What This Bill Does
This bill directs the Secretary of Health and Human Services to study how differences between two drug approval systems affect the ability to substitute interchangeable biological products (medications made from living organisms). The secretary must also update a public list of biological products to make it consistent with how regular drugs communicate their equivalence to each other.
Who It Affects
The Secretary of Health and Human Services is directly responsible for completing the required actions. The bill indirectly affects pharmaceutical companies that make biological products and regular drugs, as well as patients who use these medications.
Key Provisions
• The Secretary of Health and Human Services must complete a study within 12 months that examines how differences between the approval system for biological products and the approval system for regular drugs impact the substitution of interchangeable biological products. (Sec. 2(1))
• The Secretary must submit a report to Congress about the results of this study. (Sec. 2(2))
• The Secretary must update the "Purple Book" (a publicly available list of biological products) to make changes needed to align how substitutability of biological products is communicated with how drug equivalence is communicated, while keeping the two separate approval pathways intact. (Sec. 2(3))
What Changes
The Purple Book list will be updated based on the study findings to better communicate which biological products can be substituted for each other, matching the clearer system used for regular drugs.
Important Definitions
None defined in the bill text.
I
118TH CONGRESS
1ST SESSION H. R. 1790
To direct the Secretary of Health and Human Services to evaluate the
extent to which the substitution of interchangeable biological products
is impacted by differences between the system for determining a biological
product to be interchangeable and the system for assigning therapeutic
equivalence ratings to drugs, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 24, 2023
Mrs. MILLER-MEEKS (for herself, Ms. BARRAGA´N, Mr. MURPHY, and Ms.
KUSTER) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce
A BILL
To direct the Secretary of Health and Human Services to
evaluate the extent to which the substitution of inter-
changeable biological products is impacted by differences
between the system for determining a biological product
to be interchangeable and the system for assigning thera-
peutic equivalence ratings to drugs, and for other pur-
poses.
Be it enacted by the Senate and House of Representa-
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tives of the United States of America in Congress assembled,
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•HR 1790 IH
SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Biologics Competition
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Act of 2023’’.
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SEC. 2. STUDY ON THE SUBSTITUTION OF INTERCHANGE-
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ABLE BIOLOGICAL PRODUCTS.
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Not later than 12 months after the date of enactment
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of this Act, the Secretary of Health and Human Services
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shall—
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(1) complete a study to evaluate the extent to
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which the substitution of interchangeable biological
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products licensed under section 351 of the Public
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Health Service Act (42 U.S.C. 262) may be im-
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pacted by differences between the system for deter-
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mining a biological product to be interchangeable
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under section 351(k)(4) of such Act (42 U.S.C.
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262(k)(4)) and the system for assigning therapeutic
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equivalence ratings to drugs approved under section
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505 of the Federal Food, Drug, and Cosmetic Act
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(21 U.S.C. 355);
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(2) submit a report to the Congress on the re-
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sults of the study under paragraph (1); and
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(3) update the list published under section
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351(k)(9)(A) of the Public Health Service Act (42
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U.S.C. 262(k)(9)(A)) (commonly referred to as the
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‘‘Purple Book’’) to implement such changes as the
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Secretary deems necessary to harmonize the ap-
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•HR 1790 IH
proach for communicating the substitutability of
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interchangeable biological products with the ap-
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proach for communicating therapeutic equivalence
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ratings assigned to drugs, with the goals of—
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(A) minimizing any impediments to the
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substitution of interchangeable biological prod-
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ucts; and
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(B) maintaining the distinct pathways by
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which biological products are licensed under
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section 351 of the Public Health Service Act
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(42 U.S.C. 262) and drugs are approved under
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section 505 of the Federal Food, Drug, and
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Cosmetic Act (21 U.S.C. 355).
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Æ
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