Current status is Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

119th CONGRESS

1st Session

H. R. 3042

1. Short title
2. Economically distressed zones
3. Authority to support development of population health products

1. Short title

This Act may be cited as the "Medical Manufacturing, Economic Development, and Sustainability Act of 2025" or the "MMEDS Act of 2025".

2. Economically distressed zones

(a) In general - Chapter 1 of the Internal Revenue Code of 1986 is amended by adding at the end the following new subchapter:

(b) Effective date - The amendments made by this section shall apply to taxable years beginning after December 31, 2024.

3. Authority to support development of population health products

(a) Definitions -

(1) Qualified countermeasure - Subparagraph (A) of section 319F–1(a)(2) of the Public Health Service Act (42 U.S.C. 247d–6a(a)(2)) is amended to read as follows:

(A) Qualified countermeasure - The term "qualified countermeasure" means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), that the Secretary determines to be a priority consistent with sections 302(2) and 304(a) of the Homeland Security Act of 2002—

(i) - to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease), toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security; or

(ii) - to diagnose, mitigate, prevent, or treat harm from an underlying non-communicable disease which, combined with pandemic influenza or an emerging infectious disease, may result in adverse health consequences or serious threat to one or more vulnerable American populations (as defined in section 319L(a)) in an epidemic or pandemic.

(2) Other definitions - Subsection (a) of section 319L of the Public Health Service Act (42 U.S.C. 247d–7e) is amended by adding at the end the following new paragraphs:

(11) Population health product - The term "population health product" means a widely available drug to diagnose, mitigate, prevent, or treat harm from an underlying non-communicable disease which, combined with pandemic influenza or an emerging infectious disease, may result in adverse health consequences or a serious threat to one or more vulnerable American populations in an epidemic or pandemic.

(12) Vulnerable American populations - The term "vulnerable American populations" means children, pregnant women, older adults, minority populations, and other at-risk individuals with relevant characteristics that warrant consideration during the process of researching and developing such countermeasures and products.

(b) Strategic initiatives - Clause (ii) of section 319L(c)(4)(F) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(4)(F)) is amended to read as follows:

(ii) - threats that consistently exist or continually circulate and have a significant potential to become a pandemic, such as pandemic influenza and emerging infectious diseases in combination with underlying non-communicable diseases, which may include the advanced research and development, manufacturing, and appropriate stockpiling of qualified pandemic or epidemic products, and products, technologies, or processes to support the advanced research and development of such countermeasures (including multiuse platform technologies for diagnostics, vaccines, and therapeutics; virus seeds; clinical trial lots; novel virus strains; and antigen and adjuvant material); and

(c) At-Risk individuals - Paragraph (6) of section 319L(c) of the Public Health Service Act (42 U.S.C. 247d–7e(c)) is amended to read as follows:

(6) At-risk individuals - In carrying out the functions under this section, the Secretary may give a priority to advanced research and development of—

(A) - qualified countermeasures and qualified pandemic or epidemic products likely to be safe and effective with respect to vulnerable American populations; and

(B) - population health products likely to protect vulnerable American populations with underlying non-communicable diseases from disproportionate harm in epidemics and pandemics.

(d) Other authorities - Section 319L(c) of the Public Health Service Act (42 U.S.C. 247d–7e(c)) is amended by adding at the end the following:

(8) Timely delivery of population health products to at-risk individuals - The Secretary shall collaborate with the Administrator of the Centers for Medicare & Medicaid Services, the Secretary of Defense, the Secretary of Veterans Affairs, the Commissioner of Food and Drugs, and the heads of other Federal agencies involved with approval and distribution of health products to assure that such Federal agencies distribute approved population health products as promptly and effectively as possible, and as continuously as possible, to protect vulnerable American populations from harm in epidemics and pandemics.

(9) Report on need for incentivizing development of population health products - Not later than 90 days after the date of enactment of the Medical Manufacturing, Economic Development, and Sustainability Act of 2025, the Secretary shall examine and report to the Congress on—

(A) - the extent to which the health of aging Americans, African Americans, Hispanics, Native Americans, veterans, or other vulnerable American populations has been disproportionately harmed by the COVID–19 pandemic and prior epidemics and pandemics;

(B) - the population health products currently available and whether there is a need for additional innovation and development to produce population health products to reduce the exposure of vulnerable American populations to risk of disproportionate harm in epidemics and pandemics; and

(C) - whether the Secretary recommends providing the same incentives for the development and marketing of population health products as is given with respect to covered infectious disease products under the Federal Food, Drug, and Cosmetic Act, including under section 505E of such Act.