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 | |
| D-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 |
Committees 2
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Mar 5, 2019Markup Apr 3, 2019Reported May 10, 2019 |
| Health Subcommittee | Referred Mar 6, 2019Markup Mar 27, 2019Reported Mar 27, 2019 | |
| House | Judiciary Committee | Referred Mar 5, 2019Discharged May 10, 2019 |
| Administrative State, Regulatory Reform, and Antitrust Subcommittee | Referred Apr 8, 2019 |
Actions 11
Everything that happened, newest first.
- May 10, 2019Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-52, Part I.
- May 10, 2019Committee on the Judiciary discharged.
- May 10, 2019Placed on the Union Calendar, Calendar No. 30.
- Apr 8, 2019Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
- Apr 3, 2019Committee Consideration and Mark-up Session Held.
- Apr 3, 2019Ordered to be Reported (Amended) by Voice Vote.
- Mar 27, 2019Subcommittee Consideration and Mark-up Session Held.
- Mar 27, 2019Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
- Mar 6, 2019Referred to the Subcommittee on Health.
- Mar 5, 2019Introduced in House
- Mar 5, 2019Referred 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.
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Committee report
Congressional Budget Office cost estimate
- Apr 30, 2019H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019As ordered reported by the House Committee on Energy and Commerce on April 3, 2019
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 165, no. 39, March 5, 2019, page H2368.
Printed hearings 2
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| Serial No. 116-55 | THE PATIENT PERSPECTIVE: THE DEVASTATING IMPACTS OF SKYROCKETING DRUG PRICES ON AMERICAN FAMILIES45 pages | Oversight and Government Reform Committee | Jul 26, 2019 |
| Serial No. 116-17 | LOWERING THE COST OF PRESCRIPTION DRUGS: REDUCING BARRIERS TO MARKET COMPETITION252 pages | Energy and Commerce Committee | Mar 13, 2019 |
CRS reports 2
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 2
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| R46741 | Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress | Report | Mar 31, 2021 |
| R46221 | Drug Pricing and Pharmaceutical Patenting Practices Archived | Report | Feb 11, 2020 |
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 |
Titles 3
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes.
- Short Title(s) as Introduced
- Protecting Consumer Access to Generic Drugs Act of 2019
- Short Title(s) as Reported to House
- Protecting Consumer Access to Generic Drugs Act of 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; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
