H.R. 7649House117th Congress (2021-2023)In Committee

To direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes.

AI-Generated Summary

Updated February 8, 2026 at 11:06 AM UTC

The bill requires the Secretary of Health and Human Services to create a public docket within 90 days of the law’s enactment so the public can comment on what factors should be considered when reviewing any proposed change to an approved risk evaluation and mitigation strategy (REMS). The docket must stay open for at least 90 days. It also orders the Government Accountability Office to report by the end of 2026 on how many REMS changes have been approved, any patient‑access or provider‑administration issues that resulted, and how those issues were addressed.

Key Provisions

HHS must open a public docket for comments on factors to consider in reviewing proposed REMS modifications within 90 days of enactment, and keep it open for at least 90 days.
The docket may be closed only after the minimum 90‑day period has passed.
The GAO must deliver a report to the House Energy and Commerce Committee and the Senate HELP Committee by Dec. 31, 2026 detailing the number of REMS modifications granted, any patient‑access or provider‑administration problems that arose, and how those problems were resolved.

Legislative Activity

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1 earlier action

HouseIntro Referral Latest Action

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

May 3, 2022

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HouseIntro Referral

Introduced in House

May 3, 2022

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

May 3, 2022

Bill Text

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Introduced in HouseIssued May 3, 2022

117th CONGRESS

2d Session

H. R. 7649

IN THE HOUSE OF REPRESENTATIVES

May 3, 2022

Mr. Joyce of Pennsylvania (for himself, Ms. Matsui, and Mr. Griffith) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To direct the Secretary of Health and Human Services to open a public docket for the submission of public comments regarding factors that should be taken into consideration when reviewing a proposed modification to an approved risk evaluation and mitigation strategy, and for other purposes.

Public docket on proposed modifications to approved strategies

(a)

In general

Not later than 90 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall open a public docket for the submission of public comments regarding factors that should be taken into consideration when a proposed modification to an approved risk evaluation and mitigation strategy is reviewed under section 505–1(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 255–1(h)), including factors related to patient access to the drug that is the subject of the strategy and provider administration. The Secretary may close such public docket not earlier than 90 days after such docket is opened.

(b)

GAO report

Not later than December 31, 2026, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on—

(1)

the number of proposed modifications to an approved risk evaluation and mitigation strategy the Secretary has granted under section 505–1(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 255–1(h));

(2)

any issues affecting patient access to the drug that is the subject of the strategy or provider administration that arose as a result of such modifications; and

(3)

how such issues were resolved, as applicable.