US SB2019 | 2015-2016 | 114th Congress
Status
Spectrum: Bipartisan Bill
Status: Introduced on September 9 2015 - 25% progression, died in chamber
Action: 2015-09-22 - Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held.
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on September 9 2015 - 25% progression, died in chamber
Action: 2015-09-22 - Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held.
Text: Latest bill text (Introduced) [PDF]
Summary
Preserve Access to Affordable Generics Act This bill amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate a proceeding 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 Act if the filer of an 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, and (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 Act. 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 Act. 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.
Title
Preserve Access to Affordable Generics Act
Sponsors
Sen. Amy Klobuchar [D-MN] | Sen. Chuck Grassley [R-IA] |
History
Date | Chamber | Action |
---|---|---|
2015-09-22 | Senate | Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held. |
2015-09-09 | Senate | Read twice and referred to the Committee on the Judiciary. |
Subjects
Administrative law and regulatory procedures
Civil actions and liability
Commerce
Competition and antitrust
Contracts and agency
Federal Trade Commission (FTC)
Intellectual property
Judicial review and appeals
Marketing and advertising
Prescription drugs
Civil actions and liability
Commerce
Competition and antitrust
Contracts and agency
Federal Trade Commission (FTC)
Intellectual property
Judicial review and appeals
Marketing and advertising
Prescription drugs
US Congress State Sources
Type | Source |
---|---|
Summary | https://www.congress.gov/bill/114th-congress/senate-bill/2019/all-info |
Text | https://www.congress.gov/114/bills/s2019/BILLS-114s2019is.pdf |