Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
Latest action · Sep 29, 2021 Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16.
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.
- IntroducedApr 28, 2021
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission to sue in court or institute administrative proceedings to enforce this prohibition.
Generally, product-hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a changed, modified, or reformulated version of the reference drug that shares an indication (what the drug is used for) with the reference drug.
The bill presumes product hopping has occurred when a reference drug manufacturer engages in a hard switch or a soft switch. A hard switch occurs when, after receiving notice of an application for Food and Drug Administration (FDA) approval to market a generic (or biosimilar) version of the reference drug, the manufacturer markets a follow-on product and (1) the FDA withdraws approval of the reference drug at the manufacturer's request, or (2) the manufacturer announces the withdrawal or discontinuance of the reference drug or destroys the drug's inventory in a manner that impedes generic competitors.
Furthermore, the bill presumes that a soft switch occurred if a reference drug manufacturer (1) markets a follow-on product, and (2) takes actions that disadvantage the reference drug relative to that follow-on product in a way that impedes competition from a generic drug.
A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.
Cosponsors 5
Members who signed on, in the order they did. Signatures ran from Apr 28, 2021 to Sep 28, 2021, with 3 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-NY | Carolyn B. Maloney | Original | Apr 28, 2021 |
| D-NY | Jerrold Nadler | Original | Apr 28, 2021 |
| R-CO | Ken Buck | Original | Apr 28, 2021 |
| D-DC | Eleanor Holmes Norton | May 7, 2021 | |
| D-FL | Val Butler Demings | Sep 28, 2021 |
Actions 4
Everything that happened, newest first.
- Sep 29, 2021Committee Consideration and Mark-up Session Held.
- Sep 29, 2021Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16.
- Apr 28, 2021Introduced in House
- Apr 28, 2021Referred to the House Committee on the Judiciary.
Related bills 3
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 1435 | Affordable Prescriptions for Patients Act of 2021 | Related bill | Jul 29, 2021 |
| HR 5237 | Reduced Costs and Continued Cures Act of 2021 | Related bill | Nov 1, 2022 |
| HR 5260 | Reduced Costs and Continued Cures Act | Related bill | Nov 1, 2022 |
Subjects
Assigned by the Library of Congress. Policy area: Commerce.
- Administrative remedies
- Civil actions and liability
- Commerce
- Competition and antitrust
- Consumer affairs
- Drug safety, medical device, and laboratory regulation
- Federal Trade Commission (FTC)
- Health care costs and insurance
- Inflation and prices
- Intellectual property
- Judicial review and appeals
- Manufacturing
- Prescription drugs
Text 1
Each version as it was printed, newest first.
- Apr 28, 2021Introduced 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.