Preserve Access to Affordable Generics and Biosimilars Act

Summary

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 and secure final approval for 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.

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Timeline

1. 30 January 2023

   Introduced

   Read twice and referred to the Committee on the Judiciary.

   Source: IntroReferral

2. 30 January 2023

   Introduced

   Introduced in Senate

   Source: IntroReferral

3. 9 February 2023

   Reported

   Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.

   Source: Committee

4. 1 March 2023

   Reported

   Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.

   Source: Committee

5. 1 March 2023

   Calendars

   Placed on Senate Legislative Calendar under General Orders. Calendar No. 20.

   Source: Calendars

6. 1 March 2023

   Reported

   Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Reported to Senate · 1 March 2023 · Official file
• Introduced in Senate · 30 January 2023 · Official file

Documents

6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 1 March 2023

  ViewDownloadOpen at official source

• Reported to Senate (PDF)

  Reported to Senate · EN · 1 March 2023

  ViewDownloadOpen at official source

• Reported to Senate

  summary · EN · 1 March 2023

  Open at official source

• Introduced in Senate (text)

  Introduced in Senate · EN · 30 January 2023

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 30 January 2023

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 30 January 2023

  Open at official source

Sponsors

• Amy Klobuchar · D · Sponsor
• Chuck Grassley · R · Sponsor
• Richard Durbin · D · Sponsor
• Kevin Cramer · R · Sponsor
• Richard Blumenthal · D · Sponsor
• Mark Kelly · D · Sponsor
• Chris Van Hollen · D · Sponsor
• Sen. Booker, Cory A. [D-NJ] · D · Sponsor
• Jon Ossoff · D · Cosponsor
• Joni Ernst · R · Cosponsor
• Peter Welch · D · Cosponsor
• · ssju00 · Standing

Related records

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