United States 117th Congress Status: Died 1 R cosponsors

HR 7377 — Modernizing Therapeutic Equivalence Rating Determination Act

Last action — Referred to the Subcommittee on Health.

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. Died in session

This bill died with 117th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

Modernizing Therapeutic Equivalence Rating Determination Act This bill requires the Food and Drug Administration (FDA) to provide a therapeutic equivalence rating for certain new drug applications if the applicant requests such a rating. Upon request in the application, the FDA must provide such a rating for a new drug application that relies on information from studies not conducted by the applicant and that the applicant does not have a right to reference or use (commonly referred to as a 505(b)(2) application). The FDA must provide the rating no later than 30 days after the application's approval. (A drug is a therapeutic equivalent of another if they produce the same clinical effect and have the same safety profile. Typically, for certain generic drugs, the FDA rates the therapeutic equivalence of that generic drug to another drug, such as the brand name version. Currently, an applicant seeking approval of a drug through a 505(b)(2) application typically only receives an equivalence rating by requesting one from the FDA in a separate petition.)

Bill Text

Sections of law this bill changes

1 section in 1 law

From the bill's own amending language, matched to the official United States Code (current through Public Law 119-124).

Federal food, drug, and cosmetic act · 21 U.S.C. ch. 9 1 section
  • § 355 New drugs Amends

    21 U.S.C. § 355 — at 355(j)(7)(A)

    The law today

    (a) Necessity of effective approval of application No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug. (b) Filing application; contents (1) (A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application— (i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use; (ii) a full list of the articles used as components of such drug; (iii) a full statement of the composition of such drug; (iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (v) such samples of such drug and of the articles used as components thereof as the Secretary may require; (vi) specimens of the labeling proposed to be used for such drug; (vii) any assessments required under section 355c of this title; and (viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that— (I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or (II) claims a method of using such drug for which approval is sought or has been granted in the application. (B) If an application is filed under this subsection for a drug, and a patent of the type described in subparagraph (A)(viii) is issued after the filing date but before approval of the application, the applicant shall amend the application to include the patent number and expiration date. (2) An application submitted under paragraph (1) for a drug for which the investigations described in clause (A) of such paragraph and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted shall also include— (A) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the drug for which such investigations were conducted or which claims a use for such drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under paragraph (1) or subsection (c)— (i) that such patent information has not been filed, (ii) that such patent has expired, (iii) of the date on which such patent will expire, or (iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; and (B) if with respect to the drug for which investigations described in paragraph (1)(A) were conducted information was filed under paragraph (1) or subsection (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use. (3) Notice of opinion that patent is invalid or will not be infringed.— (A) Agreement to give notice.— An applicant that makes a certification described in paragraph (2)(A)(iv) shall include in the application a statement that the applicant will give notice as required by this paragraph. (B) Timing of notice.— An applicant that makes a certification described in paragraph (2)(A)(iv) shall give notice as required under this paragraph— (i) if the certification is in the application, not later than 20 days after the date of the postmark on the notice with which the Secretary informs the applicant that the ...

    137 other bills also change this section · Follow it → Official text at uscode.house.gov ↗

How this bill changes current law

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Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill modifies the procedures for therapeutic equivalence determinations for certain drug applications.

  • 21 U.S.C. 355(j)(7)(A)

    (v)(I) The Secretary shall make a determination under clause (i)(III)-- (aa) with respect to an application submitted under this subsection, at the time of approval of such application or not later than 30 days after the date of such approval; or (bb) with respect to an application submitted under subsection (b)(2), at the time of approval of such application or not later than 30 days after the date of such approval, provided that the sponsor requests such a determination in the original application, in a form prescribed by the Secretary. (II) When the Secretary makes a determination under clause (i)(III), the Secretary shall, in revisions made to the list pursuant to clause (ii), include such information for such drug. (III) When the Secretary makes a determination under clause (i)(III) with respect to a drug, the Secretary shall, at the same time, make such a determination with respect to any other drug-- (aa) whose application under subsection (b)(2) was approved; (bb) which references the same listed drug as the application for the first drug for which such determination is made; and (cc) for which there is a citizen petition pending requesting that the Secretary make a determination under clause (i)(III).

    This addition establishes specific timelines and conditions under which the Secretary must make therapeutic equivalence determinations for approved drug applications.

Action History

  1. Referred to the Subcommittee on Health.

  2. Introduced in House

  3. Introduced in House

  4. Referred to the House Committee on Energy and Commerce.

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

Show all 546 →

"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

healthcare health-insurance
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Frequently asked questions

What does HR 7377 do?
Modernizing Therapeutic Equivalence Rating Determination Act This bill requires the Food and Drug Administration (FDA) to provide a therapeutic equivalence rating for certain new drug applications if the applicant requests such a rating. Upon request in the application, the FDA must provide such a rating for a new drug application that relies on information from studies not conducted by the applicant and that the applicant does not have a right to reference or use (commonly referred to as a 505(b)(2) application). The FDA must provide the rating no later than 30 days after the application's approval. (A drug is a therapeutic equivalent of another if they produce the same clinical effect and have the same safety profile. Typically, for certain generic drugs, the FDA rates the therapeutic equivalence of that generic drug to another drug, such as the brand name version. Currently, an applicant seeking approval of a drug through a 505(b)(2) application typically only receives an equivalence rating by requesting one from the FDA in a separate petition.)
Who sponsors HR 7377?
HR 7377 is sponsored by Curtis, John R. (Republican).
What is the current status of HR 7377?
This bill died with 117th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 7377?
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