Protecting Consumer Access to Generic Drugs Act of 2019

Summary

Protecting Consumer Access to Generic Drugs Act of 2019 This bill prohibits the manufacturer of a brand-name, generic, or biosimilar drug from entering into certain agreements to resolve or settle a patent infringement claim in connection with the sale of a drug or biological product. Specifically, such an agreement shall, with some exceptions, be a violation of the bill if the filer of a subsequent application to market a drug or biological product receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the subsequent drug or biological product. (Typically, a subsequent application seeks to market a generic or biosimilar version of a patented drug or biological product.) Penalties for violations of the bill include civil penalties and loss of the 180-day exclusivity period for a generic drug. The Federal Trade Commission (FTC) shall have exclusive authority to litigate to enforce the bill. 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 (1) the complete agreement; and (2) any agreements related to the main agreement, including descriptions of any oral agreements or representations.

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Documents

6 official files

• Reported in House (text)

  Reported in House · EN · 10 May 2019

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• Reported in House (PDF)

  Reported in House · EN · 10 May 2019

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• Reported to House, Part I

  summary · EN · 10 May 2019

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• Introduced in House (text)

  Introduced in House · EN · 5 March 2019

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• Introduced in House (PDF)

  Introduced in House · EN · 5 March 2019

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• Introduced in House

  summary · EN · 5 March 2019

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