Bill Details
View committees (2)
View cosponsors (20)
- Rep. Joyce, John [R-Pennsylvania-13]
- Rep. Gottheimer, Josh [D-New Jersey-5]
- Rep. Tenney, Claudia [R-New York-24]
- Rep. Yakym, Rudy [R-Indiana-2]
- Rep. Morelle, Joseph D. [D-New York-25]
- Rep. Hudson, Richard [R-North Carolina-9]
- Rep. Bean, Aaron [R-Florida-4]
- Rep. Miller-Meeks, Mariannette [R-Iowa-1]
- Rep. Allen, Rick W. [R-Georgia-12]
- Rep. Van Duyne, Beth [R-Texas-24]
- Rep. Peters, Scott H. [D-California-50]
- Rep. Moore, Blake D. [R-Utah-1]
- Rep. Crenshaw, Dan [R-Texas-2]
- Rep. Dunn, Neal P. [R-Florida-2]
- Rep. Hern, Kevin [R-Oklahoma-1]
- Rep. Carey, Mike [R-Ohio-15]
- Rep. Shreve, Jefferson [R-Indiana-6]
- Rep. Pfluger, August [R-Texas-11]
- Rep. Sessions, Pete [R-Texas-17]
- Rep. McDowell, Addison P. [R-North Carolina-6]
AI Summary This summary was generated by AI from the bill text. AI can get information wrong.
This bill would give some newer gene-based medicines a longer period of protection before they are treated like drugs that can be chosen for Medicare price negotiations. In simple terms, it is meant to help support access to advanced treatments that use genetically targeted technology by giving them more time on the market before certain federal drug-price rules apply. The bill says these products would get 11 years instead of 7 years before being included under this rule, if they meet the new definition in the bill.
- It changes part of the Social Security Act that defines when a drug is considered a “qualifying single source drug” for these rules.
- For a regular drug, the waiting period stays at 7 years.
- For an “advanced drug product,” the waiting period would be 11 years.
- An advanced drug product is defined as a drug that uses genetically targeted technology to affect the function of a gene or the gene’s product, including by reducing, increasing, or turning on that function.
Official Summaries
Maintaining Investments in New Innovation Act
This bill requires drug products with genetically targeted technology to have had market approval for at least 11 years in order to qualify for the Medicare Drug Price Negotiation Program. (The program requires the Centers for Medicare & Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation.)
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1672 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1672
To amend title XI of the Social Security Act to protect access to
genetically targeted technologies.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 27, 2025
Mr. Davis of North Carolina (for himself, Mr. Joyce of Pennsylvania,
Mr. Gottheimer, Ms. Tenney, Mr. Yakym, Mr. Morelle, Mr. Hudson, Mr.
Bean of Florida, Mrs. Miller-Meeks, Mr. Allen, Ms. Van Duyne, Mr.
Peters, Mr. Moore of Utah, and Mr. Crenshaw) introduced the following
bill; which was referred to the Committee on Energy and Commerce, and
in addition to the Committee on Ways and Means, 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
_______________________________________________________________________
A BILL
To amend title XI of the Social Security Act to protect access to
genetically targeted technologies.
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 ``Maintaining Investments in New
Innovation Act''.
SEC. 2. AMENDMENT TO DEFINITION OF QUALIFYING SINGLE SOURCE DRUG.
Section 1192(e) of the Social Security Act (42 U.S.C. 1320f-1(e))
is amended--
(1) in paragraph (1)(A)(ii), by inserting ``(or, in the
case of an advanced drug product (as defined in paragraph (4)),
11 years)'' after ``7 years''; and
(2) by adding at the end the following new paragraph:
``(4) Advanced drug product defined.--For purposes of
paragraph (1)(A)(ii), the term `advanced drug product' means a
drug that incorporates or utilizes a genetically targeted
technology (as defined in section 529A(c)(2) of the Federal
Food, Drug, and Cosmetic Act) that may result in the modulation
(including suppression, up-regulation, or activation) of the
function of a gene or its associated gene product.''.
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