S. 4878Senate118th Congress (2023-2025)In Committee

REMEDY Act

AI-Generated Summary

Updated January 20, 2026 at 6:17 PM UTC

The REMEDY Act amends the Federal Food, Drug, and Cosmetic Act to curb drug “evergreening” by changing how patent litigation and the 30‑month stay apply to abbreviated new drug applications (ANDAs). It requires an ANDA filer to designate a single “covered patent” for which a stay can be granted, and it adjusts the timing of infringement lawsuits based on whether the drug was approved before or after the law takes effect. The changes affect generic drug manufacturers filing ANDAs and the owners or licensees of patents on those drugs.

Key Provisions

Requires the holder of an approved ANDA to select one “covered patent” among listed patents; the selection cannot be changed later.
Limits the 30‑month stay to the selected covered patent and ties eligibility to filing dates relative to the act’s enactment.
Mandates that infringement actions must be brought before the ANDA submission date for the covered patent (or any patent for drugs approved before the act).
Updates multiple sections of the law (c)(3)(C), (c)(3)(E)(ii), (j)(5)(B)(iii), and (j)(5)(F)(ii) to reflect the covered‑patent concept and new timing rules.
Ensures that decisions about infringement apply to the patent or covered patent as appropriate, aligning the language throughout the statute.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S5684-5685)

Health, Education, Labor, and Pensions Committee

July 31, 2024

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SenateIntro Referral

Introduced in Senate

July 31, 2024

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S5684-5685)

Health, Education, Labor, and Pensions Committee

July 31, 2024

Floor Debate

2 members

What members said about S. 4878 on the floor

2 Democrats

Sen. Jack ReedD-RI · Jul 31, 2024

Madam President, today, I am joining Senator Capito to introduce the Innovation in Pediatric Drugs Act of 2024 in order to improve access to needed therapies for children. Children are not just small…

Madam President, today, I am joining Senator Capito to introduce the Innovation in Pediatric Drugs Act of 2024 in order to improve access to needed therapies for children.

Children are not just small adults. Drugs affect their developing bodies differently, so new treatments need to be studied carefully to ensure that they are appropriately prescribed and that dosages are properly adjusted. Additionally, drugs that are designed to treat a specific condition in adults may have enormous benefits in treating completely different illnesses in kids, but research is needed to unlock these potentially lifesaving possibilities.

Unfortunately, drug development still leaves children behind. The legislation we are introducing today would help speed therapies to children who need them by making needed changes to the Best Pharmaceuticals for Children Act BPCA, and the Pediatric Research Equity Act, PREA--two laws that encourage and require the study of drugs in children.

Data resulting from BPCA and PREA studies are added to drug labels to give parents and providers essential information on the safety and efficacy of drugs used in children. I was proud to have helped author these laws when I

was a member of the Health, Education, Labor, and Pensions Committee. While we have made tremendous progress in advancing treatments for children because of these laws, there are gaps. For example, there is a loophole in PREA that exempts drug companies from pediatric study requirements when the treatment would only be used for a rare pediatric condition.

There are close to 7,000 rare diseases without appropriate treatments, and the vast majority of these diseases affect children as well as adults. But in developing new drugs also known as orphan drugs to treat rare diseases, pharmaceutical developers focus their research on adult patients only since they are not required study their impact on children.

And since the majority of new drugs approved by the Food and Drug Administration, FDA are orphan drugs, this means that the majority of newly approved drugs have not been studied for their impacts on kids. This leaves doctors, parents, and sick kids in the dark about the best possible treatments. Our bill closes this loophole to require studies for children so that they, too, can benefit from new and innovative treatments for rare diseases.

In addition to this change, the Innovation in Pediatric Drugs Act would invest in pediatric studies of older, off-patent drugs. The FDA incentives and requirements under BPCA and PREA work for many newer drugs but unfortunately cannot help encourage studies of older drugs. For this reason, in 2002, Congress authorized a program which funds the National Institutes of Health to conduct studies of off-patent drugs used in children that would never be completed otherwise. Drug studies are expensive, and costs have only increased since then, but the program has been flat-funded at $25 million since it was created more than 20 years ago. Our legislation would increase the authorization for the BPCA NIH program to ensure we have better data about older drugs to treat diseases in children.

Lastly, the Innovation in Pediatric Drugs Act would give FDA the authority it needs to ensure that legally required pediatric studies are completed in a timely manner. Due dates for studies required by PREA are typically deferred by FDA until after the approval of the drug for adults, but, FDA has no effective enforcement tools to ensure that these studies are completed on time--or at all.

I am pleased to be working with my colleague Senator Capito on pediatric health issues. We have worked closely for many years on pediatric cancer, first authoring the Childhood Cancer Survivorship, Treatment, Access, and Research, STAR Act in 2015. That bill was signed into law in 2018, and we worked to fully fund the law every year since.

I look forward to working with her as well as the sponsors of the House companion legislation, Representatives Anna Eshoo and Michael McCaul to move the Innovation in Pediatric Drugs Act forward, to give children and their families more options for treatments.

Sen. Richard J. DurbinD-IL · Jul 31, 2024

Madam President, I ask unanimous consent that the text of the bill be printed in the Record.

Sen. Richard J. DurbinD-IL · Jul 31, 2024

Madam President, I ask unanimous consent that the text of the bill be printed in the Record.

Bill Text

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Introduced in SenateIssued July 31, 2024

118th CONGRESS

2d Session

S. 4878

IN THE SENATE OF THE UNITED STATES

July 31, 2024

Mr. Durbin (for himself and Mr. Cassidy) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To amend the Federal Food, Drug, and Cosmetic Act with respect to approval of abbreviated new drug applications.

Short title

This Act may be cited as the Reforming Evergreening and Manipulation that Extends Drug Years Act or the REMEDY Act.

Amendments to ANDA approval provisions

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended—

(1)

in subsection (c)(2) by adding at the end the following: With respect to a drug approved on or after the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, when a holder of an approved application first files information under this paragraph with respect to one or more patents described in subsection (b)(1)(A)(viii), the holder shall select one such patent with respect to which the owner or licensee may receive the 30-month stay under paragraph (3)(C), as applicable; for purposes of paragraphs (3)(C) and (3)(E) and subsections (j)(5)(D)(iii) and (j)(5)(F)(ii), such patent shall be referred to as the covered patent. The selection of such covered patent may not be changed or amended.;

(2)

in subsection (c)(3)(C)—

(A)

in the matter preceding clause (i)—

(i)

by striking an action is brought for infringement and all that follows through the period at the end of the first sentence and inserting with respect to a drug approved under this subsection before the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, an action is brought for infringement of any patent that is the subject of the certification and for which information was submitted to the Secretary under paragraph (2) or subsection (b)(1) before the date on which the application (excluding an amendment or supplement to the application) was submitted, or, with respect to a drug approved under this subsection on or after the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, an action is brought for infringement of the covered patent (as described in paragraph (2)), before the date on which the application (excluding an amendment or supplement to the application) was submitted.; and

(ii)

by striking an action is brought before and inserting an action with respect to a patent or a covered patent, as applicable, is brought before; and

(B)

in clause (i), by striking decides that the patent and inserting decides that the patent or the covered patent, as applicable;

(3)

in the second sentence of subsection (c)(3)(E)(ii), by inserting with respect to any patent that claims a drug that was approved under this subsection before the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, or, with respect to a covered patent (as described in paragraph (2)) that claims a drug approved under this subsection on or after the date of enactment of such Act, after action for patent infringement;

(4)

in subsection (j)(5)(B)(iii)—

(A)

in the matter preceding subclause (I)—

(i)

by striking an action is brought for infringement and all that follows through the period at the end of the first sentence and inserting with respect to a drug approved under subsection (c) before the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, an action is brought for infringement of any patent that is the subject of the certification and for which information was submitted to the Secretary under subsection (b)(1) or (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted, or, with respect to a drug approved under subsection (c) on or after the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, an action is brought for infringement of the covered patent (as described in subsection (c)(2)) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted.; and

(ii)

by striking an action is brought before and inserting an action with respect to a patent or a covered patent, as applicable, is brought before; and

(B)

in subclause (I), by striking decides that the patent and inserting decides that the patent or covered patent, as applicable,; and

(5)

in the second sentence of subsection (j)(5)(F)(ii), by inserting with respect to any patent that claims a drug that was approved under subsection (c) before the date of enactment of the Reforming Evergreening and Manipulation that Extends Drug Years Act, or, with respect to a covered patent (as described in subsection (c)(2)) that claims a drug approved under subsection (c) on or after the date of enactment of such Act, after action for patent infringement.