S. 2103 – Affordable Insulin Approvals Now Act

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Updated April 14, 2026 at 6:56 AM UTC

The Affordable Insulin Approvals Now Act is designed to speed up the approval process for insulin biologic products and make them more affordable. It changes the rules so that any insulin application filed by Dec. 31, 2019 can continue to be reviewed past the March 23, 2020 deadline, and once approved it is treated as a license under the Public Health Service Act. The changes affect insulin manufacturers and the federal agencies that review and approve these products.

Key Provisions

Amends the Biologics Price Competition and Innovation Act to add special treatment for pending insulin applications filed on or before Dec. 31, 2019.
Requires the Secretary to keep reviewing and approving those insulin applications even if the review extends beyond March 23, 2020.
Treats any listed drug referenced in such applications as a listed drug under the FD&C Act, regardless of its licensing status during review.
Deems the final approval of these applications to be a license for the insulin product under section 351 of the Public Health Service Act, effective on the later of March 23, 2020 or the actual approval date.

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 S4809)

Health, Education, Labor, and Pensions Committee

July 11, 2019

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SenateIntro Referral

Introduced in Senate

July 11, 2019

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S4809)

Health, Education, Labor, and Pensions Committee

July 11, 2019

Floor Debate

1 member

What members said about S. 2103 on the floor

1 Democrat

Sen. Richard J. DurbinD-IL · Jul 11, 2019

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

Sen. Richard J. DurbinD-IL · Jul 11, 2019

Mr. 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 11, 2019

II

116th CONGRESS

1st Session

S. 2103

IN THE SENATE OF THE UNITED STATES

July 11, 2019

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

A BILL

To improve access to affordable insulin.

1.

Short title

This Act may be cited as the Affordable Insulin Approvals Now Act.

2.

Deemed approval under section 351

Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (Public Law 111–148) is amended—

(1)

by striking An amended and inserting the following:

(A)

In general

An amended

; and

(2)

by adding at the end the following:

(B)

Treatment of certain pending applications

With respect to an application for an insulin biological product submitted under subsection (b)(2) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) with a filing date that is not later than December 31, 2019, until the Secretary makes a determination on final approval with respect to such application, the Secretary shall continue to review and approve (as appropriate) such application under such section 505, even if such review and approval process continues after March 23, 2020. For purposes of completing the review and approval process for such an application, any listed drug referenced in the application shall be treated as a listed drug under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, even if such listed drug is deemed licensed under section 351 of the Public Health Service Act during such review and approval process. Effective on the later of March 23, 2020, or the date of approval under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act of any such application, such approved application shall be deemed to be a license for the biological product under section 351 of the Public Health Service Act.

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