3.0.0 124 2023-01-11T13:34:08Z 2023-01-11T13:34:08Z Senate S 2017-01-12 115 ssju00 Judiciary Committee Senate Standing Referred to 2017-01-12T19:46:41Z Preserve Access to Affordable Generics and Biosimilars Act 115 3792 S 2018-12-19 Read twice and referred to the Committee on the Judiciary. Related bill CRS 2017-01-12 ssju00 Judiciary Committee Senate Read twice and referred to the Committee on the Judiciary. IntroReferral 2017-01-12 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. 2017-01-12 True 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 Marketing and advertising Prescription drugs Health 00 2017-01-12 Introduced in Senate 2017-02-01T17:14:51Z Preserve Access to Affordable Generics Act

This bill amends the Federal Trade Commission Act to authorize 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. Such an agreement, with specified exceptions, is presumed to have anticompetitive effects and is a violation of this bill if the filer of the abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug.

An agreement is exempted if the only consideration granted to the generic manufacturer is: (1) the right to market the generic drug 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 infringes a patent.

An entity subject to an FTC enforcement order may petition for the order be reviewed in federal court. Civil penalties are imposed for violations of this bill.

This bill amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, sale, or exclusivity period of a drug.

This bill amends the Federal Food, Drug, and Cosmetic Act to forfeit the 180-day exclusivity period for a generic drug if the FTC or a court decides that an agreement violated this bill.

The FTC is granted exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic drugs. The FTC may not commence enforcement actions (other than cease and desist requests) more than six years after the FTC is notified of an agreement.

]]> Preserve Access to Affordable Generics Act Display Title Preserve Access to Affordable Generics Act 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. Introduced in Senate IS Short Titles as Introduced Preserve Access to Affordable Generics Act Introduced in Senate 2017-01-12T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115s124is/xml/BILLS-115s124is.xml 2017-01-12 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.