Protecting Consumer Access to Generic Drugs Act of 2019

Bill: 116-hr-1499
Sponsor: Rep. Rush, Bobby L. [D-IL-1]
Introduced: 2019-03-05 in the House
Policy area: Health
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

Summary:
action_date: 2019-03-05
text: 

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.

action_date: 2019-05-10
text: 

Protecting Consumer Access to Generic Drugs Act of 20

19

 
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.


Legislative actions:
action_date: 2019-05-10
text: Placed on the Union Calendar, Calendar No. 30.
action_date: 2019-05-10
text: Committee on the Judiciary discharged.
action_date: 2019-05-10
text: Committee on the Judiciary discharged.
action_date: 2019-05-10
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-52, Part I.
action_date: 2019-05-10
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-52, Part I.
action_date: 2019-04-08
text: Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
action_date: 2019-04-03
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2019-04-03
text: Committee Consideration and Mark-up Session Held.
action_date: 2019-03-27
text: Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
action_date: 2019-03-27
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2019-03-06
text: Referred to the Subcommittee on Health.
action_date: 2019-03-05
text: Referred 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.
action_date: 2019-03-05
text: Referred 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.
action_date: 2019-03-05
text: Introduced in House
action_date: 2019-03-05
text: Introduced in House