Condemning recent hate crimes committed against Asian-American and Pacific Islanders.
- Last Action
- 4/28/2021
Actions
- 2021-03-04Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
- 2021-02-02Referred to the Subcommittee on Health.
- 2021-01-04Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2021-01-04Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2021-01-04Introduced in House
- 2021-01-04Introduced in House
CRS Summary
As of 2021-01-04 (00)
Protecting Consumer Access to Generic Drugs Act of 2021
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 shall 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.
Cosponsors (18)
- Sean Casten (D-IL)
- Steve Cohen (D-TN)
- Gerald Connolly (D-VA)
- Mark DeSaulnier (D-CA)
- Joe Neguse (D-CO)
- Raul Ruiz (D-CA)
- Lauren Underwood (D-IL)
- Jefferson Van Drew (R-NJ)
- David Scott (D-GA)
- Peter Welch (D-VT)
- JANICE SCHAKOWSKY (D-IL)
- David Trone (D-MD)
- Ro Khanna (D-CA)
- JOHN LARSON (D-CT)
- Lisa Blunt Rochester (D-DE)
- Ed Case (D-HI)
- ADAM SMITH (D-WA)
- Susan Wild (D-PA)
Subjects
- Administrative law and regulatory procedures
- Civil actions and liability
- Competition and antitrust
- Consumer affairs
- Drug safety, medical device, and laboratory regulation
- Federal Trade Commission (FTC)
- Intellectual property
- Judicial review and appeals
- Licensing and registrations
- Prescription drugs
Sourced from Congress.gov (public domain).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.