the Committee on Finance. Related bill CRS Affordable Medications Act 116 1801 S 2019-06-12 Read twice and referred to the Committee on Finance. Related bill CRS Competitive DRUGS Act of 2019 116 1344 HR 2019-03-25 Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Related bill CRS Preserve Access to Affordable Generics and Biosimilars Act 116 2375 HR 2020-12-24 Placed on the Union Calendar, Calendar No. 576. Related bill CRS 2019-01-09 ssju00 Judiciary Committee Senate Read twice and referred to the Committee on the Judiciary. IntroReferral 2019-01-09 Introduced in Senate IntroReferral 10000 9 Library of Congress K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN N G000386 Sen. Grassley, Chuck [R-IA] Charles Grassley R IA E. 2019-01-09 True L000174 Sen. Leahy, Patrick J. [D-VT] Patrick Leahy D VT 2019-01-28 False E000295 Sen. Ernst, Joni [R-IA] Joni Ernst R IA 2019-01-28 False C001096 Sen. Cramer, Kevin [R-ND] Kevin Cramer R ND 2019-03-28 False D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2019-04-10 False V000128 Sen. Van Hollen, Chris [D-MD] Chris Van Hollen D MD 2019-06-05 False C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2019-06-05 False Health Administrative law and regulatory procedures Civil actions and liability Competition and antitrust Contracts and agency Federal Trade Commission (FTC) Intellectual property Judicial review and appeals Licensing and registrations Manufacturing Marketing and advertising Prescription drugs Health 00 2019-01-09 Introduced in Senate 2020-05-08T11:51:21Z Preserve Access to Affordable Generics and Biosimilars Act

This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.

An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.

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 the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations.

The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

]]> Preserve Access to Affordable Generics and Biosimilars Act Display Title Preserve Access to Affordable Generics and Biosimilars Act Short Title(s) as Introduced Preserve Access to Affordable Generics and Biosimilars Act Introduced in Senate IS Official Title as Introduced A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. Introduced in Senate IS Introduced in Senate 2019-01-09T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s64is/xml/BILLS-116s64is.xml 2019-01-09 Read twice and referred to the Committee on the Judiciary. 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. 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.