Protecting Consumer Access to Generic Drugs Act of 2019
Latest action · May 10, 2019 Placed on the Union Calendar, Calendar No. 30.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMar 5, 2019
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
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.
Cosponsors 38
Members who signed on, in the order they did. Signatures ran from Mar 26, 2019 to May 9, 2019.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-MN | Angie Craig | Mar 26, 2019 | |
| D-CA | Anna G. Eshoo | Mar 26, 2019 | |
| D-MI | Debbie Dingell | Mar 26, 2019 | |
| D-NJ | Frank Pallone, Jr. | Mar 26, 2019 | |
| D-MA | Joseph P. Kennedy III | Mar 26, 2019 | |
| D-CA | Raul Ruiz | Mar 26, 2019 | |
| D-CA | Doris O. Matsui | Mar 27, 2019 | |
| R-NJ | Jefferson Van Drew | Apr 1, 2019 | |
| D-NY | Yvette D. Clarke | Apr 1, 2019 | |
| D-CA | Ro Khanna | Apr 3, 2019 | |
| D-NH | Chris Pappas | Apr 4, 2019 | |
| D-IL | Janice D. Schakowsky | Apr 4, 2019 | |
| D-VT | Peter Welch | Apr 8, 2019 | |
| D-TN | Steve Cohen | Apr 8, 2019 | |
| D-FL | Alcee L. Hastings | Apr 9, 2019 |
Actions 11
Everything that happened, newest first.
- May 10, 2019Committee on the Judiciary discharged.
- May 10, 2019Placed on the Union Calendar, Calendar No. 30.
- May 10, 2019Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-52, Part I.
- Apr 8, 2019Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
- Apr 3, 2019Committee Consideration and Mark-up Session Held.
Related bills 3
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 19 | Lower Costs, More Cures Act of 2019 | Related bill | Dec 19, 2019 |
| HR 987 | Strengthening Health Care and Lowering Prescription Drug Costs Act | Related bill | May 20, 2019 |
| HR 2700 | Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act | Related bill | Jun 26, 2019 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
- 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)
- Health
- Intellectual property
- Judicial review and appeals
- Licensing and registrations
- Prescription drugs
Text 2
Each version as it was printed, newest first.
- May 10, 2019Reported in House
- Mar 5, 2019Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.