Bill Summary
The "FDA Modernization Act 3.0" is a piece of legislation aimed at updating regulatory requirements for nonclinical testing methods used in the development of drugs and medical products. The Act mandates that the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, publish an interim final rule within one year of its enactment. This rule is intended to revise existing regulations in the Code of Federal Regulations (CFR) to replace references to traditional "animal" testing with broader terminology encompassing "nonclinical" tests, which may include alternative testing methods.
Specifically, the legislation requires amendments to various sections of the CFR to ensure consistency with recent changes made to the Federal Food, Drug, and Cosmetic Act (FDCA) regarding nonclinical testing. The rule will take effect immediately upon publication, bypassing the requirement for further justification typically necessary for such regulatory changes. Additionally, the Act includes a technical amendment to clarify the organization of the FDCA.
Overall, this legislation reflects a shift towards modernizing and potentially reducing reliance on animal testing in the drug approval process, aligning with advancements in scientific methodologies.
Possible Impacts
The FDA Modernization Act 3.0, as outlined in the provided legislation, can impact people in several ways. Here are three examples:
1. **Reduction in Animal Testing**: By replacing references to "animal" tests with "nonclinical tests," the legislation could lead to a significant decrease in the use of animals for testing drugs and medical products. This change may be welcomed by animal rights advocates and those concerned with ethical treatment of animals. Consequently, people who support animal welfare may feel positively about the shift towards alternative testing methods, leading to broader societal acceptance of such practices.
2. **Faster Drug Development and Approval**: The interim final rule allows the FDA to implement nonclinical testing methods more swiftly, potentially accelerating the development and approval of new drugs. This could benefit patients waiting for new treatments by reducing the time it takes for innovative therapies to reach the market. As a result, individuals with chronic or life-threatening conditions might gain quicker access to necessary medications, improving their health outcomes.
3. **Impact on Pharmaceutical Industry Practices**: The changes to regulations and testing methods may prompt pharmaceutical companies to invest in new technologies and approaches for drug testing. This could lead to increased research and development of alternative testing methods, such as computer modeling or in vitro (test tube) studies. While this could foster innovation within the industry, it may also require companies to adapt their processes and training for employees, which could have implications for job roles and the overall workforce within the pharmaceutical sector.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 355 Engrossed in Senate (ES)]
<DOC>
119th CONGRESS
1st Session
S. 355
_______________________________________________________________________
AN ACT
To require the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs, to publish a final rule relating to
nonclinical testing methods.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FDA Modernization Act 3.0''.
SEC. 2. REGULATIONS ON NONCLINICAL TESTING METHODS.
(a) Interim Final Rule.--
(1) In general.--In order to ensure implementation of the
amendments to section 505(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(i)) made by section 3209(a) of the
Consolidated Appropriations Act, 2023 (Public Law 117-328; 136
Stat. 5821), not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services, acting
through the Commissioner of Food and Drugs, shall publish an
interim final rule--
(A) to amend the sections of title 21, Code of
Federal Regulations, described in paragraph (2) to
replace any references to ``animal'' tests, data,
studies, models, and research with a reference to
nonclinical tests, data, studies, models, and research;
and
(B) to add the definition of ``nonclinical test''
in section 505(z) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(z)) to sections 312.3,
314.3, 315.2, and 601.31 of title 21, Code of Federal
Regulations.
(2) CFR sections described.--The sections of title 21, Code
of Federal Regulations, described in this paragraph are the
following:
(A) Section 312.22(c).
(B) Section 312.23(a)(3)(iv).
(C) Section 312.23(a)(5)(ii).
(D) Section 312.23(a)(5)(iii).
(E) Section 312.23(a)(8).
(F) Section 312.23(a)(8)(i).
(G) Section 312.23(a)(8)(ii).
(H) Section 312.23(a)(10)(i).
(I) Section 312.23(a)(10)(ii).
(J) Section 312.33(b)(6).
(K) Section 312.82(a).
(L) Section 312.88.
(M) Section 314.50(d)(2).
(N) Section 314.50(d)(2)(iv).
(O) Section 314.50(d)(5)(i).
(P) Section 314.50(d)(5)(vi)(a).
(Q) Section 314.50(d)(5)(vi)(b).
(R) Section 314.93(e)(2).
(S) Section 315.6(d).
(T) Section 330.10(a)(2).
(U) Section 601.35(d).
(V) Any other section necessary to ensure
regulatory consistency with the amendments to section
505(i) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(i)) made by section 3209(a) of the
Consolidated Appropriations Act, 2023 (Public Law 117-
328; 136 Stat. 5821).
(3) Effectiveness of interim final rule.--Notwithstanding
subparagraph (B) of section 553(b) of title 5, United States
Code, the interim final rule issued by the Secretary of Health
and Human Services under paragraph (1) shall become immediately
effective as an interim final rule without requiring the
Secretary of Health and Human Services to demonstrate good
cause therefor.
(b) Technical Amendment.--Section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) is amended by designating the second
subsection (z) (relating to clinical trial diversity action plans), as
added by section 3601(a) of the Health Extenders, Improving Access to
Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of
2022 (division FF of Public Law 117-328), as subsection (aa).
Passed the Senate
Attest:
Secretary.
119th CONGRESS
1st Session
S. 355
_______________________________________________________________________
AN ACT
To require the Secretary of Health and Human Services, acting through
the Commissioner of Food and Drugs, to publish a final rule relating to
nonclinical testing methods.