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A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.

USA115th CongressS-124| Senate 
| Updated: 1/12/2017
Amy Klobuchar

Amy Klobuchar

Democratic Senator

Minnesota

Cosponsors (1)
Chuck Grassley (Republican)

Judiciary Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
Jan 12, 2017
Introduced in Senate
Jan 12, 2017
Read twice and referred to the Committee on the Judiciary.
Oct 27, 2017

Latest Companion Bill Action

HR 115-4117
Referred to the Subcommittee on Digital Commerce and Consumer Protection.
  • January 12, 2017
    Introduced in Senate


  • January 12, 2017
    Read twice and referred to the Committee on the Judiciary.


  • October 27, 2017

    Latest Companion Bill Action

    HR 115-4117
    Referred to the Subcommittee on Digital Commerce and Consumer Protection.

Health

Related Bills

  • S 115-3792: 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 manufactures from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products.
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustContracts and agencyFederal Trade Commission (FTC)Intellectual propertyJudicial review and appealsMarketing and advertisingPrescription drugs

A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.

USA115th CongressS-124| Senate 
| Updated: 1/12/2017
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jan 12, 2017
Introduced in Senate
Jan 12, 2017
Read twice and referred to the Committee on the Judiciary.
Oct 27, 2017

Latest Companion Bill Action

HR 115-4117
Referred to the Subcommittee on Digital Commerce and Consumer Protection.
  • January 12, 2017
    Introduced in Senate


  • January 12, 2017
    Read twice and referred to the Committee on the Judiciary.


  • October 27, 2017

    Latest Companion Bill Action

    HR 115-4117
    Referred to the Subcommittee on Digital Commerce and Consumer Protection.
Amy Klobuchar

Amy Klobuchar

Democratic Senator

Minnesota

Cosponsors (1)
Chuck Grassley (Republican)

Judiciary Committee

Health

Related Bills

  • S 115-3792: 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 manufactures from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products.
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresCivil actions and liabilityCompetition and antitrustContracts and agencyFederal Trade Commission (FTC)Intellectual propertyJudicial review and appealsMarketing and advertisingPrescription drugs